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

Model Number	RMT231214
Medical Device Problem Codes	Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the following patient populations: pseudoaneurysms resulting from previous graft placement.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2013 a patient was undergoing treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.On (b)(6) 2018 the patient reportedly had a right groin pseudoaneurysm with infected ptfe grafts.On (b)(6) 2018 the patient underwent external iliac to mid ptfe graft bypass; triple ligation of femoral vessels and closure of the pseudoaneurysm.Reported separately see psts event# (b)(4) medwatch#3007284313-2019-00095 on january 21, 2020 another pseudoaneurysm was reported, occurring in the right groin treatment zone.This was treated by means of a gore® viabahn® endoprosthesis 8mm x 100mm.The patient tolerated the procedure.
Additional Manufacturer Narrative
D.11.A second device was added to the investigation and this device also met all pre-release specifications.Pxc121000 sn# (b)(6) udi: (b)(4).Device code updated.

• 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: 10631563
• Report Number: 3007284313-2020-01095
• Device Sequence Number: 2605053
• Product Code: MIH
• UDI-Device Identifier: 00733132610518
• UDI-Public: 00733132610518
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: RMT231214
• Device Catalogue Number: RMT231214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H.10./11.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 68 YR
• Patient Weight: 86