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	TGMR404020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
On (b)(6) 2024, this patient underwent endovascular treatment of a zone 2 thoracic aortic aneurysm and was implanted with gore® tag® thoracic branch endoprosthesis (tbe: tac083415a/(b)(6), tsb081506a/(b)(6), and a gore® tag® conformable thoracic stent graft with active control system (ctag-ac: tgmr404020/(b)(6) as a distal extension coupled with a cook tapered graft 42mm x34mmx 165mm.The patient tolerated the procedure.On (b)(6) 2025, post computed tomgraph imaging determined a type iii endoleak reported to originate from between the cook tapered graft and the ctag-ac device.On (b)(6) 2025, the patient underwent reintervention the area of the leak was ballooned with gore® tri-lobe balloon catheter and successfully treated the type iii endoleak.It was determined that the type iii endoleak was at the base of the cook device and the end of the ctag-ac.It appeared to be caused by the cook graft not conforming in the bend proximally and leaking along side our ctag-ac device.Consequently, it was observed it was more of an issue with the cook device rather than the ctag-ac.The patient tolerated the procedure.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22118972
• Report Number: 2017233-2025-06255
• Device Sequence Number: 7157025
• Product Code: MIH
• UDI-Device Identifier: 00733132646852
• UDI-Public: (01)00733132646852(17)251010
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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: 10/10/2025
• Device Catalogue Number: TGMR404020
• 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: 05/15/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 82 KG