GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

P230023 · W. L. Gore & Associates, Inc. · QZK · Jan 12, 2024 · Cardiovascular

Device Facts

• Record ID: P230023
• Device Name: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: QZK · Cardiovascular
• Decision Date: Jan 12, 2024
• Decision: APPR
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is indicated for endovascular repair in patients with thoracoabdominal aortic aneurysms and high-surgical risk patients with pararenal aortic aneurysms who have appropriate anatomy as described below: 1. Adequate iliac / femoral access and brachial / axillary access 2. Proximal (supraceliac) aortic neck treatment diameter range over 2 cm seal zone of 22 - 34 mm for aneurysms extending up to 6.5 cm or less above the origin of the most proximal branch vessel 3. Aortic neck angle ≤ 60° at the Aortic Component proximal seal zone 4. Iliac artery treatment diameter range of 8 - 25 mm and iliac artery seal zone length of at least 10 mm 5. Renal artery seal zone diameters between 4.0 - 10.0 mm 6. Celiac and superior mesenteric artery seal zone diameters between 5.0 - 12.0 mm 7. ≥ 15 mm seal zone length in renal arteries, superior mesenteric artery, and celiac artery 8. Visceral segment of aorta (3 cm proximal through 9.5 cm distal to the most proximal visceral artery) must be ≥ 20 mm in diameter

Device Story

The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) is a modular endovascular system for treating aneurysms involving the visceral aorta. It consists of an Aortic Component (implanted in the visceral segment with four antegrade portals), Branch Components (GORE® VIABAHN® VBX), a Distal Bifurcated Component (GORE® EXCLUDER® Iliac Branch), and Contralateral Leg/Extender components. The device is delivered via femoral/iliac and brachial/axillary access by vascular surgeons. The Aortic Component uses multi-stage deployment with removable guidewire tubes to facilitate branch vessel cannulation. The system excludes the aneurysm from blood flow, preserving perfusion to the celiac, superior mesenteric, and renal arteries. Clinical benefits include a minimally invasive alternative to open surgical repair, potentially reducing operative mortality and morbidity. Healthcare providers use fluoroscopic imaging to guide placement and monitor for endoleaks or device integrity. The device is intended for patients with specific anatomical criteria, including high-surgical risk PAAA patients.

Clinical Evidence

Prospective, non-randomized, multicenter pivotal study (IDE G150071) of 102 subjects with TAAA or PAAA. Co-primary endpoints: 30-day composite of Uncomplicated Technical Success and Procedural Safety; 12-month composite of Clinically Significant Reintervention and Lesion-Related Mortality. 30-day success was 77.5% (90% CI: 69.6, 84.1). 12-month success was 70.6% (90% CI: 61.4, 78.7). Technical success per SVS standards was 99%. No lesion-related mortality through 12 months. Adverse events included paraplegia (2%), paraparesis (2.9%), and renal failure requiring dialysis (2%).

Technological Characteristics

Modular endoprosthesis system. Materials: ePTFE/FEP graft, Nitinol (NiTi) stent, stainless steel, gold. Aortic Component: 31-37mm proximal diameter, 160mm length. Delivery: femoral/iliac and brachial/axillary access. Sterilization: Ethylene Oxide (EO). Shelf life: 3 years. Connectivity: None (standalone).

Indications for Use

Indicated for endovascular repair of thoracoabdominal aortic aneurysms (TAAA) and high-surgical risk pararenal aortic aneurysms (PAAA) in patients ≥19 years with appropriate vascular anatomy (adequate access, specific seal zone diameters/lengths, and aortic neck angles). Contraindicated in patients with sensitivities to ePTFE, FEP, Nitinol, stainless steel, or gold; conditions threatening graft infection; or heparin hypersensitivity/HIT type II.

Regulatory Classification

Identification

Endovascular repair of thoracoabdominal and pararenal aortic lesions

Reference Devices

• GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021)
• GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004)
• GORE® EXCLUDER® AAA Endoprosthesis (P020004)
• GORE® TAG® Conformable Thoracic Endoprosthesis

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

## I. GENERAL INFORMATION

Device Generic Name: Endovascular Graft

Device Trade Name: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE)

Device Procode: QZK

Applicant’s Name and Address: W. L. Gore & Associates, Inc.
1505 North Fourth Street
Flagstaff, AZ 86004 U.S.

Date(s) of Panel Recommendation: None

Premarket Approval Application (PMA) Number: P230023

Date of FDA Notice of Approval: January 12, 2024

Breakthrough Device: Granted breakthrough device status on October 1, 2021 because of reasonable expectation that the device can provide more effective treatment of a life threatening disease, as well as due to lack of approved or cleared endovascular device alternates.

## II. INDICATIONS FOR USE

The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is indicated for endovascular repair in patients with thoracoabdominal aortic aneurysms and high-surgical risk patients with pararenal aortic aneurysms who have appropriate anatomy as described below:

1. Adequate iliac / femoral access and brachial / axillary access
2. Proximal (supraceliac) aortic neck treatment diameter range over 2 cm seal zone of 22 - 34 mm for aneurysms extending up to 6.5 cm or less above the origin of the most proximal branch vessel
3. Aortic neck angle ≤ 60° at the Aortic Component proximal seal zone
4. Iliac artery treatment diameter range of 8 - 25 mm and iliac artery seal zone length of at least 10 mm
5. Renal artery seal zone diameters between 4.0 - 10.0 mm
6. Celiac and superior mesenteric artery seal zone diameters between 5.0 - 12.0 mm
7. ≥ 15 mm seal zone length in renal arteries, superior mesenteric artery, and celiac artery
8. Visceral segment of aorta (3 cm proximal through 9.5 cm distal to the most proximal visceral artery) must be ≥ 20 mm in diameter

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## III. CONTRAINDICATIONS

The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is contraindicated in:

- Patients with known sensitivities or allergies to the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis materials including expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene (FEP), nickel titanium alloy (Nitinol), stainless steel, and gold.
- Patients who have a condition that threatens to infect the graft.
- Patients with known hypersensitivity to heparin, including patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II and cannot receive the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.

## IV. WARNINGS AND PRECAUTIONS

The warnings and precautions can be found in the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis labeling.

## V. DEVICE DESCRIPTION

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) provides endovascular treatment of aneurysms extending into the visceral segment of the aorta. The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is comprised of multiple required components, the Aortic Component, the Branch Components (GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis), the Distal Bifurcated Component (DBC) (GORE® EXCLUDER® Iliac Branch Endoprosthesis - Iliac Branch Component), and the Contralateral Leg Component (GORE® EXCLUDER® AAA Endoprosthesis - Contralateral Leg Endoprosthesis and/or GORE® EXCLUDER® AAA Endoprosthesis - Iliac Extender Endoprosthesis).

In addition to the required components, the DBC Extender Component (GORE® EXCLUDER® AAA Endoprosthesis - Aortic Extender) may be used as an optional component.

The use of each component within the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is described below:

> Aortic Component is implanted in the visceral segment of the aorta and has four portals to position the Branch Components. The Aortic Component is designed to provide proximal (supra celiac) sealing and anchoring within the aorta and is placed proximal to the Distal Bifurcated Component. The superior mesenteric artery (SMA), celiac artery (CA), and renal arteries (RAs) are perfused via four antegrade portals in the Aortic Component.

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> Branch Components are deployed in the four Aortic Component portals, extending into the SMA, CA and RAs.
> Distal Bifurcated Component is used to bifurcate from the Aortic Component to facilitate extension of the aneurysmal repair into the aortic bifurcation.
> Contralateral Leg Component is used to extend the repair distally into the iliac arteries. More than one Contralateral Leg Component may be used.
> DBC Extender Component is used as an optional component for additional sealing at the junction between the Aortic Component and the Distal Bifurcated Component.

The above device components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis and their intended anatomic treatment location are shown in Figure 1 (TAMBE Device).

Figure 1. Illustration of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

# Aortic Component - Endoprosthesis

The Aortic Component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is implanted in the visceral segment of the aorta and has four portals to position the Branch Components. The Aortic Component is designed to provide proximal (supra-celiac) sealing and anchoring within the aorta. The SMA, CA, and RAs are perfused via four antegrade portals in the Aortic Component. All Branch Components are delivered from brachial/axillary access during the endovascular repair.

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Figure 2 shows the Aortic Component in a perpendicular view to the Aortic Component central axis, while the same device from a perspective parallel to the device central axis or lumen view is shown in Figure 3.

Figure 2. Aortic Component - Perpendicular View
Figure 3. Aortic Component - Lumen View

The Aortic Component is constructed of an expanded polytetrafluoroethylene (ePTFE) / fluorinated ethylene propylene (FEP) graft and a Nitinol (NiTi) stent. The device is constrained on the delivery catheter by ePTFE / FEP sewn sleeves.

The Aortic Component is available in the configurations and sizes are listed in Table 1.

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Table 1. Aortic Component Configurations and Sizes¹

| Proximal Device Diameter (mm) | Distal Device Diameter (mm) | Intended Proximal Aortic Diameters² (mm) | Proximal Portals Diameter (mm) | Distal Portals Diameter (mm) | Overall Device Length (mm) |
| --- | --- | --- | --- | --- | --- |
| 31 | 20 | 22 - 29 | 8 | 6 | 160 |
| 37 | 20 | 27 - 34 | 8 | 6 | 160 |

¹ All device dimensions are nominal.
² Appropriate oversizing is built into recommended sizes.

