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

Model Number	RMT281412
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use, potential adverse events that may occur and/or require intervention include but are not limited to, endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.It was reported that the patient had an extremely angulated proximal neck.On (b)(6) 2020, the patient presented with proximal type i endoleak due to the extremely angulated neck.Aneurysm enlargement was also present, although exact amount of enlargement was not provided.On the same day a reintervention was performed by implanting two gore® excluder® aaa endoprosthesis aortic extender components.The endoleak was resolved and the patient tolerated the procedure.
Additional Manufacturer Narrative
G1: manufacturing site name 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: 11108535
• Report Number: 3007284313-2021-01213
• Device Sequence Number: 14440747
• Product Code: MIH
• UDI-Device Identifier: 00733132610709
• UDI-Public: 00733132610709
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 06/30/2015
• Device Model Number: RMT281412
• Device Catalogue Number: RMT281412
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 07/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 89