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

Model Number	RLT351418
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/03/2019
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
On (b)(6) 2015, this patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis featuring c3® deployment system.On (b)(6) 2019, a type ii endoleak was identified.On the same day, the endoleak was treated with embolization with onyx coils.The patient referenced in this event file is enrolled in a post-market prospective observational cohort registry designed to obtain data on device performance and clinical outcomes of patients treated with gore endovascular aortic products through the global registry for endovascular aortic treatment (great).Medidata rave® is the clinical study database (csd), capturing the data through the grt 10-11 module.The above information was obtained from the csd.

• 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: 10860843
• Report Number: 3007284313-2020-01157
• Device Sequence Number: 16781390
• Product Code: MIH
• UDI-Device Identifier: 00733132618491
• UDI-Public: 00733132618491
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

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: 09/30/2017
• Device Model Number: RLT351418
• Device Catalogue Number: RLT351418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 85