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 Code	Material Invagination (1336)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, this patient underwent planned endovascular treatment of bi-lateral common iliac artery aneurysms and was implanted with gore® excluder® aaa endoprosthesis devices and gore® excluder® iliac branch endoprosthesis devices.Pre-procedure computed tomography angiography (cta) performed on (b)(6) 2025, determined the maximum diameter of the abdominal aorta measured 34mm with a maximum diameter proximal landing zone of 22mm, the maximum diameter of the left common iliac artery measured 29mm, the maximum diameter of the right common iliac artery measured 30mm.Successful access, delivery, and accurate deployment of the devices to their intended location, and retrieval of the delivery system and technical success were reported.There were no corrective procedure(s) or complications related to the device or procedure.The patient tolerated the procedure and was discharged to home (self-care) on (b)(6) 2025.On (b)(6) 2026, gore imaging sciences (gis) post review of follow-up imaging performed on (b)(6) 2025 reports an indeterminate endoleak with compression/infolding of the excluder conformable aaa endoprosthesis trunk-ipsilateral leg.Additionally, imaging determined the maximum diameter of the abdominal aorta measured 24mm and the maximum diameter of the left common iliac artery measured 29mm; the maximum diameter of the right common iliac artery measured 32mm.All devices are patent with no migration or device integrity issues.There has been no reintervention performed or scheduled to date.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25021981
• Report Number: 3007284313-2026-04745
• Device Sequence Number: 10261386
• Product Code: MIH
• UDI-Device Identifier: 00733132651030
• UDI-Public: (01)00733132651030(17)280627
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: 04/22/2026
• Initial Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 06/29/2025
• 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
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 160 KG