BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 21481234 · Received February 27, 2025

    Report

    Report Number
    2017233-2025-05869
    Event Type
    Death
    Date Received
    February 27, 2025
    Date of Event
    February 4, 2025
    Report Date
    February 27, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS IT IS UNKNOWN WHICH DEVICE(S) IS DIRECTLY IMPLICATED IN THIS DEATH EVENT, THE FOLLOWING DEVICE(S) WILL ALSO BE INCLUDED IN THIS REPORT: CATALOG #TAC083415A/ SERIAL # (B)(6)/ UDI # (B)(4). H6: CODE A26- USED TO CAPTURE INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE IF GORE DEVICE CONTRIBUTED TO DEATH. H6: CODE E2401- USED TO CAPTURE INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE IF ANY HEALTH EFFECT APPEARS TO HAVE OCCURRED. C1. CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. IT SHOULD BE NOTED THAT, PER THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO DEATH. 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

    ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES IN ZONE 3. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. THE COMPLETION ANGIOGRAM SHOWED A SUCCESSFUL CASE WITH SUCCESSFUL TREATMENT OF DISEASED AREA. THE ANEURYSM WAS SEALED. SOMETIME AFTER THE PROCEDURE, AFTER REPRESENTATIVES HAD LEFT THE HOSPITAL, THE PATIENT BECAME UNSTABLE AND ALL LIFESAVING EFFORTS WERE UNSUCCESSFUL. THE PATIENT EXPIRED THAT SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608839 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Death| R