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

Catalog Number	PLC141000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore from the imedidata study database: on (b)(6) 2025, a patient was treated in an aorto-uni-iliac (aui) procedure for a degenerative juxtarenal aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) system, including two gore® excluder® aaa endoprosthesis contralateral leg devices.After the patient was closed, but before the patient extubated, the patient lost neuro-monitoring signals due to spinal cord ischemia.The patient was converted to open repair to perform an emergent femoral-femoral bypass to reperfuse the spinal cord via the right internal iliac.Following the fem-fem bypass, neuromonitoring signals were regained.Reportedly, the right common iliac artery was chronically occluded prior to the procedure.According to the physician, the spinal cord ischemia was presumably due to aortic coverage.Note that although an aui was being performed, the physician was not intending to perform a fem-fem bypass until after the spinal cord ischemia occurred.
Additional Manufacturer Narrative
The patient referenced in this event file is enrolled in the aaa 24-01 clinical study and information was obtained from the imedidata clinical database.Additional gore® tag® device captured on this report: sn: (b)(6), udi: (b)(4), catalog: plc231000.H.6.Type of investigation code b20: 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.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.

• 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: 23454997
• Report Number: 3013164176-2025-02734
• Device Sequence Number: 8057223
• Product Code: MIH
• UDI-Device Identifier: 00733132618637
• UDI-Public: (01)00733132618637(17)280716
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

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: PLC141000
• 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: 10/07/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2025
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White