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

Catalog Number	PLC181400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	05/02/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
H.6.Investigation findings code c20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation conclusions code d12: it should be noted that, per the gore® excluder® aaa endoprosthesis instructions for use, possible adverse events and complications associated with the use of the gore® excluder® aaa endoprosthesis that may occur include, but are not limited to: stroke.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 have not 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.
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, a patient was treated using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) system.A gore® excluder® aaa endoprosthesis contralateral leg was also used in the aorta.Proximal access was gained through a gore® dryseal flex introducer sheath in the right subclavian artery.The procedure was completed successfully.Early on (b)(6) 2025, within 24 hours of the initial procedure, the patient had some watershed infarcts.A ct of the chest showed nothing unusual.On (b)(6) 2025, the patient started having seizures and was intubated.According to the fsa, there was no notable thrombus.Post-operative images are not available.
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, a patient was treated using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) system.A gore® excluder® aaa endoprosthesis contralateral leg was also used in the aorta.Proximal access was gained through a gore® dryseal flex introducer sheath in the right subclavian artery.The procedure was completed successfully.Early on (b)(6) 2025, within 24 hours of the initial procedure, the patient had some watershed infarcts.A ct of the chest showed nothing unusual.On (b)(6) 2025, the patient started having seizures and was intubated.According to the fsa, there was no notable thrombus.On (b)(6) 2025, the physician reported that the patient had died, saying that the patient never recovered from the stroke.
Additional Manufacturer Narrative
B2.Outcomes updated to death.B4.Event description updated.G3/g4.Date manufacturer received by manufacturer is the date we learned of the death.H1.Type of reportable event updated to death.H.6.Health effect - impact code - added f02.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22132059
• Report Number: 3013164176-2025-02539
• Device Sequence Number: 20704675
• Product Code: MIH
• UDI-Device Identifier: 00733132618699
• UDI-Public: (01)00733132618699(17)270925
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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
• Device Catalogue Number: PLC181400
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 67 YR
• Patient Sex: Male