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

Model Number	RLT261414
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis featuring c3 deployment system instructions for use, 20mm of healthy proximal aortic seal zone is required for implant of the trunk-ipsilateral leg component.
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment of an endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis featuring c3 deployment system.The aortic seal zone was only 15mm and did not meet the inclusion criteria of the instructions for use.Therefore, the physician attempted to secure the trunk-ipsilateral leg component to the proximal aortic seal zone with staples.On (b)(6) 2020, the patient presented with the trunk-ipsilateral leg component that had migrated out of proximal aortic neck.The staples that were used in the original procedure did not hold.No aneurysm enlargement has been noted.
Additional Manufacturer Narrative
Corrected data- g1: manufacturing site and address.

• 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
• MDR Report Key: 11203175
• Report Number: 3007284313-2021-01231
• Device Sequence Number: 2231364
• Product Code: MIH
• UDI-Device Identifier: 00733132622450
• UDI-Public: 00733132622450
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 07/20/2022
• Device Model Number: RLT261414
• Device Catalogue Number: RLT261414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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: Other
• Patient Age: 74 YR