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

Model Number	RLT281414
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	02/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Concomitant medical products: gore® excluder® aaa endoprosthesis - stent graft contralateral leg - sn (b)(4).Gore® excluder® aaa endoprosthesis - stent graft iliac extender - sn (b)(4).Gore® excluder® aaa endoprosthesis - stent graft contralateral leg - sn (b)(4).Gore® excluder® aaa endoprosthesis - stent graft aortic extender - sn (b)(4).Device remains implanted in patient.The gore® excluder® aaa endoprosthesis instructions for use state: adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to aneurysm enlargement and endoleak.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.
Event or Problem Description
A patient presented with an abdominal aortic aneurysm on (b)(6) 2018, and was treated with a gore® excluder® aaa endoprosthesis.On (b)(6) 2018, a type ii endoleak was detected, no intervention was deemed necessary.On (b)(6) 2019, aneurysm sac growth was observed and was treated with embolization of one lumbar artery on (b)(6) 2019.After the embolization, ct scan indicated that there was no leak and an embolization of the second lumbar artery was not carried out.This event was reported previously with manufacturer¿s reference number (b)(4).Further growth of the aneurysm sac was observed on (b)(6) 2022.Embolization of the second lumbar artery was successfully carried out on (b)(6) 2022.
Additional Manufacturer Narrative
Corrected manufacturing site.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13862706
• Report Number: 3007284313-2022-01831
• Device Sequence Number: 20173051
• Product Code: MIH
• UDI-Device Identifier: 00733132622535
• UDI-Public: 00733132622535
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2022

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: 01/07/2021
• Device Model Number: RLT281414
• Device Catalogue Number: RLT281414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022; 08/18/2022; 09/30/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/21/2022; 08/19/2022; 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 88 KG