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

Catalog Number	PXT261414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2010, the patient underwent an endovascular procedure to treat an abdominal aortic aneurysm (aaa) utilizing three gore® excluder® aaa endoprosthesis (trunk ipsilateral leg and two contralateral legs).On (b)(6) 2024, reportedly, patient was lost to follow ups.There is substantial aneurysmal growth (size unknown) over the last 14 years, physician stated no allegation against devices but the growth is due to disease progression and physician decided to do an elective reintervention procedure.The patient underwent reintervention procedure to treat aneurysmal growth utilizing a gore® excluder® iliac branch endoprosthesis (iliac branch component) and gore® excluder® conformable aaa endoprosthesis (aortic extender conformable).Physician extended proximally from the trunk ipsilateral leg with the aortic extender conformable and the iliac branch component was put in the right common iliac artery then bridged with distal extension on the left.It is unknown which contralateral leg was on the left side from the initial procedure.On (b)(6) 2024, patient was discharged and is doing well.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to aneurysm enlargement and reoperation.Since it is unknown which device is directly implicated in this complaint, (b)(4) / udi-di (b)(4) , udi-di (b)(4) will be included on this report.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.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.

• 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 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19495673
• Report Number: 3007284313-2024-03299
• Device Sequence Number: 8545882
• Product Code: MIH
• UDI-Device Identifier: 00733132610228
• UDI-Public: 00733132610228
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2024

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: 03/31/2013
• Device Catalogue Number: PXT261414
• 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: 05/14/2024
• Initial Report FDA Received Date: 06/09/2024
• Date Device Manufactured: 04/26/2010
• 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: Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Male