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

Model Number	RLT351416
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2015, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.With an onset date of (b)(6) 2019, an expansion of the juxtarenal aneurysm neck was reported.On (b)(6) 2019, fixation of the stent graft was performed with 10 endoanchor¿ implants.
Additional Manufacturer Narrative
H6.Device code 1: corrected code.H6, code 22: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), complications associated with the use of the gore® excluder® aaa endoprosthesis may include but are not limited to: aneurysm enlargement, 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: 10204263
• Report Number: 2017233-2020-00457
• Device Sequence Number: 2613545
• Product Code: MIH
• UDI-Device Identifier: 00733132618484
• UDI-Public: 00733132618484
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 09/30/2017
• Device Model Number: RLT351416
• Device Catalogue Number: RLT351416
• Device Lot Number: 13180500
• 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: 06/27/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 66