The Aortic Component on the delivery catheter is tracked via femoral / iliac access and positioned with portals in proximity to the target branch vessels (SMA, CA, and RA). The Aortic Component utilizes multi-stage deployment to provide repositionability and to optimize working space within the aorta.

## Aortic Component – Delivery System

The Aortic Component delivery system (Figure 4) consists of the constrained endoprosthesis mounted on the delivery catheter. Three ePTFE/FEP deployment sleeves are used to constrain the endoprosthesis on the leading end of the delivery catheter. The Aortic Component has four removable guidewire tubes (RGTs) to facilitate pre-cannulation of guidewires through the portals. Deployment of all three sleeves initiates from the leading end (cranial) and proceeds toward the trailing end (caudal) of the delivery catheter (Figure 5).

Figure 4. Aortic Component Device Delivery System

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Figure 5. Aortic Component Constrained on Delivery System and Deployed

The delivery system is designed to enable partial deployment of the Aortic Component with the capability to constrain the anchors and re-position the device prior to full deployment. Additional deployment sleeves increase the ability to control the Aortic Component diameter during deployment and to facilitate the cannulation of branch vessels. The delivery system for the Aortic Component has three catheter lumens to isolate and accommodate the deployment lines.

With the Aortic Component positioned in the aorta at a level where the outlet of the proximal portals is 1 to $3\mathrm{cm}$ above the origin of the most proximal visceral artery, deployment initiates from the leading end and proceeds toward the trailing end of the delivery system.

Branch, Distal Bifurcated, Contralateral Leg and DBC Extender Components The following W. L. Gore & Associates, Inc. commercially available medical devices listed in Table 2 are used as components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis:

Table 2. Commercially Available Devices Used as Components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

| Device Component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis | Commercially Available Device | U.S. Device Approval Status |
| --- | --- | --- |
| Branch Components | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | Approved in PMA P160021. |
| Distal Bifurcated Component | GORE® EXCLUDER® Iliac Branch Endoprosthesis – Iliac Branch Component | Approved in PMA P020004. |
| DBC Extender Component | GORE® EXCLUDER® AAA Endoprosthesis - Aortic Extender | Approved in PMA P020004. |

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| Device Component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis | Commercially Available Device | U.S. Device Approval Status |
| --- | --- | --- |
| Contralateral Leg Component | GORE® EXCLUDER® AAA Endoprosthesis - Contralateral Leg Endoprosthesis
and/or
GORE® EXCLUDER® AAA Endoprosthesis - Iliac Extender Endoprosthesis
*Note:* The two devices listed above may be used interchangeably as needed. | Approved in PMA P020004/S004 and S124.
Approved in PMA P020004. |

Information regarding the overall TAMBE Device in terms of required materials, patient selection, recommended device sizing, anatomical requirements, and implant procedure are provided in the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Instructions for Use (IFU), as is information regarding the Aortic Component of the TAMBE Device in terms of recommended device sizing, anatomical requirements, device preparation and implant procedure.

For details regarding the other components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, please see the IFU for each of the commercially available devices listed in Table 2.

## VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are several other alternatives for the correction of thoracoabdominal aortic aneurysms (TAAA) and pararenal abdominal aortic aneurysms (PAAA) including medical management and open surgical repair. Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle.

## VII. MARKETING HISTORY

The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis has not been marketed in the United States (U.S.) or any foreign country.

## VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

A list of the potential adverse effects (e.g., complications) associated with the use of the device is provided in Table 3.

Table 3. List of Potential Adverse Effects

| allergic reaction and/or anaphylactoid response to Multiplanar Device Radiographs (X-Ray) contrast dye, anti-platelet therapy, device materials | fever |
| --- | --- |
| amputation | |
| anesthetic complications | heparin induced thrombocytopenia (HIT) |

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| aneurysm enlargement | infection (e.g., aneurysm, device, or access sites) |
| --- | --- |
| aneurysm rupture | irritation/inflammation |
| anemia | lymph fistula/complications |
| arterial or venous thrombosis and/or pseudoaneurysm | neurologic damage, local or systemic (e.g., stroke, paraplegia, paraparesis, numbness, spinal cord ischemia, transient ischemic attack) |
| arteriovenous fistula | occlusion of device or native vessel, single or multiple vessels |
| bleeding, hematoma, or coagulopathy | organ failure, single or multi system |
| bowel complications (e.g., ileus, transient ischemia, mesenteric ischemia, infarction, necrosis) | post-implantation syndrome |
| cardiac complications (e.g., angina, arrhythmia, myocardial infarction, congestive heart failure, hypotension, or hypertension) | prosthetic dilatation/rupture |
| catheter breakage | prosthetic thrombosis |
| death | pulmonary complications (e.g., atelectasis, pneumonia, respiratory failure, chronic obstructive pulmonary disease) |
| dissection, perforation, or rupture of the aortic vessel and surrounding vasculature | radiation injury |
| edema | renal complications (e.g., artery occlusion, contrast toxicity, insufficiency, injury, ischemia, failure) |
| embolism (micro and macro) with transient or permanent ischemia | reoperation/reintervention |
| endoleak | splenic injury (e.g., infarction, ischemia) |
| endoprosthesis: improper placement; incomplete deployment; migration; material failure; stent fracture; compression, kink, perigraft flow | stenosis |
| erectile dysfunction | surgical intervention/conversion |
| erosion | vascular spasm or vascular trauma (e.g., ilio-femoral vessel dissection, bleeding, perforation, rupture, death) |
| extremity ischemia or neurologic complications (e.g., nerve injury, claudication, buttock, or lower limb) | wound (e.g., infection, dehiscence, groin abscess) |
| genitourinary complications (e.g., ischemia, erosion, fistula, incontinence, urinary retention, hematuria, infection) | |

For the specific adverse events (AEs) that occurred in the clinical study, please see Section X below.

## IX. SUMMARY OF NONCLINICAL STUDIES

Nonclinical studies were completed to evaluate the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis that included bench, biocompatibility, sterilization, packaging and shelf life testing. The testing completed for the GORE®

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EXCLUDER® Thoracoabdominal Branch Endoprosthesis is described in the following sections.

# A. Non-Clinical Product Bench Testing

Non-clinical product bench testing was successfully completed for the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis as summarized in Table 4. Non-clinical product bench testing was developed based on the device risk assessment and is consistent with FDA's Guidance Document Non-Clinical Tests and Recommended Labeling of Intravascular Stents and Associated Delivery Systems, April 18, 2010, its addendum, Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, August 18, 2015, and BS EN ISO 25539-1.

Note: The specific engineering tests completed to support the three (3) year shelf life for the Aortic Component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis are denoted in Table 4 by an asterisk (*).

Table 4. Summary of Non-Clinical Product Bench Testing for the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Aortic Component - Endoprosthesis | | | |
| Post-Deployment Inspections* | Evaluate various post-deployment inspections including general visual, device integrity, and dimensional inspection. | Stent graft must meet required inspections (including measurement of length, inner diameter, portal diameter and portal to leading end stent distance) and be free of damage or other attributes that may adversely affect device function (e.g., lumen obstructions, holes, broken wire struts, gaps, delamination, pockets, flaps and misaligned portals). | PASS |
| Stent Graft Bond Strength* | Verify that Aortic Component stent frame is attached to graft without excessive damage when removed from deployment model. | Strength of bond securing the stent to the graft will allow the stent graft to be deployed without excessive damage. | PASS |
| Bend Radius* | Evaluate the minimum radius that the pressurized Aortic Component endoprosthesis can bend without kinking. Bend radius is defined as the minimum radius at which the stent graft does not kink. | The bend radius must be ≤ 12.6 mm. | PASS |
| Radial Force* | Measure the radial outward force of the Aortic Component endoprosthesis after deployment. | The radial outward force of the Aortic Component endoprosthesis must be comparable to that of the GORE® EXCLUDER® Conformable AAA Endoprosthesis. | PASS |
| Integral Water Permeability* | Evaluate the ability of the Aortic Component endoprosthesis to resist water leakage through holes in the graft material under pressure. | The water permeability of the device must be less than or equal to 5.15 mL/min/cm2. | PASS |
| Nitinol Material Analysis | Evaluate the chemical elements present in the bulk and on the surface of the wire of the Aortic Component | The chemical composition of a representative Nitinol wire material lot must meet internal specifications. | PASS |

