BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 24767589 · Received April 2, 2026

    Report

    Report Number
    2017233-2026-07328
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 2, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132638529
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1, PATIENT IDENTIFIER (IN CONFIDENCE): CURRENTLY UNKNOWN. UNTIL FURTHER NOTICE, DATA PROVIDED IN THIS FIELD REFLECT GORE'S INTERNAL REFERENCE NUMBER FOR THIS CASE. ADDITIONAL PATIENT DATA HAVE BEEN REQUESTED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL THE PRE-RELEASE SPECIFICATIONS. A RELATIONSHIP BETWEEN THE DEATH OF THE PATIENT AND THE USE OF A GORE DEVICE CANNOT BE ESTABLISHED WITH THE CURRENTLY AVAILABLE AND HAS THEREFORE REQUESTED FURTHER DETAILS ON THIS MEDICAL DEVICE INCIDENT. 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

    IT WAS REPORTED TO GORE THAT ON (B)(6) 2026 THIS PATIENT UNDERWENT AN EMERGENT ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, THE PHYSICIAN SELECTED AN ANTEGRADE APPROACH AND INSERTED THE DEVICE INTO THE DESCENDING AORTA WITHOUT A GUIDEWIRE. WHEN ATTEMPTING TO RELEASE THE DEVICE, THE PHYSICIAN EXPERIENCED PROFOUND RESISTANCE WITHDRAWING THE SHEATH. REPORTEDLY, THE LEADING OLIVE BECAME ENTANGLED IN THE GRAFT, SEPARATED AND REMAINED IN THE PATIENT. IT WAS ALSO NOTED THAT SUBSEQUENTLY, THE GRAFT WAS NO LONGER POSITIONED AT IT¿S INTENDED LOCATION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A REINTERVENTION WAS PERFORMED AND THE PATIENT HAD EXPIRED THEREAFTER ON AN UNKNOWN DATE. IT IS CURRENTLY UNKNOWN IF THE PATIENT'S DEATH WAS LINKED TO A GORE DEVICE. FURTHER DETAILS HAVE THEREFORE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824134 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132638529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention