MAUDE Adverse Event Report: W. L. Gore & Associates, Inc. GORE® EXCLUDER® AAA Endoprosthesis; System, Endovascular Graft, Aortic Aneurysm Treatment

Catalog Number	PLC161200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic dissection (4870)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore on september 17, 2026 from the imedidata database: on (b)(6) 2026, a patient with abdominal aortic aneurysm (no iliac involvement) underwent primary procedure for endovascular treatment.One gore® excluder® conformable aaa endoprosthesis was implanted in infrarenal abdominal aorta, two gore® excluder® aaa endoprosthesis were implanted in the left and right common iliac artery respectively.On (b)(6) 2026, a subtle and non-flow limiting small dissection membrane in the right and left external iliac artery was reported.The dissection is uncomplicated and not adjacent to the stent grafts.This event is listed as related to treatment/procedure, ongoing, and not caused by a gore accessory, no treatment is required.On (b)(6) 2026, the patient was discharged from the hospital.
Additional Manufacturer Narrative
The patient referenced in this event file is enrolled in the (b)(4) together aortic registry and information regarding this event was gathered from the imedidata rave clinical study database (csd).D10: concomitant medical products: (relevant associated devices used with the device being reported on): gore® excluder® conformable aaa endoprosthesis, and another gore® excluder® aaa endoprosthesis.As part of our routine quality procedures, each batch of devices undergoes comprehensive quality control testing and inspections prior to release for distribution.Gore reviewed the manufacturing records associated with the reported lot number and verified that all release criteria had been met.Neither clinical images enabling direct assessment of product performance nor the product itself, which remains implanted, were available for evaluation.Based on the incident description and the subsequent investigation, the available information was insufficient to determine the cause of the reported event or establish a definitive root cause.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: dissection, perforation, or rupture of the aortic vessel and surrounding vasculature.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.

• 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 Silicon Valley B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; +1(928)526-3030
• MDR Report Key: 50929833
• Report Number: 3013164176-2026-03244
• Device Sequence Number: 16132953
• Product Code: MIH
• UDI-Device Identifier: 00733132618705
• UDI-Public: (01)00733132618705(17)290414
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P020004
• 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,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: PLC161200
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2026
• 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: See H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 147 LB