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| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | endoprosthesis. Also examine the wire surface for contamination and defects. | The Austenitic Finish Transition Temperature of a representative nitinol wire material lot must be ≤ 35°C.
Characterization of the uniaxial tensile stress-strain behavior for each of the 6 Aortic Component Nitinol wire components. | |
| Nitinol Thermo-mechanical Properties | Evaluate the thermo-mechanical properties of the Aortic Component endoprosthesis. | When deployed at 37°C, the Aortic Component endoprosthesis must open without excessive invagination or any unacceptable obstruction to the flow in order to confirm the superelastic property of the Nitinol material in a final device configuration. | PASS |
| Corrosion Resistance | Evaluate the corrosion resistance of the Aortic Component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis for characterization purposes only. | The corrosion resistance will be comparable to that of the GORE® EXCLUDER® Endoprosthesis. | PASS |
| Radial Pulsatile Fatigue | Evaluate the radial pulsatile fatigue of the Aortic Component endoprosthesis. | The components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis will be durable to fatigue (physiologic motion/loading conditions) for an implantation duration equivalent to 10 years, without damage that would compromise device function. | PASS |
| **Aortic Component – Delivery Catheter** | | | |
| Catheter Working Length | Measure the working length of the Aortic Component delivery system prior to device deployment. | The working length of the catheter as measured from the leading end of the strain relief to the leading olive tip shall be 66-70 cm. | PASS |
| Catheter Leak | Evaluate the leak resistance of the Aortic Component delivery system. | The pressure at which leakage of the delivery catheter guideline lumen occurs must be the same as the GORE® EXCLUDER® Conformable AAA Endoprosthesis catheter. | PASS |
| Manifold Sealing | Measure the leakage through the Aortic Component delivery system handle in a simulated use environment. | At pulsatile pressure, the manifold seal must not leak at a rate higher than 2 mL/min. | PASS |
| Catheter Bond Strengths* | Evaluate the bond strengths of the Aortic Component delivery system. | The outer lumen to handle must withstand a minimum 13 inch-ounces of torque. All delivery system bonds must have a tensile strength of ≥ 8.1 lbz. | PASS |
| Catheter Angular Rotation to Failure | Evaluate the catheter angular rotation to failure of the Aortic Component delivery system. | With the tip restrained, the catheter shall allow at least 180° of handle rotation without mechanical damage or failure. | PASS |
| Lock Wire Attachment Tensile Strength* | Evaluate the tensile strength of the lock wire attachment of the Aortic Component delivery system. | The tensile strength of the lock wire bond to the handle screw assembly must be ≥ 12.0 lbz. | PASS |
| Constraining Loop Attachment Tensile Strength | Evaluate the tensile strength of the constraining loop attachment bond of the Aortic Component delivery system. | The tensile strength of the constraining loop bond to the handle assembly must be ≥8.0 lbz. | PASS |
| RGT Glue Beads* | Determine if the glue bead geometry of the Removable | All samples must restrict passage of the RGT through the representative sheath | PASS |

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| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | Guidewire Tubes (RGTs) used to aid cannulation of the Aortic Component portals will not be able to pass through the sheath alongside the Aortic Component delivery catheter. An RGT glue bead is applied to the end of the RGT to aid the physician in RGT removal and to prevent the RGT from inadvertently entering the patient during the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis procedure. | dimension (inner diameter = 0.2947”) alongside the Aortic Component delivery catheter. | |
| Guidewire Compatibility* | Determine the compatibility of the Aortic Component delivery catheter with a 0.035” guidewire and the compatibility of the RGTs with a 0.018” guidewire. | The catheter must be compatible with a 0.035” guidewire. The RGTs must be compatible with a 0.018” guidewire. Insertion shall be without obstruction or excessive force. | PASS |
| Flushable Guidewire Lumen* | Determine if the guidewire lumen of the Aortic Component is flushable. | The guidewire lumen of the Aortic Component catheter must be flushable. | PASS |
| Torqueability* | Determine the torque strength of the Aortic Component delivery catheter. | While rotating the handle, the tip must be able to rotate 180° from neutral in each direction. The partially constrained device must be able to be rotated 90° from neutral in each direction. | PASS |
| Introducer Sheath Compatibility: Insertion / Removal Ability* | Determine if the Aortic Component delivery catheter with crushed stent graft can be inserted and removed through the recommended introducer sheath. | The delivery catheter loaded with the crushed stent graft must be able to successfully pass through the recommended sheath; the entire catheter must successfully exit the sheath. | PASS |
| Introducer Sheath Compatibility: Retraction Force | Determine the peak force as the leading tip of the Aortic Component delivery catheter retracts over the lip of the introducer sheath and through the filled hemostasis valve of the introducer sheath after device deployment in a simulated use environment. | The retraction force must be less than the tensile strength of the leading tip of the Aortic Component delivery catheter. | PASS |
| Pushability and Trackability* | Determine the pushability and trackability of the Aortic Component in a simulated use environment. | With a 0.035” guidewire in place, the loaded catheter must be able to successfully pass through the recommended sheath. Must be able to push the Aortic Component through bends and position correctly in the aneurysm model. | PASS |
| Deployment Reliability* | Determine the deployment reliability of the Aortic Component in a simulated use environment. | The sewn sleeves must constrain the Aortic Component endoprosthesis with an outer diameter capable of being passed through the introducer sheath. After deployment, delivery catheter components must be removed without disrupting or dislodging the Aortic Component and successfully exit the introducer sheath. | PASS |

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| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | | The portals must be open upon deployment of proximal sleeve.
The Aortic Component must be able to be constrained by reducing the diameter at the proximal end after the initial unconstraining.

The constrained Aortic Component must be able to be moved proximally and distally and be rotated by 90° in both directions.

The proximal end of the Aortic Component endoprosthesis must fully open without invagination or any obstruction to flow.

The sewn sleeves must remain attached to the stent graft at deployment. | |
| Deployment Force* | Measure the force required to deploy each state of the Aortic Component in a simulated use environment. | The deployment force of each of the three deployment lines must be ≤ 5.0 lb_{f}. | PASS |
| Deployment Mechanism to Line Tensile Strength* | Measure tensile strength of the deployment knob to line attachment of the Aortic Component delivery catheter after deployment of the Aortic Component endoprosthesis. | The minimum acceptable knob to line tensile strength for all three deployment lines must be ≥ 5.5 lb_{f}. | PASS |
| **Aortic Component and Branch Components** | | | |
| Galvanic Corrosion | Determine the potential for galvanic corrosion between the Aortic Component and Branch Components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis for characterization purposes only. | The corrosion rate and mass loss rate will be calculated from the corrosion current. | Characterization |
| Pushability and Trackability | Evaluate pushability and trackability of the Branch Components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in a simulated use environment. | With a 0.035” guidewire in place, the loaded Branch Component catheter must be able to successfully pass through the recommended introducer sheath. Must be able to push the Branch Components through bends and position correctly in the aneurysm model. | PASS |
| Deployment Reliability | Assess the ability of each Branch Component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis to deploy at the target location and to reliably withdraw each Branch Component catheter in a simulated use environment. | The Branch Component endoprostheses will fully deploy, and the Branch Component catheters will each be reliably withdrawn and successfully exit the sheath without dislodging the Aortic Component endoprosthesis. | PASS |
| Deployment Accuracy | Measure the deployment accuracy of the Aortic Component or Branch Components in a simulated use environment. | The difference between the in-vitro target (intended) deployment site in the aneurysm model and the actual final proximal deployed location shall be | PASS |

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| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | | measured and be within ± 5 mm of the desired target location. | |
| Durability Evaluation – Aortic Component to Branch Components (Radial Pulsatile, Respiratory-Induced Motion and Musculoskeletal-Induced Motion) | Evaluate fatigue performance of the Branch Components and Aortic Component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis. | The Branch and Aortic Components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis will demonstrate they are durable to physiologic motion/loading conditions for an implantation duration equivalent to 10 years, without damage that would compromise endoprosthesis function. | PASS |
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Implant System and Component Interaction) | | | |
| Radiopacity | Evaluate the visibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis under fluoroscopy. | The visibility of the Aortic Component radiopaque marker bands must be similar to or greater than that of the GORE® TAG® Conformable Thoracic Endoprosthesis marker bands. | PASS |
| MRI Safety and Compatibility | Evaluate the safety of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in an MR environment of ≤ 3.0 Tesla. | The endoprosthesis will not present an additional hazard or risk when implanted in a patient undergoing an MRI procedure or who may be present in a MR environment of ≤ 3.0 Tesla. The device may affect MRI quality depending on the pulse sequence that is used and the imaging area of interest. | PASS |
| Nickel Leachability | Evaluate the nickel leachability of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis. | The nickel leachability of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, with the additional components, must be less than 290 ug/day during the first 24 hours and 29 ug/day during the duration of the 66 day testing. | PASS |
| Modular Component Separation Force | Evaluate the force required to separate components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis. | The individual force to separate the Branch Components and Distal Bifurcated Component from the Aortic Component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis must each be greater than or equal to the modular component separation force of the GORE® EXCLUDER® Iliac Branch Endoprosthesis with GORE® EXCLUDER® Contralateral Leg Endoprosthesis. | PASS |
| Acute Migration | Evaluate the ability of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis to remain at the target deployment location in a simulated use environment. | Acutely measured migration (longitudinal displacement from the initial deployment location) distance in-vitro must be within ±5 mm. | PASS |
| Sealing | Evaluate the ability of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis to seal an aneurysm in a simulated use environment for characterization purposes only. | The rate of fluid loss, due to the sealing of the device in the host vessel, the interface of the modular components, and the integral water permeability of the graft material will be characterized by junction. The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis normalized sealing value | Characterization |

