BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2265002 · Received September 21, 2011

    Report

    Report Number
    2017233-2011-00481
    Event Type
    Injury
    Date Received
    September 21, 2011
    Date of Event
    August 5, 2011
    Report Date
    September 20, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MFG RECORDS FOR THE DEVICE IS BEING CONDUCTED. PLEASE NOTE THE MEDWATCH ASSOCIATED WITH THE AAA DEVICE IS BEING REPORTED UNDER MFR REPORT # 2953161-2011-00202.

    Description of Event or Problem · 1

    ON (B)(6) 2009 THE PT WAS TREATED FOR A DISSECTION THAT EXTENDED FROM THE THORACIC AORTA DOWN TO THE ABDOMINAL AORTA. A GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED TO COVER THE PROXIMAL ENTRY TEAR AND A GORE EXCLUDER AAA ENDOPROSTHESIS ILIAC EXTENDER COMPONENT WAS IMPLANTED TO COVER THE DISTAL TEAR. ON (B)(6) 2011 ANOTHER TEAR IN THE DISSECTION OCCURRED IN THE PT'S ABDOMINAL AORTA AND COVERED WITH THE GORE EXCLUDER AAA ENDOPROSTHESIS. THE PT TOLERATED THE PROCEDURE.

    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 WLG426 06394677

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R