MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RLT311415
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2017 the patient underwent endovascular reintervention of an existing non-gore stent graft using a gore® excluder® aaa endoprosthesis and a conformable gore® tag® thoracic endoprosthesis.On (b)(6) 2020 the patient underwent an additional reintervention to treat a proximal type i endoleak identified on the gore® excluder® aaa endoprosthesis.It was reported that aneurysm growth was also identified.The suspected cause of the type i endoleak was a lack of apposition of the gore® excluder® aaa endoprosthesis on the previously implanted non-gore device.The reintervention was an open surgery to treat and bypass the endoleak by sewing in an additional graft.The reintervention successfully treated the type i endoleak, and no further issues were reported.
Additional Manufacturer Narrative
D1: corrected brand name.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10030901
• Report Number: 3007284313-2020-00125
• Device Sequence Number: 14396790
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2020

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: 06/22/2020
• Device Model Number: RLT311415
• Device Catalogue Number: RLT311415
• Device Lot Number: 16436851
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR