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

Model Number	RLT261414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, this patient underwent endovascular treatment for an abdominal aortic aneurysm with a maximum diameter of 68 mm, and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2016, follow-up computed tomography angiography (cta) determined the maximum diameter of the aneurysm to be 74mm.On (b)(6) 2016, follow-up cta determined the maximum diameter of the aneurysm to be 75mm.On (b)(6) 2016, the patient required in-patient hospitalization for a type ii endoleak and enlargement of the abdominal aortic aneurysm.On (b)(6) 2017, the patient underwent catheterization of the aorta, the right internal iliac artery and superior mesenteric artery with arteriogram.The patient tolerated the procedure.
Additional Manufacturer Narrative
The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur include, but are not limited to include: endoleak, aneurysm enlargement patient medical history includes but is not limited to: hypercholesterolemia, hypertension, tobacco use, thromboembolic event, diabetes mellitus no medications for the patient were known.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12780976
• Report Number: 3007284313-2021-01650
• Device Sequence Number: 20339825
• Product Code: MIH
• UDI-Device Identifier: 00733132622450
• UDI-Public: 00733132622450
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 03/18/2018
• Device Model Number: RLT261414
• Device Catalogue Number: RLT261414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 157 KG
• Patient Race: White