MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RLT231412
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Ischemia (1942); Obstruction/Occlusion (2422)
Date of Event	03/07/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.As part of our routine quality procedures, each batch of devices undergoes comprehensive quality control testing and inspections prior to release for distribution.Gore reviewed the manufacturing records associated with the reported lot number and verified that all release criteria had been met.The primary reported device failure mode, collapse or compression of the excluder c3 device ipsilateral leg within nine days of initial implant, is consistent with evaluation of the provided clinical images.The imaging evaluation shows compression and occlusion of the endoprosthesis, but the imaging is unable to confirm the report of contrast outside the endoprosthesis.The imaging evaluation indicates the patient¿s aorta is tortuous near the renal arteries, but the specific cause for the device collapse could not be established with the available information.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.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.
Event or Problem Description
It was reported to gore that a gore® excluder® aaa endoprosthesis and a gore® excluder® iliac branch endoprosthesis was implanted on (b)(6) 2025 during an endovascular procedure on a patient with an abdominal aortic aneurysm associated with a right common iliac aneurysm.During the procedure the final angiography showed a perfect result with no delay of the contrast product and good arterial pulses on both axes.9 days post-implant, on (b)(6) 2025, the patient was admitted in emergency for acute ischemia.The ct scan shows that the gore® excluder® aaa endoprosthesis has completely collapsed and the contrast passing outside the endoprosthesis.The patient underwent a surgery for an axillary bifemoral bypass.The patient past away 2 days later from ischemia syndromes.
Additional Manufacturer Narrative
Corrected h6: added type of investigation code b20.Code b13 and b17 was inadvertently entered and should be removed.Updated investigation findings code to c24, code c21 is no longer applicable.Updated investigation conclusions code to d15, code d16 is no longer applicable.

• Brand Name: GORE® EXCLUDER® 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21751148
• Report Number: 3007284313-2025-03874
• Device Sequence Number: 8236059
• Product Code: MIH
• UDI-Device Identifier: 00733132622368
• UDI-Public: (01)00733132622368(17)271203
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RLT231412
• 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: 03/09/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Male