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

Model Number	PLA260300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/05/2017
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.The device remains implanted and is not available for analysis.This code is used to describe an endoleak.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.Please note that the date of event will be used as (b)(6) 2017 - the date when the aneurysm increased in size.
Event or Problem Description
On (b)(6) 2016, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 86mm in diameter and was implanted with gore® excluder® aaa endoprostheses.Also, the aortic branch vessel procedure was done, and the right internal iliac artery was embolized.Reportedly, the amplatzer plug placed within the right internal iliac artery.The patient is enrolled in the grt 10-11 study.The patient tolerated the initial procedure.The follow-up on (b)(6) 2016, showed that the maximum diameter of the aortic aneurysm/lesion was 82mm.The follow-up on (b)(6) 2016, showed that the maximum diameter of the aortic aneurysm/lesion was 65.7mm.Reportedly, from june 5, 2017 to january 17, 2020, the maximum diameter of the aortic aneurysm/lesion increased in size from 70mm to 97mm.It was reported that on (b)(6) 2020, a type ii endoleak was determined.Reportedly, the ct did not identify a specific endoleak, however, concerns arose regarding lumbar arteries extending back towards the sac that could be contributing.On (b)(6) 2020, the angiogram was performed and the presence of the lumbar artery extending back towards the aortic sac was identified.The same day, on (b)(6) 2020, the patient underwent the coil embolization procedure of the left lumbar artery.Reportedly, using a microcatheter and angled guidewire, the branch arising off the internal iliac contributions to lumbar arteries was cannulated.Three branches were selected to be cannulated and each was embolized with coils.Final imaging showed the filling of internal iliac artery but no further contribution or filling through the lumbar arteries back towards the aortic sac.The procedure was completed successfully.No type i or type iii endoleaks were identified.The patient tolerated the procedure.It was reported that the follow-up on (b)(6) 2020, showed that the maximum diameter of the aortic aneurysm/lesion was 99mm.Also, a possible ongoing type ii endoleak was suspected.It was reported that the imaging was reviewed with a physician and he did not believe the need for reintervention.The physician decided to monitor the patient.The follow-up on (b)(6) 2020, showed that the maximum diameter of the aortic aneurysm/lesion was 99mm.No further adverse events have been reported.Reportedly, the aneurysm size did not change from the follow-up on (b)(6) 2020.The patient is doing well, and the next appointment was scheduled for (b)(6) 2021.

• Brand Name: GORE EXCLUDERAAA 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: 11455159
• Report Number: 2953161-2021-01052
• Device Sequence Number: 11542648
• Product Code: MIH
• UDI-Device Identifier: 00733132618774
• UDI-Public: 00733132618774
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: 05/31/2018
• Device Model Number: PLA260300
• Device Catalogue Number: PLA260300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/10/2021
• 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: 78
• Patient Weight: 81