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| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | | will be compared to the GORE® EXCLUDER® AAA Endoprosthesis sealing test results also normalized by the number of junctions under test. | |
| Branch Component Flow | Evaluate the flow rate through the Branch Components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis before and after device deployment for characterization purposes only. | Characterize the flow rate through the Branch Components before and after device deployment during simulated use testing. | Characterization |
| Pressure Drop | Evaluate the pressure drop for the components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in a simulated use environment. | In-vitro testing must demonstrate that the mean pressure drop across the Branch Components of an implanted GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis shall be less than 15 mmHg. | PASS |
| Deployment Accuracy for Optional DBC Extender Component | Measure the deployment accuracy of the optional DBC Extender Component in a simulated use environment. | The difference between the in-vitro target (intended) deployment site in the aneurysm model and the actual final proximal deployed location shall be measured and be within ± 5 mm of the desired target location. | PASS |
| Sealing of GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis with Optional DBC Extender Component | Evaluate the ability of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis with optional DBC Extender Component to seal an aneurysm in a simulated use environment for characterization purposes only. | The rate of fluid loss, due to the sealing of the device in the host vessel, the interface of the modular components, and the integral water permeability of the graft material will be characterized by junction. The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis normalized sealing value will be compared to the GORE® EXCLUDER® AAA Endoprosthesis sealing test results also normalized by the number of junctions under test. | Characterization |
| Branch Component Flow of GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis with Optional DBC Extender Component | Evaluate the flow rate through the Branch Components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis with optional DBC Extender Component before and after device deployment for characterization purposes only. | Characterize the flow rate through the Branch Components before and after device deployment during simulated use testing | Characterization |
| Pressure Drop of GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis with Optional DBC Extender Component | Evaluate the pressure drop for the components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in a simulated use environment. | In-vitro testing must demonstrate that the mean pressure drop across the Branch Components of an implanted GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis shall be less than 15 mmHg. | PASS |
| Durability Evaluation-Aortic Component to Distal Bifurcated Component Junction with Optional DBC Extender Component (Musculoskeletal-Induced Motion) | Evaluate the fatigue durability of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis for an implant duration equivalent to ten years. | The components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis will be durable to fatigue (physiologic motion/loading conditions) for an implantation duration equivalent to 10 years without damage that would compromise device function. | PASS |

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# B. Biocompatibility

Biocompatibility of the endoprosthesis and delivery system of Aortic Component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis was assessed in accordance with the requirements of EN ISO 10993-1.

The Aortic Component endoprosthesis is a medical device categorized by ISO 10933-1 as an implant with long-term exposure (>30 days) to circulating blood. The delivery system for the Aortic Component is categorized by ISO 10993-1 as an externally communicating device with limited exposure (<24 hours) to circulating blood.

All testing performed met the pre-specified acceptance criteria. A summary of the biocompatibility testing conducted for the Aortic Component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is provided in Table 5 for the endoprosthesis and Table 6 for the delivery system.

Table 5. Summary of GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Biocompatibility Testing (Aortic Component only)

| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Cytotoxicity | Determine the potential biological reactivity of a mammalian cell culture (L929) in response to the test article extract. | Test article extract cytotoxicity score is ≤ 2. | PASS |
| Sensitization | Determine the potential allergenic or sensitizing capacity of the test article. | Less than 10% of animals have a positive sensitization response. | PASS |
| Irritation / Intracutaneous Reactivity | Determine the potential irritation effects of the test article extract as a result of intracutaneous injections. | The difference in the average scores between test and control extracts is ≤ 1. | PASS |
| Acute Systemic Toxicity | Determine the potential toxic effects of the test article extract as a result of a single-dose systemic injection. | None of the animals treated with test extracts exhibit significantly greater biological reactions than control animals. | PASS |
| Material-Mediated Pyrogenicity | Determine the potential presence of chemical pyrogens in extracts of solid materials in order to limit to an acceptable level the risks of febrile reaction following administration of the product to the patient. | Temperature increases in individual animals treated with test article extract are each < 0.5°C. | PASS |
| Implantation Effects | Evaluate the test article for local tissue responses and the potential to induce local toxic effects after implantation in the muscle tissue. | Histological evaluation of implant sites, aided by gross observation at necropsy, indicate that tissue responses surrounding test article implants are not significantly greater than those associated with the negative control article. The Bioreactivity Rating should indicate no significant difference between test and control articles (≤ 2.9). | PASS |
| Hemocompatibility Hemolysis | Determine the potential hemolytic activity, via the induction of increased levels of free plasma hemoglobin in blood, in response to the test article and its extract. | Hemolytic index of test article must be < 5% above the negative control. | PASS |
| Hemocompatibility Partial Thromboplastin Time (PTT) Test | Determine the potential induction of coagulation of human plasma via measurement of the PTT in response to the test article. | No statistically significant difference between the clotting times of the test article and the untreated control or the negative control. | PASS |

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Table 6. Summary of GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Delivery System Biocompatibility Testing

| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Cytotoxicity | Determine the potential biological reactivity of a mammalian cell culture (L929) in response to the test article extract. | Test article extract cytotoxicity score is ≤ 2. | PASS |
| Sensitization | Determine the potential allergenic or sensitizing capacity of the test article. | Less than 10% of animals have a positive sensitization response. | PASS |
| Irritation / Intracutaneous Reactivity | Determine the potential irritation effects of the test article extract as a result of an intracutaneous injections. | The difference in the average scores between test and control extracts is ≤ 1. | PASS |
| Acute Systemic Toxicity | Determine the potential toxic effects of the test article extract as a result of a single-dose systemic injections. | None of the animals treated with test extracts exhibit significantly greater biological reactions than control animals. | PASS |
| Material-Mediated Pyrogenicity | Determine the potential presence of chemical pyrogens in extracts of solid materials in order to limit to an acceptable level the risks of febrile reaction following administration of the product to the patient. | Temperature increases in individual animals treated with test article extract are each < 0.5°C. | PASS |
| Hemocompatibility Hemolysis | Determine the potential hemolytic activity, via the induction of increased levels of free | Hemolytic index of test article must be < 5% above the negative control. | PASS |
| | cytotoxicity | in the presence of a high level of free cAMP. | |
| Hematopoietic Cell Line | Determine the potential immune response to the test article extract. | In the presence of a high level of free cAMP, the response to the test article extract is less than 10% of the normal. | PASS |
| Hematopoietic Cell Line | Determine the potential immune response to the test article extract. | In the presence of a high level of free cAMP, the response to the test article extract is less than 10% of the normal. | PASS |

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| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | plasma hemoglobin in blood, in response to the test article and its extract. | | |
| Hemocompatibility Complement | Determine the potential activation of the complement system in human plasma in response to the test article. | No statistically significant increase is found between the soluble complement SC5b-9 complex concentrations in the plasma exposed to test article and that of plasma exposed to either the negative control or the untreated control. | PASS |
| Hemocompatibility Partial Thromboplastin Time (PTT) Test | Determine the potential induction of coagulation of human plasma via measurement of the PTT in response to the test article. | No statistically significant difference between the clotting times of the test article and the untreated control or the negative control. | PASS |
| Hemocompatibility Thrombogenicity – Non-anticoagulated venous implant (NAVI) and Anticoagulated Venous Implant (AVI) | Compare materials intended for blood contact to each other in the same animal. The materials intended for blood contact were evaluated for thrombogenicity properties in-vivo. | The amount of thrombosis is considered comparable between the test article and the control device. | PASS¹ |

¹ The Aortic Component delivery system was considered non-thrombogenic under clinically relevant conditions using anticoagulants (AVI).

## C. Sterilization, Packaging and Shelf Life

The Aortic Component (endoprosthesis and delivery catheter) of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is sterilized by Ethylene Oxide (EO) to provide a Sterility Assurance Level (SAL) of 10⁻⁶. The EO sterilization cycles were validated in accordance with BS EN ISO 11135 Sterilization of health care products – Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices.

Packaging validation conducted for the Aortic Component demonstrated the ability of the packaging to protect the product and to maintain a sterile barrier through shipping and shelf life.

A shelf life of three (3) years was established for the Aortic Component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis based on product and package shelf life testing. The specific engineering tests completed to support the shelf life are denoted by an asterisk (*) in Table 4.

## X. SUMMARY OF PRIMARY CLINICAL STUDY

The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the U.S. and United Kingdom (U.K.) under IDE G150071. Data from this clinical study were the basis for the PMA approval decision. A summary of the clinical study is presented below.

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# A. Study Design

Patients were treated between July 8, 2019, and November 28, 2022. The database for this PMA reflected data collected through March 8, 2023, and included 102 Subjects meeting the clinical inclusion and exclusion criteria described below. There were 44 investigational sites (42 in the U.S. and 2 in the U.K.).

The study was a prospective, non-randomized, multicenter study. Enrollment was based on the extent of the aortic aneurysm and included Subjects with aneurysms that involved at least one visceral vessel. Specifically, TAAAs included those with a proximal extent which originated between the level of the superior mesenteric artery through as far as 65 mm proximal to the celiac artery. PAAAs included those with a proximal extent which originated at the level of the renal arteries, with no normal aorta between the upper extent of aneurysm and the renal artery(s), through as far proximally as the level of the superior mesenteric artery.

The study utilized two Co-Primary Endpoints:

- 30 day safety and effectiveness endpoint that is composite of Uncomplicated Technical Success and Procedural Safety, and
- 12 month safety and effectiveness endpoint that is composite of Clinically Significant Reintervention and Lesion-Related Mortality.

The 30 Day composite safety and effectiveness endpoint was defined as percentage of patients that achieve "uncomplicated technical success" and are free from "procedural safety" events through 30 days post index procedure. The results were tested against a performance goal of 80%, derived from open surgical repair literature available and experience from previous Gore aortic endovascular prostheses studies at the time of protocol development.

