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

Model Number	RLT281416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events with may occur and/or require intervention including, but not limited to, endoleak.
Event or Problem Description
On (b)(6) 2017, the patient was treated for an abdominal aortic aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system and a gore® excluder® aaa endoprosthesis.On (b)(6) 2020, during a follow up visit, imaging revealed a suspected type i endoleak, which caused the aneurysmal sac to enlarge by an unknown amount.The physician implanted a gore® excluder® aaa endoprosthesis and a gore® excluder® iliac branch endoprosthesis on each side to treat the endoleak.The patient tolerated the procedure.The physician had no opinion regarding the cause of the endoleak.
Additional Manufacturer Narrative
H10/11: additional excluder component plc141400 / 16275101 will be included in this report, as it is unknown which device may have been involved in the reported type i distal endoleak.

• 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: 10206511
• Report Number: 3007284313-2020-00162
• Device Sequence Number: 3271205
• Product Code: MIH
• UDI-Device Identifier: 00733132622542
• UDI-Public: 00733132622542
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 08/28/2020

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: 06/11/2020
• Device Model Number: RLT281416
• Device Catalogue Number: RLT281416
• Device Lot Number: 16393582
• 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: 06/29/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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: Required Intervention
• Patient Age: 85 YR