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	ATAA43120160A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported through the aaa 24-01 tambe post approval study: on (b)(6) 2025, the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) device system.It was noted that the patient's left renal artery was coil embolized as planned due to preexisting occlusion, and no gore devices were implanted in the left renal artery.On final completion angiography, a type iii general endoleak was observed from the left renal artery portal where the amplatz plugs were utilized as planned.On (b)(6) 2025, a reintervention was performed to treat the type iii endoleak.Cannulation of the left renal portal was attempted but was unsuccessful after numerous attempts.The procedure was terminated and the endoleak is ongoing.
Additional Manufacturer Narrative
H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.According to the gore® excluder® thoracoabdominal branch endoprosthesis instructions for use, potential device and procedure-related adverse events and complications that may occur with the use of the gore® excluder® thoracoabdominal branch endoprosthesis, or in any endovascular repair procedure, which may or may not require intervention include, but are not limited to, endoleak.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.
Additional Manufacturer Narrative
H.6.Medical device problem: code a0502 updated to code a2303.H.6.Investigation conclusions: code d1002 updated to code d1103.H.6.Investigation conclusions: code d12 remains unchanged.According to the gore® excluder® thoracoabdominal branch endoprosthesis instructions for use (ifu), potential device and procedure-related adverse events and complications that may occur with the use of the gore® excluder® thoracoabdominal branch endoprosthesis, or in any endovascular repair procedure, which may or may not require intervention include, but are not limited to, endoleak.Additionally, the ifu states that the 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, celiac artery, and renal arteries are perfused via four antegrade portals in the aortic component.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22349543
• Report Number: 2017233-2025-06364
• Device Sequence Number: 20026759
• Product Code: QZK
• UDI-Device Identifier: 00733132659678
• UDI-Public: (01)00733132659678(17)270520
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 07/28/2025

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: ATAA43120160A
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White