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

Model Number	RLT311417
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2014, the patient underwent endovascular procedure using gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.Pre-treatment computed tomography angiography (cta) showed that the maximum diameter of aortic aneurysm/lesion was 54mm.The patient tolerated the initial procedure.Reportedly, follow up scans from (b)(6) 2015 till (b)(6) 2020 determined that the aneurysm increased in size from 45mm to 71mm.Additionally, on (b)(6) 2020, a type ii endoleak was noted.On (b)(6) 2020, the patient underwent ir embolization procedure.No further adverse events have been reported.
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.This code is used to describe an endoleak.According to the gore® excluder® aaa endoprosthesis featuring c3® delivery system instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include but are not limited to: aneurysm enlargement and endoleak.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14553823
• Report Number: 3007284313-2022-01942
• Device Sequence Number: 17451058
• Product Code: MIH
• UDI-Device Identifier: 00733132619092
• UDI-Public: 00733132619092
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

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: 03/31/2017
• Device Model Number: RLT311417
• Device Catalogue Number: RLT311417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/31/2022
• Date Device Manufactured: 04/21/2014
• 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; Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White