MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS; ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO

Catalog Number	ATAA43720160A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient referenced in this event file is enrolled in the aaa24-01 tambe post approval study and information regarding this event was gathered from the imedidata clinical database.On (b)(6) 2025, the patient underwent endovascular treatment of a type iv thoracoabdominal aortic aneurysm.The patient was treated with a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) and a gore® excluder® aaa endoprosthesis contralateral leg.It was reported that on (b)(6) 2026, the patient was diagnosed with a contained rupture of the perivisceral abdominal aortic aneurysm.The physician reintervened on (b)(6) 2026, endovascular repair of the left common iliac artery aneurysm with a left iliac extension into the left external iliac artery.The left hypogastric artery was coil embolized.There was an aortic cuff implanted proximally to the tambe device to overlap this region to prevent a possible junctional endoleak.The patient tolerated the procedure.Reportedly on (b)(6) 2026 patient developed acute kidney failure, the event is ongoing.
Additional Manufacturer Narrative
W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS
• Common Device Name: ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24682803
• Report Number: 2017233-2026-07294
• Device Sequence Number: 9903061
• Product Code: QZK
• UDI-Device Identifier: 00733132659685
• UDI-Public: (01)00733132659685(17)280308
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P230023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ATAA43720160A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 115 KG