MAUDE Adverse Event Report: W. L. Gore & Associates, Inc. GORE® EXCLUDER® Conformable AAA Endoprosthesis; System, Endovascular Graft, Aortic Aneurysm Treatment

Catalog Number	CXA280005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2026
Type of Reportable Event	Death
Event or Problem Description
The following information was reported to gore: on (b)(6) 2026, a patient underwent an emergency endovascular procedure to treat a ruptured abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis system devices and gore® excluder® conformable aaa endoprosthesis devices.The endovascular procedure itself was completed, and the patient tolerated the procedure.After the endovascular procedure, open surgery was performed for decompression and removal of the hematoma.During the open surgery, the right leg was reported to possibly be disconnected from the right common iliac artery.The physician tried to extend the stent graft to the external iliac artery; however, the patient's condition suddenly took a turn for the worse, and the patient died.The most distal device of the right leg was the aortic extender.Gore fsa was not present at the procedure.No comment was obtained from the physician regarding a causal relationship between the device and the patient¿s death.
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device could not be performed as a valid lot number was not provided.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® Conformable AAA Endoprosthesis
• Common Device Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Manufacturer (Section D): W. L. Gore & Associates, Inc.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): Medical Silicon Valley B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: mana yamamoto ; 1505 n. fourth street; flagstaff, AZ 86004 ; +1(928)526-3030
• MDR Report Key: 50125657
• Report Number: 3013164176-2026-03165
• Device Sequence Number: 20243093
• Product Code: MIH
• UDI-Device Identifier: 00733132650958
• UDI-Public: (01)00733132650958(17)290328
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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: CXA280005
• 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: 07/22/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2026
• 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: Death
• Patient Age: 74 YR
• Patient Sex: Male