BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1911764 · Received November 23, 2010

    Report

    Report Number
    2017233-2010-00519
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 4, 2008
    Report Date
    November 23, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED.

    Description of Event or Problem · 1

    AN ARTICLE WILL BE PUBLISHED ON PTS WHO UNDERWENT TREATMENT OF TRAUMATIC AORTIC TRANSECTIONS AND ACUTE TYPE B DISSECTIONS WITH THE GORE TAG THORACIC ENDOPROSTHESIS. POST-OPERATIVELY, THESE PTS PRESENTED WITH DEVICE COMPRESSION. THE PT CAPTURED IN THIS EVENT WAS TREATED FOR A TRAUMATIC AORTIC TRANSECTION WITH THREE GORE TAG THORACIC ENDOPROSTHESIS ON (B)(6), 2008. ON (B)(6), 2008, COMPRESSION ASSOCIATED WITH THE PROXIMALLY IMPLANTED GORE TAG THORACIC ENDOPROSTHESIS WAS IDENTIFIED. ON AN UNK DATE, THE PT UNDERWENT ENDOVASCULAR TREATMENT OF THE COLLAPSE. AN ADDITIONAL DEVICE WAS IMPLANTED, AND THE LEFT SUBCLAVIAN ARTERY WAS COVERED TO PROVIDE PROXIMAL EXTENSION. THE PT TOLERATED THE PROCEDURE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC WLG326 06337091

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R