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

Model Number	RMT231414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The following was reported by the gore field sales agent (fsa): on (b)(6) 2012, the patient presented with an aneurysm and had an evar repair using two gore® excluder® aaa endoprostheses.The surgery was reportedly a success and the patient tolerated the procedure.On an unknown date in 2021 the patient had a ct scan and an indeterminate endoleak was found and the patient was scheduled for a re-intervention.On (b)(6) 2021, the patient had a re-intervention where it was reportedly found that the patient had a type ii endoleak.Three additional excluder devices were implanted (2 aortic extenders and a contra leg).It was also reportedly found that the hypogastric artery was feeding the aneurysm sac, so the physician made the decision to coil the artery.The patient reportedly tolerated the surgery.The physician stated the endoleak was most likely due to the patients age and lifestyle.
Additional Manufacturer Narrative
The causes and effects of type ii endoleaks, are well documented.When a type ii endoleak is present, the seal around the graft attachment zones causes a pressure drop within the sac which, in turn, causes the retrograde flow of blood from small branch vessels back into the aneurysm sac.Historical endovascular data has demonstrated this event is not specific to individual endovascular device design.Rather, such data has demonstrated this phenomenon is likely the result of the anatomy in which the endovascular procedure is being performed and the principles of operation of endovascular stent grafts.This includes the size and number of branch vessels originating from the excluded aneurysm sac, and the amount of collateral vessels capable of supplying blood to them.The clinical implication of type ii endoleaks can be the prevention of sac thrombosis, continued aneurysm sac expansion, possible aneurysm rupture, and death.Type ii endoleaks are reported in 10¿25% of abdominal endograft cases and in 1¿20% of thoracic endograft cases.They may be diagnosed at the time of graft implantation, at the first follow-up imaging study, or in a delayed fashion months or years after the evar/tevar procedure.These leaks have also been noted to spontaneously resolve and, at times, reappear on subsequent studies.
Additional Manufacturer Narrative
Added e1: us zip code.Added g3/g4, h1/h2 and h6.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to endoleak.

• 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: sara collum ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12845154
• Report Number: 3007284313-2021-01667
• Device Sequence Number: 4080910
• Product Code: MIH
• UDI-Device Identifier: 00733132610556
• UDI-Public: 00733132610556
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2022

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: 08/31/2014
• Device Model Number: RMT231414
• Device Catalogue Number: RMT231414
• 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: 10/27/2021
• Supplement Date Received by Manufacturer: 12/10/2021; 02/16/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/06/2022; 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2011
• 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; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 106 KG