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

Model Number	RLT261416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis featuring c3 deployment system 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) 2014 this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis featuring c3 deployment system.Between follow up dates on (b)(6) 2021 and (b)(6) 2021, the aneurysm has expanded from 5.5 cm to 7.1 cm with an undetermined source of endoleak.On (b)(6) 2021, a reintervention occurred to treat the unidentified endoleak.The trunk-ipsilateral leg endoprosthesis was extended proximally with an aortic extender endoprosthesis to the left renal artery, and distal extension was achieved into the right common iliac with a contralateral leg endoprosthesis to rule out what was perceived as possible type i proximal and type i distal endoleaks.The procedure concluded successfully, and the patient will be followed up later to see if the endoleak was resolved.
Additional Manufacturer Narrative
G1.Manufacturing site name and address updated from "medical phoenix 2 b/p" to "woody mountain.".

• 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: 11855901
• Report Number: 3007284313-2021-01437
• Device Sequence Number: 4662354
• Product Code: MIH
• UDI-Device Identifier: 00733132622467
• UDI-Public: 00733132622467
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 07/31/2017
• Device Model Number: RLT261416
• Device Catalogue Number: RLT261416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 88