BEUDAMED
    FDA Recall Terminated

    GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.

    Recall: Z-0048-2018 · Initiated September 25, 2017

    Recall

    Recall Number
    Z-0048-2018
    Event Number
    78132
    Firm
    W L Gore & Associates, Inc.
    FEI Number
    2017233
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    September 25, 2017
    Posted
    October 25, 2017
    Terminated
    August 27, 2019
    Address
    1500 N Fourth St., Flagstaff, AZ, 86003-2400

    Description

    GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.

    Reason

    Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.

    Action

    The firm contact their consignee with a safety notice by letter on 09/25/2017. Gore is updating its Instructions for Use (IFU) to include the following new warnings and precautions: " If abnormal or inconsistent deployment line resistance is felt during deployment initiation, STOP deployment action immediately. If device remains constrained, remove device through the introducer sheath. If resistance is felt during removal through the sheath, stop and withdraw device and introducer sheath together. " If the device is in a partially deployed state and remains attached to the catheter, physicians should strongly consider conversion to immediate open surgical repair to avoid additional procedure time and potential harm from additional endovascular maneuvers.

    Distribution

    Worldwide.

    Quantity

    12,197units