BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13481161 · Received February 8, 2022

    Report

    Report Number
    2017233-2022-02725
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Date of Event
    January 23, 2022
    Report Date
    March 15, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646777
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS) DEVICE EVALUATION SHOWED THE FOLLOWING: IT APPEARS THAT THE FULL LENGTH OF THE SECONDARY DEPLOYMENT (SDL) WAS RETURNED AND THERE IS NO INDICATION OF THE SDL BREAKING DURING DEPLOYMENT. THE LOCKWIRE WAS SEPARATED FROM THE LOCKWIRE HANDLE AND RETURNED IN TWO PIECES. THE RETURNED LOCKWIRE WAS PROPERLY ROUTED THROUGH THE CATHETER. THE ANGULATION FIBER HANDLE WAS RETURNED WITHOUT THE ANGULATION FIBERS OR CONNECTOR. DURING TESTING FOR DESIGN VERIFICATION, PROCESS QUALIFICATION, AND ONGOING QUALITY CONTROL TESTING, DEVICES ARE TESTED IN ANATOMICAL MODELS REPRESENTATIVE OF CMDS INDICATED USE. BASED ON THE LOCKWIRE BEING SEPARATED FROM THE LOCKWIRE HANDLE, THIS SUGGESTS THAT THERE WAS LIKELY DIFFICULTY WHEN INITIALLY REMOVING THE LOCKWIRE. THERE IS POTENTIAL THAT OFF-LABEL USE IN AN ANTEGRADE HYBRID FASHION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE EVENT DESCRIPTION AND DEVICE EVALUATION, NO MANUFACTURING DEFICIENCIES COULD BE CONFIRMED SO NO CAPA REQUEST IS REQUIRED. EVENTS WILL CONTINUE TO BE MONITORED BY GORE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THIS PATIENT UNDERWENT TREATMENT FOR A TYPE A DISSECTION AND HEMIARCH USING A FROZEN ELEPHANT TRUNK PROCEDURE AND A GORE® TAG®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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776433 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. TGMR313110 00733132646777

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female