BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 10730518 · Received October 23, 2020

    Report

    Report Number
    2017233-2020-01378
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    September 28, 2020
    Report Date
    March 25, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646838
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    GR/G4; ADDED PMA/510K NUMBER P040043.

    Additional Manufacturer Narrative · 0

    THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS) DEVICE EVALUATION SHOWED THE FOLLOWING: - THE LOCKWIRE WAS SEPARATED FROM THE LOCKWIRE HANDLE, AND THE LOCKWIRE CONNECTOR WAS PLASTICALLY DEFORMED. GRAFT MATERIAL, ANGULATION FIBER PIECES, AND LOCKWIRE WERE IDENTIFIED AT THE DISTAL TRANSITION OF THE DEVICE. - THE CATHETER WAS CUT PROXIMAL TO THE DELIVERY HANDLE. - THE ANGULATION ASSEMBLY HANDLE WAS INCORRECTLY POSITIONED FACING THE FLUSHING PORT AND WAS UNABLE TO BE REMOVED FROM THE HANDLE ASSEMBLY. THE REPORTED EVENT DESCRIPTION DID NOT INCLUDE ANY OBSERVATIONS REGARDING THE ANGULATION ASSEMBLY HANDLE. THE FINDINGS OF THIS EVALUATION CONFIRMED THE LOCKWIRE WAS BROKEN FROM HANDLE. THERE WAS NO INDICATION OF ANY DAMAGE OR MANUFACTURING ANOMALY THAT COULD RELATE TO THE LOCKWIRE BREAKING FROM THE HANDLE CONNECTOR. THE REPORTED INABILITY TO REMOVE THE LOCKWIRE, REQUIRING IT TO BE CUT, COULD NOT BE CONFIRMED. BASED ON THE EVENT DESCRIPTION AND DEVICE EVALUATION, PER MD145952 REV.20, NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED FOR THE BROKEN LOCKWIRE AND NO CAPA REQUEST IS REQUIRED. H6: CODE 213 - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS

    Additional Manufacturer Narrative · 0

    H1/H2: THIS EVENT WAS ERRONEOUSLY REPORTED AS A REPORTABLE MALFUNCTION. THE EVENT IS A SERIOUS INJURY.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED EMERGENTLY FOR TREATMENT OF A THORACIC AORTIC ANEURYSM. THE PHYSICIAN CHOSE TO TREAT USING A FROZEN ELEPHANT TRUNK PROCEDURE, (OFF LABEL). THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED, BUT WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE, THE DEPLOYMENT WIRE BROKE. THE PHYSICIAN HAD TO CUT DOWN IN ORDER TO CUT, AND REMOVE THE WIRE. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE PHYSICIAN HAD NO OPINION REGARDING THE CAUSE OF THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190240 GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. TGMR404010 00733132646838

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention