BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

    MDR report key: 1905728 · Received November 18, 2010

    Report

    Report Number
    2953200-2010-02275
    Event Type
    Death
    Date Received
    November 18, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL: RESULTS: (DEATH, ARTERIAL TRAUMA/DISSECTION/PERFORATION), (TORTUOUS, CALCIFIED, AND BRITTLE VESSEL).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN 8 CM ABDOMINAL AORTIC ANEURYSM. THE COMMON ILIAC ARTERIES WERE TORTUOUS, CALCIFIED, AND BRITTLE. THE LEFT COMMON ILIAC ARTERY HAD AN ACUTE TURN, BUT THE PHYSICIAN ATTEMPTED TO STRAIGHTEN THE VESSEL WITH A GUIDE WIRE. THE 11 FR SHEATHS WERE INSERTED ON EACH SIDE. WHEN THE SHEATH ON THE RIGHT SIDE WAS REMOVED, THE PT'S BLOOD PRESSURE WENT DOWN FROM 100 TO 0. THE SHEATH WAS RE-INSERTED AND THEN A RELIANT BALLOON WAS INSERTED IN THE RCIA AND WHEN THE BALLOON WAS INFLATED, THE BLOOD PRESSURE WENT UP. A RETROGRADE ANGIOGRAM WAS PERFORMED ON THE RIGHT SIDE AND IDENTIFIED A TEAR ON THE RCIA AT WHERE THE TIP OF THE SHEATH WAS. ANOTHER MFR' STENT WAS PUT IN TO COVER THE TEAR. THE BALLOON WAS LEFT INFLATED, BUT WHEN THE BALLOON PRESSURE WAS LET DOWN, THE PRESSURE STARTED TO DROP. THE PT WAS STABILIZED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICE FROM THE LEFT SIDE AND WHEN THE SHEATH WAS REMOVED, THE SAME THING HAPPENED, SO THE SHEATH WAS PUT BACK IN AND ANOTHER MFR'S STENT WAS PLACED. ANOTHER RELIANT WAS INFLATED ON THE LEFT SIDE. THE PT WENT INTO SHOCK, THEREFORE, THE ANESTHESIOLOGIST PERFORMED CPR. THE PT'S BLOOD PRESSURE WENT UP TO THE 80S WHICH WAS THE PT'S BASELINE. THEN THE SHEATH AND RELIANT BALLOON WERE REMOVED FROM THE RIGHT SIDE, AND THE PRESSURE WENT DOWN THE 30S. THE PHYSICIAN PROMPTLY INSERTED THE STENT GRAFT DELIVERY DEVICE, BUT COULD NOT ADVANCE IT PAST THE MID PORTION OF THE AORTA. THE PHYSICIAN BELIEVES THAT THE PT¿S VESSELS SPASMED. THE PT WENT INTO SHOCK AND EXPIRED. THE PHYSICIAN BELIEVES THAT THE PT'S ARTERIES WERE TOO BRITTLE AND HEART WAS NOT STRONG ENOUGH AND COULD NOT HANDLE THE SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00512219

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death