BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAGORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1609353 · Received February 12, 2010

    Report

    Report Number
    2017233-2010-00049
    Event Type
    Death
    Date Received
    February 12, 2010
    Date of Event
    April 27, 2008
    Report Date
    February 11, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2008, THE PT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND A RUPTURED ULCERATION OF THE THORACIC AORTA. HE WAS HYPERTENSIVE WITH A BLOOD PRESSURE OF 250/110. THERE WAS NO ACTIVE EXTRAVASATION OF CONTRAST ON CT, ALTHOUGH HE HAD A LEFT HEMOTHORAX. HE WAS STABILIZED WITH NO DROP IN HEMOGLOBIN. ON (B) (6) 2008, THE PT WAS TREATED WITH A GORE TAG THORACIC ENDOPROSTHESIS FOR A PSEUDOANEURYSM IN THE DESCENDING THORACIC AORTA. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE, BUT SHORTLY AFTER RETURNING TO THE INTENSIVE CARE UNIT, THE PT HAD A SUDDEN DROP IN BLOOD PRESSURE AND WENT INTO CARDIAC ARREST. ATTEMPTS AT RESUSCITATION WERE UNSUCCESSFUL, AND HE EXPIRED. ACCORDING TO A NURSE IN THE PHYSICIAN'S OFFICE, THE CAUSE OF DEATH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAGORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG326 05746313

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death LABETALOL| DIOVAN| OXYCONTIN| INSULIN| CLONIDINE| NEPHROCAPS| PERCOCET| CALCIUM