BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT CONVERTER

    MDR report key: 1715965 · Received June 9, 2010

    Report

    Report Number
    2953200-2010-01102
    Event Type
    Death
    Date Received
    June 9, 2010
    Date of Event
    May 12, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION RESULTS: DEATH, ARTERIAL TRAUMA/DISSECTION/PERFORATION; CHRONICALLY TOTALLY OCCLUDED LEFT ILLAC ARTERY, HISTORY OF SMOKING; CONVERTER USED AS THE MAIN DEVICE. CONCLUSIONS: CHRONICALLY TOTALLY OCCLUDED LEFT ILLAC ARTERY, HISTORY OF SMOKING; CONVERTER USED AS THE MAIN DEVICE.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS MILD TORTUOSITY AND SEVERE CALCIFICATION. THE PATIENT HAD A TOTALLY OCCLUDED LEFT ILLAC ARTERY. THE PATIENT HAS A HISTORY OF SMOKING AND ALCOHOL USE. THE RIGHT ILIAC ARTERY WAS DILATED WITH DILATORS DUE TO THE SEVERE CALCIFICATION. THE PHYSICIAN ELECTED TO PLACE A VIABAHN STENT FROM THE AORTIC BIFURCATION DOWN TO JUST PROXIMAL TO THE HYPOGASTRIC. THEN A SECOND VIABAHN WAS IMPLANTED BELOW THE HYPOGASTRIC ARTERY. THE PHYSICIAN HAD DIFFICULTIES ADVANCING THE TALENT CONVERTER TO THE INTENDED LANDING ZONE. THE DEVICE WAS WITHDRAWN AND THE VIABAHN STENTS WERE MODELED WITH AN 8X40 BALLOON AND A 10X40 BALLOON. THE CONVERTER DELIVERY SYSTEM WAS REINSERTED AND SUCCESSFULLY IMPLANTED AT THE INTENDED LANDING ZONE. IT WAS REPORTED THAT WHEN THE TALENT CONVERTER DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, THE PATIENT'S BLOOD PRESSURE DROPPED; HOWEVER, THERE WAS NO DIFFICULTY REMOVING IT. DURING THE MODELING AND STENT GRAFT IMPLANTING, THE PATIENT WAS STABLE WITH NO COMPLICATIONS. THE PHYSICIAN BELIEVES THAT THE HYPOGASTRIC ARTERY WAS TORN AND ELECTED TO PLACE A COVERED STENT BETWEEN THE VIABAHN STENTS BUT THE BLOOD PRESSURE WAS STILL LOW. THE PHYSICIAN FELT THAT THE COVERED STENT THAT WAS PLACED TO REPAIR THE HYPOGASTRIC ARTERY WAS PLACED TOO LOW; THEREFORE, ANOTHER COVERED STENT WAS IMPLANTED. THE ENTIRE ILIAC ARTERY WAS STENTED. THE PATIENT'S BLOOD PRESSURE WAS STILL UNSTABLE BUT IMPROVED SLIGHTLY; HOWEVER, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA. THE GROIN WAS PARTIALLY SURGICALLY OPENED, AND IT WAS NOTED THAT THE HYPOGASTRIC ARTERY WAS SEVERED FROM THE ILIAC ARTERY. THE PATIENT WAS OPENED FURTHER IN AN ATTEMPT TO CONTROL THE BLEEDING. THERE WAS RETROGRADE BLEEDING FROM THE LEFT TO THE RIGHT AND THE PHYSICIAN WAS UNABLE TO CONTROL THE BLEEDING. THE PATIENT EXPIRED DURING AN ATTEMPT TO REPAIR THE BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CONVERTER MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00389801

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death