The 12 month composite safety and effectiveness endpoint was defined as percentage of patients that are free from "clinically significant reintervention" and "lesion-related mortality" through 12 months post index procedure. The results were tested against a performance goal of 68%, derived from experience of branched or fenestrated thoracoabdominal devices in the published literature available at the time of protocol development.

For each endpoint, a two-sided 90% Clopper-Pearson confidence interval (CI) was constructed (α = 0.05).

Evaluation groups were used during the pivotal study are described below:

- A Core Laboratory was used to perform independent assessments of computed tomography (CT)/computed tomography with angiography (CTA), X-Ray and duplex ultrasound (DUS) imaging submitted by clinical sites. The Core Laboratory assessments were used in final analyses.

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- An external Clinical Events Committee (CEC) adjudicated co-primary endpoint events and select adverse events and reviewed inclusion/exclusion violations for potential impact on Subject safety.
- An independent Data Safety Monitoring Board reviewed the data periodically to monitor the study for Subject safety.
- A Screening Committee provided a supplementary clinical review of medical history and imaging for all study candidates and provided a recommendation regarding whether the candidate should be included or excluded from the study.

1. Clinical Inclusion and Exclusion Criteria

Enrollment in the TAMBE Pivotal Study was limited to patients who met the following inclusion criteria:

- Aortic aneurysm involving the visceral vessel(s) requiring treatment defined as at least one of the following:
a) Fusiform aneurysm diameter ≥5 cm.
b) Saccular aneurysm (no diameter requirement).
c) Rapid aneurysm growth (≥5 mm in one year).

- Aortic aneurysm that involves the abdominal aorta, with:
a) Involvement of at least one visceral vessel and aneurysmal extension as far as 65 mm proximal to the celiac artery, and/or
b) No normal aorta between the upper extent of aneurysm and renal artery(s).

- Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required).
- Age ≥19 years at the time of informed consent signature.
- Male or infertile female.
- Subject assessment favors an endovascular approach when compared to open surgical repair, as deemed by the treating physician.
- Capable of complying with protocol requirements, including follow-up.
- An Informed Consent Form signed by Subject or legal representative.
- Sufficient distal landing zones in both iliac arteries, with at least one patent internal iliac artery and without planned placement of a branched iliac device, or planned coverage/occlusion/embolization of any patent internal iliac artery.
- Appropriate aortic anatomy to receive the TAMBE Device defined as all of the following:

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a) For the TAMBE Aortic Component, proximal aortic landing zone diameters between 22-34 mm.
b) Proximal seal zone ≥20 mm in length.
c) Aortic neck angle ≤60°.
d) Distal landing zone (iliac arteries) 8-25 mm.
e) Distal seal zone in iliac arteries of at least 10 mm in length.
f) Renal artery landing zone diameters between 4-10 mm.
g) Celiac and superior mesenteric artery landing zone diameters between 5-12 mm.
h) 15 mm landing zone in each branch vessel.
i) Visceral segment of aorta must be ≥20 mm in diameter.
j) Landing zones in the proximal and distal aorta and all branch vessels. cannot be aneurysmal, heavily calcified, or heavily thrombosed.
k) Patent left subclavian artery.

Patients were not permitted to enroll in the TAMBE Pivotal Study if they met any of the following exclusion criteria:

- Prior open, aortic surgery of the ascending aorta or aortic arch.
- Ruptured or leaking aortic aneurysm.
- Aneurysmal dilatation due to chronic aortic dissection.
- Infected aorta.
- Mycotic aneurysm.
- Life expectancy &lt;2 years.
- Myocardial infarction or stroke within 1 year of treatment (staged or index procedure).
- Systemic infection which may increase risk of endovascular graft infection.
- Degenerative connective tissue disease, e.g., Marfan’s or Ehlers-Danlos Syndrome.
- Participation in an investigational drug study (within 30 days of last administration) or investigational medical device study (within 1 year of implant) from the time of study screening.
- History of drug abuse, e.g., cocaine or amphetamine or alcohol, within 1 year of treatment.
- Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access.
- A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with device delivery or ability to exclude from blood flow.
- Known sensitivities or allergies to the device materials.

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- Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin.
- Subject has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta.
- Renal Insufficiency (creatinine value $&gt;1.8 \, \mathrm{mg/dL}$ , glomerular filtration rate (GFR) $&lt;30$ , or Subject undergoing dialysis).
- Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to require surgical intervention within one year of study treatment.

# 2. Follow-up Schedule

All patients were scheduled to return for follow-up examinations at 1, 3, 6, 12, 24, 36, 48, and 60 months. Table 7 outlines the required screening evaluations and follow-up visit procedures for Subjects.

Table 7. Evaluations and Post-Treatment Follow-Up Schedule

| | Pre-Treatment (Screening) | Treatment | Hospital Discharge | One Month | Three Months | Six Months | 1 Year then Annually through 5 Years |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Informed Consent | X | | | | | | |
| Demographics and Medical History | X | | | | | | |
| Risk Scales (ASA, NYHA, SVS)a | X | | | | | | |
| Physical examination | X | | X | X | X | X | X |
| Medication Review | X | | X | X | X | X | X |
| Modified Rankin Scaleb,c | X | | X | X | X If applicable | X | |
| Spinal Cord Ischemia Scaleb | X | | X | X | | X | |
| NIH Stroke Scaled | X | | X If applicable | | | | |
| SF-36 Questionnaire | X | | | X | X | X | X |
| Serum Creatinine Concentration | X | | X | X | X | X | X |
| Spiral CTA (contrast)e | X | | | X | | X | X |
| Spiral CT (non-contrast) | | | | X | | X Optional | X Optional |
| Completion Angiogram | | X | | | | | |
| Magnified Branch Visualization | | X | | | | | |
| Abdominal Ultrasound | X | | X | X | X | X | X |
| Multiplanar Device Radiographs (X-Ray) | | | | X | | X | X |

American Society of Anesthesiologists (ASA), New York Heart Association (NYHA), Society of Vascular Surgery (SVS)
b If Subject was unable to return to the site for a follow-up visit, they may be contacted by telephone to evaluate the Modified Rankin Scale (mRS) and Spinal Cord Ischemia Scale.
For Subjects suspected of having a stroke event within 30 days following the index endovascular procedure, an additional mRS score should be completed at 90 days following the suspected stroke event but no greater than 120 days post index endovascular procedure.

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National Institutes of Health (NIH) Stroke Scale should be performed for any Subject suspected of having a stroke event that undergoes the treating site’s stroke protocol during the study interval from the initiation of the index endovascular procedure until discharge. The scale should be performed as soon as possible after learning of the suspected event and again at the time of discharge.

CTA of chest/abdomen/pelvis at Screening. CTA of abdomen and pelvis was performed at all follow-up visits. Magnetic Resonance Angiogram (MRA) may be used in place of CTA during follow-up if the Subject was contraindicated for CTA.

Adverse events and complications were recorded at all visits.

The key timepoints are shown below in the tables summarizing safety and effectiveness.

# 3. Clinical Endpoints

The safety and effectiveness of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis was assessed through two independent co-primary endpoints:

1. 30 day safety and effectiveness endpoint that is a composite of Uncomplicated Technical Success and Procedural Safety,
2. 12 month safety and effectiveness endpoint that is a composite of Clinically Significant Reintervention and Lesion Related Mortality.

Co-Primary Endpoint #1 is a composite of the following events at two time points:

A. Uncomplicated technical success at the time of the index endovascular procedure:

i. Successful Access and Delivery
ii. Successful and Accurate Deployment
iii. Successful Withdrawal

B. Freedom from Procedural Safety events within the first 30 days of index procedure:

i. Stented Segment Aortic Rupture
ii. Lesion Related Mortality
iii. Permanent Paraplegia
iv. Permanent Paraparesis
v. New Onset renal Failure Requiring Dialysis
vi. Severe Bowel Ischemia
vii. Disabling Stroke

Co-Primary Endpoint #1 was compared to a Performance Goal (PG) of 80%.

Co-Primary Endpoint #2 is a composite of the following events through 12 months:

A. Clinically Significant Reintervention:

i. Clinically Indicated Condition
- Device Seal Zone Endoleak
- Lesion Growth &gt;5 mm
- Rupture

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ii. Device Effectiveness (Device Seal Zone / Integrity)
iii. Patient Safety Events (Total Occlusion of Device Component)
iv. Device System Prophylaxis (Reintervention requiring hospitalization)

B. Lesion-Related Mortality through 12 months

Co-Primary Endpoint #2 was compared to a PG of 68%.

With regard to success/failure criteria, the TAMBE Pivotal Study was considered to be successful if both the Co-Primary Endpoint Performance goals were met.

