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

Catalog Number	PLA360400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	04/02/2024
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2015, this patient underwent treatment of abdominal aortic aneurysm rupture with gore® excluder® aaa endoprostheses (rlt351414/11417444).On an unknown date, a proximal type i endoleak was discovered.On (b)(6) 2017, the patient underwent a planned reintervention and two gore® excluder® aaa aortic extender components (pla360400/13671846, pla360400 / (b)(6) were implanted proximally to extend coverage.It is unknown if the endoleak was resolved.The patient tolerated the procedure and was discharged on (b)(6) 2017.On (b)(6) 2019, follow-up ultrasound determined the maximum diameter of the aneurysm measured 78.2mm.On (b)(6) 2024, follow-up computed tomography angiography (cta) reports a proximal type i endoleak not related to the device or procedure.The maximum diameter of the aneurysm measured 147.0mm, the patient was scheduled for a procedure at a future date however it was cancelled by the patient who expressed no additional procedures were wanted.On (b)(6) 2024, the patient presented to emergency room (er) with a ruptured aneurysm and the family opted for comfort care only.The patient expired in the er.
Additional Manufacturer Narrative
The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to endoleak.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
Additional devices implanted and/or related to this event: pla360400/(b)(6) udi (b)(4).
Additional Manufacturer Narrative
H1: corrected reportability determination.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21739696
• Report Number: 2953161-2025-01235
• Device Sequence Number: 21016385
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: (01)00733132618439(17)200109
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2025

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: 01/09/2020
• Device Catalogue Number: PLA360400
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/01/2025; 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White