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

Model Number	RLT351416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); No Code Available (3191)
Date of Event	06/16/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.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 and aneurysm enlargement.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.
Event or Problem Description
The following information was reported to gore through the global registry for endovascular aortic treatment (great 10-11): on (b)(6) 2014, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 49mm in diameter, and was implanted with gore® excluder® endoprostheses.The patient tolerated the procedure.On (b)(6) 2014, the maximum diameter of aortic aneurysm/lesion was 44mm.On (b)(6) 2015, the maximum diameter of aortic aneurysm/lesion was 46mm.From (b)(6) 2014 till (b)(6) 2018, the maximum diameter of aortic aneurysm/lesion increased in size from 36 to 48mm.It was reported that on (b)(6) 2018, a type ii endoleak was determined.Reportedly, the type ii endoleak supplied via branches of the right third lumbar artery and inferior mesenteric artery, and caused the aneurysm enlargement.On (b)(6) 2018, the patient underwent a mesenteric angiography and an embolization procedure.The patient tolerated the procedure.From (b)(6) 2018 till (b)(6) 2019, the maximum diameter of aortic aneurysm/lesion decreased in size from 47 to 37mm.On (b)(6) 2020, the maximum diameter of aortic aneurysm/lesion was 50mm.Reportedly, the cause of the aneurysm enlargement is a persistent type ii endoleak.No further adverse events have been reported.The physician is monitoring the patient.

• 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: 10623824
• Report Number: 2017233-2020-01328
• Device Sequence Number: 19471426
• Product Code: MIH
• UDI-Device Identifier: 00733132618484
• UDI-Public: 00733132618484
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2020

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: 07/31/2017
• Device Model Number: RLT351416
• Device Catalogue Number: RLT351416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 74