The following secondary endpoints were evaluated using descriptive statistics. Unless specified otherwise, the timeline for evaluation of these endpoints is through 12 months and annually thereafter through 5 years:

- Aneurysm-related mortality through 30 days
- Individual elements of Procedural Safety through 30 days
- Procedural blood loss during the index procedure
- Access-related complications through 30 days
- Procedure time
- Length of hospital stay following the index procedure
- Extended Technical Clinical Success through 30 days
- Individual elements of Clinically Significant Reintervention/Lesion-Related Mortality
- All Types of endoleaks
- Device migration
- TAAA enlargement, shrinkage and stability
- Please note that aneurysm shrinkage and stability were not protocol-defined secondary endpoints, but they were also evaluated
- Severe distal thromboembolic events
- Aortic rupture
- Device or procedure-related laparotomy
- Conversion to open repair
- Aortoiliac device limb occlusion
- Loss of device integrity
- All reinterventions
- Branch vessel patency
- Acute kidney injury through 30 days
- Renal function deterioration

B. Accountability of PMA Cohort

At the time of database lock, 102 Subjects meeting the above inclusion and exclusion criteria were eligible and included for analysis. Information regarding Subject disposition and imaging assessment by analysis windows is provided in Table 8.

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Table 8. Subject Disposition and Imaging Assessments by Analysis Windows

| | Patient Follow-Up | | | Imaging Performed1 | | | | Imaging Adequate to Assess the Parameter | | | | | Subject Status | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Analysis Windows1 | Eligible for Follow-Up2 | Subjects with Any Visit in Analysis Window2 | No Visit, Still in Analysis Window | CT Scan | MRA | X-Ray | Ultrasound | Aneurysm Size | Endoleak | Migration | Fracture | Patency | Death | Lost To Follow Up (LTFU)/ Withdrawal/ Discontinuation | Not Due for Next Visit |
| Procedure | 102 | - | - | - | - | - | - | - | - | - | - | - | 0 | 0 | 0 |
| Post-Procedure | 102 | 96 (94.1%) | 0 (0.0%) | 23 (22.5%) | 0 (0.0%) | 15 (14.7%) | 95 (93.1%) | 23 (22.5%) | 21 (20.6%) | 23 (22.5%) | 27 (26.5%) | 92 (90.2%) | 0 | 0 | 0 |
| 1 Month | 102 | 97 (95.1%) | 0 (0.0%) | 96 (94.1%) | 0 (0.0%) | 94 (92.2%) | 94 (92.2%) | 96 (94.1%) | 92 (90.2%) | 96 (94.1%) | 94 (92.2%) | 95 (93.1%) | 1 | 0 | 0 |
| 3 Months | 101 | 82 (81.2%) | 0 (0.0%) | 14 (13.9%) | 0 (0.0%) | 10 (9.9%) | 76 (75.2%) | 14 (13.9%) | 13 (12.9%) | 14 (13.9%) | 16 (15.8%) | 78 (77.2%) | 4 | 1 | 0 |
| 6 Months | 96 | 81 (84.4%) | 0 (0.0%) | 75 (78.1%) | 0 (0.0%) | 70 (72.9%) | 77 (80.2%) | 75 (78.1%) | 72 (75.0%) | 72 (75.0%) | 72 (75.0%) | 81 (84.4%) | 0 | 0 | 0 |
| 12 Months | 96 | 88 (91.7%) | 14 (1.0%) | 87 (90.6%) | 1 (1.0%) | 80 (83.3%) | 81 (84.4%) | 87 (90.6%) | 81 (84.4%) | 87 (90.6%) | 83 (86.5%) | 86 (89.6%) | 3 | 3 | 11 |
| 24 Months | 79 | 42 (53.2%) | 34 (43.0%) | 42 (53.2%) | 0 (0.0%) | 38 (48.1%) | 37 (46.8%) | 42 (53.2%) | 37 (46.8%) | 41 (51.9%) | 37 (46.8%) | 42 (53.2%) | 1 | 3 | 43 |
| 36 Months | 32 | 13 (40.6%) | 19 (59.4%) | 11 (34.4%) | 0 (0.0%) | 12 (37.5%) | 12 (37.5%) | 11 (34.4%) | 9 (28.1%) | 11 (34.4%) | 12 (37.5%) | 12 (37.5%) | 2 | 0 | 24 |
| 48 Months | 6 | 0 (0.0%) | 6 (100.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 | 0 | 6 |
| 60 Months | 0 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |

Study period definitions: Procedure (day 0); Post-Procedure (1-14 days); 1 Month (15-59 days); 3 Months (60-126 days); 6 Months (127-242 days); 12 Months (243-546 days); 24 Months (547-911 days); 36 Months (912-1275 days); 48 Months (1276-1640 days); and 60 Months (1641-2006 days).
2 Any visit consisting of physical exam, spiral CTA, spiral CT, abdominal ultrasound, X-Ray Percentages are based on number of subjects eligible for follow-up in analysis windows.
3 At 1 Month, required imaging includes spiral CTA, spiral CT, abdominal Ultrasound, and X-Ray. At 3 Months, required imaging includes only abdominal ultrasound. For subsequent time periods, required imaging includes: spiral CTA, abdominal ultrasound, and X-Ray. MRA may be used in place of CTA during follow-up if the Subject is contraindicated for CTA.
4 At the time of data export, one Subject had not completed their 12-month visit; however, remained within the analysis window. Subject was deemed to be lost to follow up.
5 Eligible for Follow-Up includes Subjects who had not been in-eligible for future visits and are due for the follow-up visit.

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## C. Study Population Demographics and Baseline Parameters

### Demographics

The demographics of the study population are typical for an endovascular graft study performed in the U.S. for the treatment of complex aneurysms involving the visceral aorta.

A summary of Subject demographics is provided in Table 9. The majority of Subjects were male (84/102; 82.4%). The majority of Subjects were Not Hispanic or Latino (92/99; 92.9%). The majority of Subjects were White (86/99; 86.9%). The median age was 73.0 years old (range 58-89 years). Median Body Mass Index (BMI) was 27.6 kg/m².

Table 9. Summary of Baseline Demographic Characteristics of Implanted Subjects

| Number of Subjects | 102 |
| --- | --- |
| | |
| Sex at Birth | 102 |
| Male | 84 (82.4%) |
| Female | 18 (17.6%) |
| | |
| Ethnicity (U.S. Only)^{1} | 99 |
| Not Hispanic or Latino | 92 (92.9%) |
| Hispanic or Latino | 2 (2.0%) |
| Unknown or Not Reported | 5 (5.1%) |
| | |
| | |
| Race (U.S. Only)^{1} | 99 |
| White | 86 (86.9%) |
| Black or African American | 4 (4.0%) |
| Asian | 2 (2.0%) |
| American Indian or Alaska Native | 2 (2.0%) |
| Hawaiian or Pacific Islander | 1 (1.0%) |
| Other | 5 (5.1%) |
| | |
| Age (years) | |
| n | 102 |
| Mean (Std Dev) | 73.3 (6.39) |
| Median | 73.0 |
| Range | (58.0, 89.0) |
| | |
| Weight (kg) | |
| n | 102 |
| Mean (Std Dev) | 88.1 (18.37) |
| Median | 86.7 |
| Range | (42.0, 142.9) |
| | |
| Height (cm) | |
| n | 102 |
| Mean (Std Dev) | 176.2 (9.18) |

{25}

| Median | 177.4 |
| --- | --- |
| Range | (149.9, 193.0) |
| | |
| BMI (kg/m2) | |
| n | 102 |
| Mean (Std Dev) | 28.3 (5.01) |
| Median | 27.6 |
| Range | (17.0, 46.5) |

1 Race and ethnicity data was not collected for Subjects outside of the U.S. $(n = 3)$

# Subject Baseline Medical History

A summary of the Subject baseline medical history is provided in Table 10.

Table 10. Summary of Subject Baseline Medical History

| Number of Subjects | 102 |
| --- | --- |
| | |
| Atrial Fibrillation | 18 (17.6%) |
| Cancer | 29 (28.4%) |
| Cardiac Arrhythmia | 16 (15.7%) |
| Chronic Obstructive Pulmonary Disease | 27 (26.5%) |
| Congestive Heart Failure | 8 (7.8%) |
| Coronary Artery Bypass Graft | 23 (22.5%) |
| Coronary Artery Disease | 50 (49.0%) |
| Diabetes Mellitus | 24 (23.5%) |
| Erectile Dysfunction (% of Male) | 10 (11.9%) |
| Familial History of Aneurysms | 17 (16.7%) |
| Familial History of Atherosclerosis | 16 (15.7%) |
| Hypercholesterolemia | 86 (84.3%) |
| Hypertension | 94 (92.2%) |
| Myocardial Infarction | 26 (25.5%) |
| Other Vascular Intervention | 9 (8.8%) |
| Paraplegia | 0 (0.0%) |
| Percutaneous Coronary Intervention | 22 (21.6%) |
| Peripheral Vascular Disease | 13 (12.7%) |
| Renal Dialysis | 0 (0.0%) |
| Renal Insufficiency | 11 (10.8%) |
| Stroke | 5 (4.9%) |
| Thrombocytopenia | 1 (1.0%) |
| Thromboembolic Event | 3 (2.9%) |
| Transient Ischemic Attack (TIA) | 2 (2.0%) |
| Valvular Heart Disease | 6 (5.9%) |
| Visceral Artery Stenosis | 2 (2.0%) |
| | |
| Previous Aortic Surgery | 5 (4.9%) |
| Ascending Aorta | 0 (0.0%) |
| Aortic Arch | 0 (0.0%) |
| Descending Thoracic Aorta (DTA) (not involving proximal landing zone) | 0 (0.0%) |
| Abdominal Aorta | 5 (4.9%)1 |

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One of the five Subjects with previous abdominal aorta surgery had previous abdominal aortic aneurysm surgery reported in the Electronic Data Capture System (EDC); however, Site confirmed this was a data entry error after data export. The remaining four Subjects were prior open repairs. In all cases, the TAMBE Device seal zone was within the native aorta.

