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

Catalog Number	RLT311417
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2015, this patient underwent endovascular repair of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis featuring c3® deployment system.Pre-treatment cta showed that the maximum diameter of aortic aneurysm/lesion was 55.5mm.The follow up cta scans from (b)(6) 2019 to (b)(6) 2021 showed that the maximum diameter of aortic aneurysm/lesion increased in size from 53mm to 67mm.On (b)(6) 2022, the elective angiogram was performed and a type ii endoleak was determined.On (b)(6) 2022, the patient underwent the inferior mesenteric artery embolization procedure to treat an endoleak.According to the physician, the type ii endoleak caused the aneurysm enlargement.The leak was fixed.The patient is fine.Stable aneurysm diameter and undergoing continued surveillance.
Additional Manufacturer Narrative
H.6.Code c21: a review of the manufacturing records for the device is going to be conducted.Investigation is in process.The device remains implanted and is not available for analysis.Further information will be provided.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time 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.Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms and / or persistent 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18764541
• Report Number: 2017233-2024-04653
• Device Sequence Number: 4387811
• Product Code: MIH
• UDI-Device Identifier: 00733132619092
• UDI-Public: 00733132619092
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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: 01/31/2017
• Device Catalogue Number: RLT311417
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Race: White