BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM-HYDRO

    MDR report key: 1715968 · Received June 9, 2010

    Report

    Report Number
    2953200-2010-01103
    Event Type
    Death
    Date Received
    June 9, 2010
    Date of Event
    April 14, 2010
    Report Date
    May 12, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION RESULTS: DEATH, ARTERIAL TRAUMA/DISSECTION/PERFORATION; SEVERELY CALCIFIED ARTERIES; STENT GRAFT IMPLANTED IN SEVERELY CALCIFIED ARTERIES.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT'S ILIAC ARTERIES WERE SEVERELY CALCIFIED. A CONDUIT WAS REQUIRED TO BE PLACED ON ONE SIDE WHICH WAS THE RIGHT SIDE BECAUSE IT WAS SEVERELY CALCIFIED. IT WAS REPORTED THAT THERE WAS DIFFICULTY ADVANCING THE MAIN DEVICE UP ON THE RIGHT BUT IT WAS FINALLY ABLE TO ADVANCE AND DEPLOY (SEE MFR # 2953200-2010-01103). THREE ADDITIONAL STENT GRAFTS WERE IMPLANTED INCLUDING A 14X24 TALENT LIMB WHICH NEEDED TO BE EXTENDED WITH AN ANEURX CUFF FOR EXTRA LENGTH. THE PHYSICIAN NOTED THAT HE FELT A JOLT AS HE WAS REMOVING THE DELIVERY SYSTEM OF THE LAST DEVICE WHICH WAS THE ANEURX CUFF THAT WAS USED AS A FLARE; HOWEVER, THIS WAS NOT NOTED AT THE TIME OF IMPLANT (SEE MFR # 2953200-2010-01104). APPARENTLY THE LEFT ILIAC WAS TORN 1.5 CM DISTAL TO THE HYPOGASTRIC ARTERY, BUT BECAUSE THE PATIENT WAS TALL, THE SCOPE OF VISION DID NOT SHOW THIS SECTION AND THE VITAL SIGNS WERE FINE. THE PATIENT WAS CLOSED AND 2 HOURS POST IMPLANT THE PATIENT STARTED TO CRASH. THE PATIENT WAS SENT BACK TO THE OPERATING ROOM AND ACCESS WAS GAINED. THE ILIAC ARTERY WAS FOUND TO HAVE TORN. ATTEMPTS WERE MADE TO SURGICALLY REPAIR THE ARTERY; HOWEVER, THE PATIENT HAD LOST A LOT OF BLOOD AND HAD MULTI ORGAN FAILURE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM-HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00414650

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death