BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 23074151 · Received September 17, 2025

    Report

    Report Number
    2017233-2025-06616
    Event Type
    Death
    Date Received
    September 17, 2025
    Date of Event
    September 1, 2025
    Report Date
    September 17, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646982
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636401 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132646982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| D