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

Catalog Number	CXA200005
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.H6: code d1102 - it should be noted that the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu) states: do not cover significant renal or mesenteric arteries with the endoprosthesis.Vessel occlusion may occur.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
On (b)(6) 2025, the patient underwent an endovascular procedure to treat a penetrating aortic ulcer (pau) utilizing a gore® excluder® conformable aaa endoprosthesis (cxa200005).Reportedly, the pau was 6 mm distal to the left renal artery and the device was intentionally placed about 2 mm into the left renal artery origin and deployed.A post-deployment aortogram showed the device was unintentionally covering most of the left renal artery, about 6-7 mm into the left renal artery origin.Reportedly, the physician attempted to pull the device down with a balloon and attempted to wire the left renal artery origin, however, all attempts were unsuccessful.The initial post-deployment photos showed blood flow into the left renal artery, but as the physician attempted to place a guidewire into the vessel, it occluded at some point which caused an impairment to blood flow.At this point, the physician elected to convert the procedure to an open repair and made a surgical bypass from the aorta to the left renal artery, re-establishing flow to the left renal artery.The cxa200005 remains implanted.The physician believes the cause of the event was starting the deployment of the cxa200005 too far proximal.Reportedly, the device deployed accurately, but the patient's breathing caused the aorta to significantly move up and down which then caused the reference marks on the screen for device deployment to be inaccurate.No clinical images are available.The patient tolerated the procedure.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6.Correction: removed d12 known inherent risk of device and d1102 unintended use error caused or contributed to event.Added d1103 cause traced to intentional off-label, unapproved, or contraindicated use.H6: code d1103 - it should be noted that the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu) states: the gore® excluder® conformable aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy.The aortic and iliac extender endoprosthesis as intended to be used after deployment of the gore® excluder® conformable aaa endoprosthesis.These extensions are intended to be used when additional length and/or sealing for aneurysmal exclusion is desired.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: brianna zipprich ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23750710
• Report Number: 3007284313-2025-04434
• Device Sequence Number: 9584031
• Product Code: MIH
• UDI-Device Identifier: 00733132650927
• UDI-Public: (01)00733132650927(17)270520
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CXA200005
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: APIXABAN, DEBROX, CHOLECALCIFEROL, VITAMIN D3; EPINEPHRINE, METFORMIN, PRILOSEC
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 69 KG