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

Catalog Number	PLC181400
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

• 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: 50929830
• Report Number: 3013164176-2026-03243
• Device Sequence Number: 13445555
• Product Code: MIH
• UDI-Device Identifier: 00733132618699
• UDI-Public: (01)00733132618699(17)290228
• 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: PLC181400
• 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: 03/02/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 147 LB