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

Catalog Number	PXT231414
Medical Device Problem Codes	Migration (4003); Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 cfr 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
The following was reported to gore: in 2006, a patient was treated for an abdominal aortic aneurysm using a gore®excluder®aaa endoprosthesis.In (b)(6) 2025, the patient had a fall.During a ct scan at the hospital, it was noticed that the patient had a type 1a endoleak.On (b)(6) 2025, the patient had a reintervention, with a proximal cuff extension being placed.This successfully resolved the type 1a endoleak.The patient tolerated the procedure.Reportedly, the physician believes the graft may have migrated, as the proximal end of the graft is 1cm distal to the renal arteries; and that the potential migration may be caused by degeneration of the proximal neck.However, this remains unknown.
Additional Manufacturer Narrative
H6: type of investigation code b20: the device remains implanted and is not available for analysis.H6: investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: type of investigation code b15: the reported failure mode, potential migration observed approximately 19 years after implant, could not be independently confirmed through an evaluation of the provided cta imaging, as only one time-point of the abdomen was provided.However, it was observed that the proximal end of the device was 13.2 mm from the left renal artery, and the aortic neck diameter ranged from 27 mm to 30 mm (intended aortic diameter for the pxt231414 device ranges 19 mm to 21 mm) consistent with a potential migration.In addition, the reported type ia endoleak was confirmed as contrast was observed outside the implanted device and appeared to originate from the proximal end of the device.

• 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23289897
• Report Number: 2017233-2025-06695
• Device Sequence Number: 20201311
• Product Code: MIH
• UDI-Device Identifier: 00733132610143
• UDI-Public: (01)00733132610143(17)090331
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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
• Device Expiration Date: 03/31/2009
• Device Catalogue Number: PXT231414
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTHRITIS, CAD, CKD, DEPRESSION, DM, HTN, HLD, LAF
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White