# Pre-Treatment Baseline Risk Factors

A summary of pre-treatment risk factors is provided in Table 11.

Table 11. Summary of Baseline Risk Factors

| Number of Subjects | 102 |
| --- | --- |
| | |
| Diabetes | |
| None | 81 (79.4%) |
| Adult Onset, Diet-Controlled | 16 (15.7%) |
| Adult Onset, Insulin-Controlled | 5 (4.9%) |
| Juvenile Onset | 0 (0.0%) |
| | |
| Tobacco Use | |
| None or None in last 10 Years | 39 (38.2%) |
| None currently, but smoked in last 10 Years | 20 (19.6%) |
| Current, Less than 1 pack/day | 30 (29.4%) |
| Current, Greater than 1 pack/day | 13 (12.7%) |
| | |
| Hypertension | |
| None | 9 (8.8%) |
| Controlled with Single Drug | 35 (34.3%) |
| Controlled with 2 Drugs | 40 (39.2%) |
| Requires more than 2 drugs or Uncontrolled | 18 (17.6%) |
| | |
| Hyperlipidemia | |
| Cholesterol/triglycerides within normal limits for age | 17 (16.7%) |
| Mild Elevation, controllable by Diet | 23 (22.5%) |
| Types II, III, or IV, requiring strict dietary control | 3 (2.9%) |
| Dietary and Drug Control | 59 (57.8%) |
| | |
| Cardiac Status | |
| Asymptomatic, normal electrocardiogram | 63 (61.8%) |
| Asymptomatic, h/o MI >6 or occult MI by ECG | 28 (27.5%) |
| Stable Angina | 11 (10.8%) |
| Unstable Angina | 0 (0.0%) |
| | |
| Carotid Status | |
| No symptoms, bruit, or evidence of disease | 88 (86.3%) |
| Asymptomatic, but with evidence of disease | 12 (11.8%) |
| Transient or Temporary Stroke | 2 (2.0%) |
| Complete Stroke with Permanent Neurologic Deficit | 0 (0.0%) |
| | |
| Renal Status | |
| Creatinine less than 1.5mg/dl, Clearance >50ml/min | 96 (94.1%) |

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Device Usage

PMA P230023: FDA Summary of Safety and Effectiveness Data

| 1.5 - 3.0 mg/dl Creatinine, Clearance 30 - 50 ml/min | 6 (5.9%) |
| --- | --- |
| 3.0 - 6.0 mg/dl Creatinine, Clearance 15 - 30 ml/min | 0 (0.0%) |
| Creatinine greater than 6.0 ml/dl, Clearance < 15 ml/min | 0 (0.0%) |
| | |
| **Pulmonary Status** | |
| 0 - Asymptomatic, normal chest X-Ray | 81 (79.4%) |
| 1 - Asymptomatic or mild dyspnea or exertion, mild X-Ray parenchymal changes, PFTs 65%-80% of predicted | 18 (17.6%) |
| 2 - Between 1 and 3 | 3 (2.9%) |
| 3 - Vital capacity < 1.85 L, Forced Expiratory Volume (FEV_{1}) less than 1.2 L or less than 35% of predicted, Maximal Voluntary Ventilation less than 50% of predicted, pCO_{2} greater than 45 mm/Hg. Supplemental oxygen use medically necessary, or Pulmonary Hypertension (HTN) | 0 (0.0%) |

¹ Categorization per Society of Vascular Surgery (SVS) Reporting Standards¹.

## Pre-Treatment Aneurysm Size and Type

A summary of pre-treatment aneurysm size and type is displayed in Table 12. Aneurysm size represents site-reported data and aneurysm type represents the joint assessment by Gore Imaging Services and a Screening Committee comprised of consulting physicians.

Table 12. Breakdown of Pre-Index Procedure Aneurysm Size and Type

| Number of Subjects | 102 |
| --- | --- |
| | |
| Aneurysm Size¹ - Type IV² | 59 (57.8%) |
| <5.0 cm | 0 |
| 5.00-5.49 cm | 10/59 (16.9%) |
| 5.50-5.99 cm | 27/59 (45.8%) |
| ≥6.0 cm | 22/59 (37.3%) |
| | |
| Aneurysm Size¹ - Pararenal² | 43 (42.2%) |
| <5.0 cm | 1/43 (2.3%)³ |
| 5.00-5.49 cm | 11/43 (25.6%) |
| 5.50-5.99 cm | 16/43 (37.2%) |
| ≥6.0 cm | 15/43 (34.9%) |

¹ Pre-index procedure aneurysm size was determined by the Site’s baseline measurement.
² Aneurysm type was determined via centralized review consisting of Gore Imaging Sciences and physician(s) with prior TAMBE Device experience.
³ Saccular aneurysm. Per Principal Investigator (PI), urgent repair was needed due to unpredictability of the natural history of saccular aneurysms.

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Table 13 summarizes the devices each Subject received during the index treatment procedure.

On average, a Subject was implanted with a total of 11 devices including 1 TAMBE Aortic Component, 7 Branch Components, 1 Distal Bifurcated Component, and 2 contralateral leg endoprostheses or iliac extenders. Forty-seven Subjects (47/102; 46.1%) received a 31 mm Aortic Component and 55 Subjects (55/102; 53.9%) received a 37 mm Aortic Component. Of all 656 Branch Components implanted, the most commonly implanted sizes [presented as diameter (mm) x length (mm)] were the following: 7 mm x 79 mm (167/656; 25.5%), 7 mm x 59 mm (81/656; 12.3%), 9 mm x 59 mm (70/656; 10.7%), and 6 mm x 79 mm (64/656; 9.8%).

Table 13. Summary of Implanted Devices

| | Index Procedure |
| --- | --- |
| Number of Subjects with Devices Implanted | 102 |
| | |
| Subjects with TAMBE Aortic Component | 102 (100.0%) |
| 1 Device | 102 (100.0%) |
| | |
| TAMBE Aortic Component Proximal Diameter (mm) x Distal Diameter (mm) x Length (mm) | |
| 31 x 20 x 160 | 47 (46.1%) |
| 37 x 20 x 160 | 55 (53.9%) |
| | |
| Subjects with Branch Components | 102 (100.0%) |
| Celiac | 102 (100.0%) |
| 1 Device | 59 (57.8%) |
| 2 Devices | 42 (41.2%) |
| 3 Devices | 1 (1.0%) |
| SMA | 102 (100.0%) |
| 1 Device | 50 (49.0%) |
| 2 Devices | 50 (49.0%) |
| 3 Devices | 2 (2.0%) |
| Left Renal | 102 (100.0%) |
| 1 Device | 30 (29.4%) |
| 2 Devices | 60 (58.8%) |
| 3 Devices | 11 (10.8%) |
| 4 Devices | 1 (1.0%) |
| Right Renal | 102 (100.0%) |
| 1 Device | 38 (37.3%) |
| 2 Devices | 64 (62.7%) |
| 3 Devices | |
| Other^{1} | 1 (1.0%) |
| 1 Device | 1 (1.0%) |
| | |
| Subjects with Distal Bifurcated Component | 102 (100.0%) |
| 1 Device | 102 (100.0%) |
| | |
| Subjects with Contralateral Leg Endoprosthesis/Iliac Extender | 102 (100.0%) |
| 2 Devices | 53 (52.0%) |

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| | Index Procedure |
| --- | --- |
| 3 Devices | 36 (35.3%) |
| 4 Devices | 11 (10.8%) |
| 5 Devices^{2} | 1 (1.0%) |
| 6 Devices^{3} | 1 (1.0%) |
| | |
| Subjects with GORE® TAG® Conformable Thoracic Endoprosthesis^{4} | 4 (3.9%) |
| 1 Device | 4 (3.9%) |
| | |
| Subjects with Other Device^{5} | 23 (22.5%) |
| 1 Device | 16 (15.7%) |
| 2 Devices | 4 (3.9%) |
| 3 Devices | 1 (1.0%) |
| 4 Devices | 1 (1.0%) |
| 5 Devices | 1 (1.0%) |

1. Subject received one Branch Component in the left hepatic artery for treatment of a focal dissection.
2. One Subject received 5 contralateral leg endoprosthesis/iliac extenders during the index procedure to achieve adequate coverage and overlap. Completion angiogram revealed the presence of a dissection of the left common iliac artery from the aortic bifurcation to the iliac bifurcation. This dissection was completely covered by the contralateral leg endoprosthesis/iliac extenders.
3. One Subject received 6 contralateral leg endoprosthesis/iliac extenders in total during the index procedure to allow for appropriate bridging of devices to resolve a Type III endoleak detected after the completion aortogram was performed. The additional two iliac limbs implanted resolved the endoleak.⁴ GORE® TAG® Conformable Thoracic Endoprosthesis were successfully implanted during the index treatment procedure in four Subjects as proximal extensions to treat intraoperative Type I endoleak or iatrogenic dissection. Use of these devices was not planned.
4. Other devices successfully implanted during the index treatment procedure included aortic extenders, bare metal stents, embolization coils, one self-expanding stent graft and one bovine pericardial patch.

