BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1132708 · Received August 22, 2008

    Report

    Report Number
    2953200-2008-00725
    Event Type
    Death
    Date Received
    August 22, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYS WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM 24 DAYS AGO. ANEURYSM MORPHOLOGY WAS NOT REPORTED AND THE ILIAC ARTERIES WERE NOT CALCIFIED OR TORTUOUS. THE LEFT ILIAC ARTERY WAS ANEURYSMAL. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT WAS IMPLANTED FIRST, FOLLOWED BY AN EXTENSION ILIAC LIMB WHICH WAS IMPLANTED TO ADDRESS A SMALL ANEURYSMAL ILIAC ARTERY ON THE LEFT SIDE. THE CONTRALATERAL LIMB STENT GRAFT WAS THEN IMPLANTED. ALL THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED. THERE WAS A SMALL AREA OF EXTRAVASATION IN THE ILIAC WHICH WAS BALLOONED WITH THE DELIVERY SYS BALLOON AND SUCCESSFULLY RESOLVED THE EXTRAVASATION. LATER THAT NIGHT, THE PT'S LEFT ILIAC ARTERY WAS FOUND TO HAVE RUPTURED AND THE PT EXPIRED. THE CAUSE OF THE LEFT ILIAC ARTERY RUPTURE IS UNK. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC VASCULAR NA V0010644

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death