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

Model Number RLT261414

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2020

Event Type  Injury  

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 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.

Manufacturer Narrative

Corrected data- g1: manufacturing site and address.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Type of Device: 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
• MDR Text Key: 227817660
• Report Number: 3007284313-2021-01231
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622450
• UDI-Public: 00733132622450
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2022
• Device Model Number: RLT261414
• Device Catalogue Number: RLT261414
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR