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

Catalog Number	CXT261412
Medical Device Problem Codes	Migration (4003); Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	12/11/2025
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 b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.Imaging summary evaluation: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿one time point available for evaluation: post-implantation cta dated (b)(6) 2025.¿the length from the left renal artery (lra) to the circumferential proximal device appears to be ~6.5mm, by centerline.¿the maximum abdominal aortic aneurysm (aaa) diameter appears to be 66.9mm x 73.7mm.¿there appears to be contrast in a set of lumbar arteries communicating with contrast pooling in the posterior aneurysmal sac on the delayed contrast axial image series.¿pooling contrast in the aaa is not identified on the arterial contrast image set.¿increased visible pooling contrast on a delayed contrast image set is indicative of a type ii endoleak.¿with available images there appears to be confirmation of a type ii endoleak involving a set of lumbar arteries.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
The following was reported to gore: on (b)(6) 2021, the patient underwent an endovascular procedure to treat an abdominal aortic aneurysm (aaa) utilizing a gore® excluder® conformable aaa endoprosthesis (trunk-ipsilateral conformable), and two gore® excluder® aaa endoprosthesis (contralateral legs).A recent cta (date unknown) demonstrated aneurysm sac growth from 54mm on (b)(6) 2024, to 65mm on (b)(6) 2025.The source of the endoleak was unclear, and an angiogram was recommended.On (b)(6) 2025, an angiogram revealed a type 1a endoleak with approximately 6mm of proximal migration of the trunk-ipsilateral conformable.A gore® excluder® conformable aaa endoprosthesis (aortic extender conformable) was deployed to extend the proximal seal to the renal arteries, successfully resolving the endoleak.The patient tolerated the procedure well, and no complications were reported.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23990981
• Report Number: 3007284313-2026-04506
• Device Sequence Number: 10523197
• Product Code: MIH
• UDI-Device Identifier: 00733132651030
• UDI-Public: (01)00733132651030(17)230629
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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 Expiration Date: 06/29/2023
• Device Catalogue Number: CXT261412
• 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: 12/11/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 79 KG