MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGM343410
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient underwent an endovascular procedure to treat a thoracic saccular aortic aneurysm using a gore® tag® conformable thoracic stent graft with active control device.The patient tolerated the procedure and discharged home on (b)(6) 2025.On (b)(6) 2025, the pre- treatment imaging showed that the maximum diameter of the aorta was 34.6mm.On (b)(6) 2025, a site follow up cta showed that the maximum diameter of the treated thoracic aorta was 51mm.No endoleak was noticed.On (b)(6) 2025, a gore core lab follow up imaging noticed an indeterminate endoleak.The gore imaging commented there was an appearance of an endoleak approximately mid treated lesion.Unable to determine source.When was looking back at pre-procedure there appears to be about 9mm of seal zone between the distal lsa and the proximal aspect of the lesion.The event is ongoing.No treatment was done to fix an endoleak.The physician is monitoring the patient.According to the physicians, the graft is well seated with no evidence of endoleak.
Additional Manufacturer Narrative
C21: a review of the manufacturing records for the device is going to be conducted.The investigation is in process.The device remains implanted and is not available for analysis.Code f28 was used to cover the indeterminate endoleak.The cause of endoleak is unknown.The physician is monitoring the patient.According to the physicians, the graft is well seated with no evidence of endoleak, however, a gore core lab follow up imaging noticed an indeterminate 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
A review of manufacturing records of the device indicated the lot met pre-release specifications.The device remains implanted and is not available for analysis.Code f28 was used to cover the indeterminate endoleak.The cause of endoleak is unknown.The physician is monitoring the patient.According to the physicians, the graft is well seated with no evidence of endoleak, however, a gore core lab follow up imaging noticed an indeterminate endoleak.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• 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 SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24264387
• Report Number: 2017233-2026-07113
• Device Sequence Number: 9948114
• Product Code: MIH
• UDI-Device Identifier: 00733132646951
• UDI-Public: (01)00733132646951(17)270110
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• 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,Followup
• Report Date (Section B): 02/12/2026

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 Catalogue Number: TGM343410
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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; Other
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic