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

Catalog Number	CXA280005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: imaging evaluation: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿ 3 radiographic jpeg images provided for evaluation.¿ no name, date, or demographics on the images.¿ cannot manipulate the images in any way.(window leveling, rotating, etc.) ¿ cannot provide diameter or length measurements with jpeg images.¿ pseudoaneurysm can be seen at the distal anastomosis of the right common iliac artery, confirming statement above.¿ cannot confirm presence of type iii endoleak.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 information was reported to gore: on (b)(6) 2023, this patient underwent an endovascular treatment for anastomotic pseudoaneurysm of the previously implanted graft using gore® excluder® aaa endoprosthesis (aortic extender alone).Two aortic extenders were implanted.On (b)(6) 2026, a new pseudoaneurysm developed at the distal anastomosis of the right common iliac artery and it was ruptured, resulting in an emergency procedure request.Upon evaluation, another pseudoaneurysm was also identified at the distal endo of the previously implanted aortic extender, with enlargement of the aneurysm.Two stent grafts were implanted in the right iliac artery to cover the ruptured aneurysm and an additional aortic extender of gore® excluder® conformable aaa endoprosthesis was implanted distal to the previous devices.The final angiography showed a type iii endoleak on the aortic extenders, but no further treatment was given.It was left for monitoring.The patient tolerated the procedure.The reporting physician commented as follows: the pseudoaneurysm might have been caused by contact between the edge of the distal end of the aortic extender and the vascular graft.On (b)(6) 2026, another reintervention was performed for the remaining type iiia endoleak.Additional stent grafts were implanted to reline the aortic extenders.The final angiography confirmed that the endoleak disappeared.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24467895
• Report Number: 3013164176-2026-02920
• Device Sequence Number: 9506611
• Product Code: MIH
• UDI-Device Identifier: 00733132650958
• UDI-Public: (01)00733132650958(17)280624
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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 Catalogue Number: CXA280005
• 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: 02/05/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female