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	TGMR313110
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/09/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient underwent a frozen elephant trunk (fet) procedure on (b)(6) 2026, for treatment of a type a aortic dissection utilizing a gore® tag® conformable thoracic stent graft with active control system (ctag).On august 10, 2026, the field sales associate (fsa) was notified that the patient expired on (b)(6) 2026.Following the procedure, the physician reported concern that the device may have been implanted in the false lumen or, alternatively, may have migrated through a fenestration from the true lumen into the false lumen.The physician stated that the device appeared to be in the false lumen and that mesenteric malperfusion was present.An angiogram reportedly demonstrated no perfusion to the mesenteric vessels.The patient also experienced elevated potassium levels.The physician indicated that it was unclear whether the event represented initial device malposition or distal migration from the true lumen into the false lumen.Any migration distance was unknown.No deployment difficulties were reported.No completion angiogram was performed, and no imaging was available for review.The physician did not specifically attribute the patient's death to the ctag device.
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.

• 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 ; +1(928)526-3030
• MDR Report Key: 50621371
• Report Number: 2017233-2026-07995
• Device Sequence Number: 13440281
• Product Code: MIH
• UDI-Device Identifier: 00733132646777
• UDI-Public: (01)00733132646777(17)290425
• 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: 2026
• 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): 09/04/2026

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: TGMR313110
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2026
• 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: Other; Death
• Patient Sex: Unknown