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	08/13/2021
Type of Reportable Event	Serious Injury
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.Users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Specifically, the ifu warns that adverse events that may occur and / or require intervention include, but are not limited to endoleak.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2016, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.The aneurysm measured 61 mm.On (b)(6) 2021, a type ii endoleak was discovered and treated by means of explantation of the gore® excluder® aaa endoprosthesis with aorto-bi-iliac bypass.
Additional Manufacturer Narrative
H6: code 4755 (g07001) part/component/sub-assembly term not applicable.
Additional Manufacturer Narrative
H6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.
Additional Manufacturer Narrative
G1.Manufacturing site name and address: medical phoenix 2.32470 n north valley pkwy.Phoenix, az 85085.

• 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; 32470 n north valley pkwy; phoenix AZ 85085
• Manufacturer Contact: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12331952
• Report Number: 3007284313-2021-01549
• Device Sequence Number: 2826116
• Product Code: MIH
• UDI-Device Identifier: 00733132622467
• UDI-Public: 00733132622467
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/10/2021

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: 07/13/2018
• Device Model Number: RLT261416
• Device Catalogue Number: RLT261416
• 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: 08/16/2021
• Supplement Date Received by Manufacturer: 10/07/2021; 10/07/2021; 10/07/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 10/07/2021; 11/22/2021; 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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: A
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 82 KG