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	TGM454510
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	09/01/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
H6: code a26- used to capture insufficient information available to determine if gore device contributed to stroke.As it is unknown which device is directly implicated in this stroke event, the following devices (same device family) will also be included in this report: catalog #tgm454510/ serial #unk/ udi # unk 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
The field sales associate (fsa) reported the following to gore: on (b)(6) 2025, the patient underwent an endovascular procedure to treat an aortic dissection utilizing the gore® tag® conformable thoracic stent graft with active control system (ctag).It was reported during the procedure; the physician informed the fsa that a ctag device from consignment had been implanted.Subsequently, they requested an additional ctag device.As the fsa was en route to another case, he delivered the requested device and departed.They physician later informed the fsa that the patient tolerated the procedure.On (b)(6) 2025, the fsa was informed that the patient had experienced a major stroke.Following the decision to withdraw care, the patient passed away on either (b)(6) 2025.Additional details indicated that the patient had a significant amount of thrombus in the carotid artery, which was suspected to have broken off, causing the stroke.The exact location within the carotid artery where the thrombus originated is unknown.The physician does not believe the event was device-related.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23074151
• Report Number: 2017233-2025-06616
• Device Sequence Number: 11923689
• Product Code: MIH
• UDI-Device Identifier: 00733132646982
• UDI-Public: (01)00733132646982(17)261128
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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 Catalogue Number: TGM454510
• 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: 09/03/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Sex: Female