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

Catalog Number	RLT261412
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	09/22/2026
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 Phoenix 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; +1(928)526-3030
• MDR Report Key: 50918116
• Report Number: 3007284313-2026-05111
• Device Sequence Number: 17642033
• Product Code: MIH
• UDI-Device Identifier: 00733132622443
• UDI-Public: (01)00733132622443(17)250319
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 03/19/2025
• Device Catalogue Number: RLT261412
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2022
• 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; Other; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 192 LB