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

Model Number	RLT351416
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
It was reported that the patient presented on (b)(6) 2015 with a thoracoabdominal aortic aneurysm (pre-implant ct diameter 87 mm) that was treated with the implantation of gore® excluder® aaa endoprosthesis in a chimney procedure.On (b)(6) 2020, a type ia and a type ii endoleak originating from a lumbar artery were identified that contribute to aneurysm growth (ct diameter 127 mm) were identified.On (b)(6) 2020, the endoleaks were treated with the implantation of a proximal aortic cuff and embolization of the lumbar artery and the aneurysm sac.The patient tolerated the procedure.
Additional Manufacturer Narrative
Updated d3 / added component code.
Additional Manufacturer Narrative
Updated g1.

• 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
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w kiltie ln; flagstaff AZ 86005
• Manufacturer Contact: joerg kersten ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11936936
• Report Number: 3007284313-2021-01447
• Device Sequence Number: 4226989
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2022

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: 08/31/2017
• Device Model Number: RLT351416
• Device Catalogue Number: RLT351416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 05/07/2021; 05/07/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 05/09/2022; 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White