## Procedure Characteristics

A summary of procedure data collected at the time of the index treatment procedure is provided in Table 14. All Subjects (100%) survived the index procedure.

The median procedure time was 302.5 minutes (range 163-944 min) with a median anesthesia time of 419.5 minutes (range 250-1175 min). Median procedural blood loss was 250 ml (range 10-2000 ml). Four Subjects experienced ≥ 1000 ml of procedural blood loss, three of whom received a transfusion. Procedural time for these Subjects ranged from 287-531 minutes. Of the neurological protection strategies tracked within the study database, 90 Subjects (90/102; 88.2%) had at least one strategy used during the TAMBE Device index procedure. Elevated mean arterial pressure was the most common protection strategy used (49/102; 48%), and electromyography (EMG) the least used protection strategy, (2/102; 2.0%). A prophylactic Cerebrospinal fluid (CSF) drain was placed in 9.8% of Subjects (10/102).

Table 14. Summary of TAMBE Device Index Procedure

| | Index Procedure |
| --- | --- |
| Number of Subjects | 102 |
| | |
| Procedure Time (minutes) | |

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| | Index Procedure |
| --- | --- |
| Mean (Std Dev) | 315.3 (103.3) |
| Median | 302.5 |
| Range | (163, 944^{1}) |
| | |
| **Anesthesia Type** | |
| General | 102 (100.0%) |
| | |
| **Anesthesia Time (minutes)** | |
| Mean (Std Dev) | 438.4 (117.0) |
| Median | 419.5 |
| Range | (250, 1175) |
| | |
| **Access Method - Right Femoral** | |
| Percutaneous | 90 (88.2%) |
| Cut-down | 9 (8.8%) |
| Cut-down and conduit | 3 (2.9%) |
| Not Used | 0 (0.0%) |
| | |
| **Access Method - Left Femoral** | |
| Percutaneous | 90 (88.2%) |
| Cut-down | 11 (10.8%) |
| Cut-down and conduit | 1 (1.0%) |
| Not Used | 0 (0.0%) |
| | |
| **Access Method - Right Arm** | |
| Percutaneous | 2 (2.0%) |
| Cut-down | 40 (39.2%) |
| Cut-down and conduit | 1 (1.0%) |
| Not Used | 59 (57.8%) |
| | |
| **Access Method - Left Arm** | |
| Percutaneous | 5 (4.9%) |
| Cut-down | 49 (48.0%) |
| Cut-down and conduit | 5 (4.9%) |
| Not Used | 43 (42.2%) |
| | |
| **Side Aortic Component Delivered** | |
| Left | 26 (25.5%) |
| Right | 76 (74.5%) |
| | |
| **Time Between Aortic Component (AC) Insertion to Final Completion Angiogram (minutes)** | |
| n | 98^{2} |
| Mean (Std Dev) | 189.2 (81.18) |
| Median | 173.0 |
| Range | (59, 690) |
| | |
| **Neurological Protection Strategies Used^{3}** | 90 (88.2%) |
| CSF Drain | 10 (9.8%) |

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| | Index Procedure |
| --- | --- |
| MEP/SSEP | 29 (28.4%) |
| NIRS | 22 (21.6%) |
| Steroid | 15 (14.7%) |
| Elevated Mean Arterial Pressure | 49 (48.0%) |
| Hypothermia | 4 (3.9%) |
| ECG | 46 (45.1%) |
| EMG | 2 (2.0%) |
| | |
| **Total Fluoroscopic Time (minutes)** | |
| Mean (Std Dev) | 80.8 (35.85) |
| Median | 74.5 |
| Range | (29, 249) |
| | |
| **Contrast Used During Procedure (mL)** | |
| Mean (Std Dev) | 153.6 (73.56) |
| Median | 143.0 |
| Range | (16, 420) |
| | |
| **Total Radiation Dose (Gy cm²)** | |
| n | 95^{4} |
| Median | 250.0 |
| Interquartile Range (IQR) | 150.0, 626.0 |
| | |
| **Estimated Blood Loss During Procedure (mL)** | |
| Mean (Std Dev) | 299.9 (295.5) |
| Median | 250.0 |
| Range | (10, 2000) |
| | |
| **Transfusion Required** | 14 (13.7%) |
| | |
| **Heparin Administered** | 102 (100.0%) |
| | |
| **Additional Procedures Performed** | 32 (31.4%)^{8} |
| Planned Additional Procedures | 6 (5.9%) |
| Unplanned Additional Procedures | 28 (27.5%) |
| | |
| **Subject Survived Procedure** | 102 (100.0%) |

1. One Subject had a prolonged procedure time due to challenges with cannulation of visceral vessels and additional time spent for observation of renal outflow.
2. Missing three Subjects due to time values for completion angiogram not being provided. Missing one subject who has a negative time value and was not counted and considered a data entry error.
3. The neurological protection strategies in the table are not an exhaustive list, but only includes those captured in the study database; Cerebrospinal fluid (CSF) drain, motor/ somatosensory-evoked potential (MEP / SSEP) monitoring, Near-infrared spectroscopy (NIRS) monitoring, Steroid, Elevated Mean Arterial Pressure (MAP), Hypothermia, Electrocardiogram (ECG), and Electromyography (EMG).
4. Data was based on site's calculation. Total Radiation Dose was not collected for six Subjects. For one subject, data entry field would not accept decimal; therefore, the value was rounded down to 0 and this was excluded from this analysis.
5. This was done on a per-subject level. Two Subjects had both a planned and an unplanned procedure. These included placement of a self-expanding GORE® VIABAHN® Endoprosthesis in the left subclavian artery after extravasation of contrast visualized, prophylactic coil embolization, use of Aortic Extender to treat Type III endoleaks at the junction of Distal Bifurcated Component and the Aortic Component, use of CTAG for treatment of intraoperative Type I endoleak and iatrogenic dissections, use of bare metal stents to address iatrogenic dissection and smoothing a transition zone, use of bovine pericardial patch to

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treat focal dissection, and other procedures that did not require device implantation (e.g., thrombectomy, Percutaneous Transluminal Angioplasty).

Table 15 summarizes hospital discharge details. The median length of hospital stay after the index procedure was four days with a range of 1-19 days. Ninety-one Subjects (91/102; $89.2\%$ ) were discharged home. No Subject required long-term rehabilitation.

Table 15. Summary of Index Treatment Procedure Discharge Details

| Number of Subjects | 102 |
| --- | --- |
| | |
| Time in ICU (hours) | 83 |
| Mean (Std Dev) | 58.7 (52.72) |
| Median | 48.0 |
| Range | (1, 288) |
| | |
| Length of Stay for TAMBE Device Procedure (days) | 102 |
| Mean (Std Dev) | 4.9 (3.45) |
| Median | 4.0 |
| Range | (1, 19) |
| | |
| Time on Ventilator (hours) | 102 |
| Mean (Std Dev) | 8.9 (11.43) |
| Median | 7.0 |
| Range | (2, 99) |
| | |
| Post Procedure Location | 102 |
| Post Anesthesia Recovery Unit | 21 (20.6%) |
| ICU | 69 (67.6%) |
| Step Down Unit | 1 (1.0%) |
| Medical Ward (Floor) | 10 (9.8%) |
| Other | 1 (1.0%) |
| | |
| Discharge Location | 102 |
| Home | 91 (89.2%) |
| Skilled Nursing | 4 (3.9%) |
| Short Term Rehab | 6 (5.9%) |
| Long Term Rehab | 0 |
| Other | 1 (1.0%) |

# D. Safety and Effectiveness Results

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The analyses were hypothesis-driven. The safety and effectiveness of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis was assessed through two independent composite co-primary endpoints:

1. 30 day safety and effectiveness endpoint that is a composite of Uncomplicated Technical Success and/ Procedural Safety,
2. 12 month safety and effectiveness endpoint that is a composite of Clinically Significant Reintervention and Lesion Related Mortality.

Co-Primary Endpoint #1 is a composite of the following events at two time points:

A. Uncomplicated technical success at the time of the index endovascular procedure:
i. Successful Access and Delivery
ii. Successful and Accurate Deployment
iii. Successful Withdrawal

B. Freedom from Procedural Safety events within the first 30 days of index procedure:
i. Stented Segment Aortic Rupture
ii. Lesion Related Mortality
iii. Permanent Paraplegia
iv. Permanent Paraparesis
v. New Onset renal Failure Requiring Dialysis
vi. Severe Bowel Ischemia
vii. Disabling Stroke

Co-Primary Endpoint #2 is a composite of the following events through 12 months:

A. Clinically Significant Reintervention
i. Clinically Indicated Condition
- Device Seal Zone Endoleak
- Lesion Growth &gt;5 mm
- Rupture
ii. Device Effectiveness (Device Seal Zone / Integrity)
iii. Patient Safety Events (Total Occlusion of Device Component)
iv. Device System Prophylaxis (Reintervention requiring hospitalization)

B. Lesion-Related Mortality through 12 months

1. Co-Primary Endpoint #1: 30 Day Safety and Effectiveness Endpoint

Table 16 displays the Composite 30 Day Safety and Effectiveness Primary Endpoint and 90% confidence interval (CI). Subgroup analysis for the endpoint results was performed by Subject’s sex, aneurysm t…