BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1063029 · Received June 19, 2008

    Report

    Report Number
    2953200-2008-00448
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS, CONCLUSIONS: (MODERATELY TORTUOUS VESSELS WITH SOME PLAQUE). EVAL SUMMARY: THERE WAS EXTREME ACCORDION DEFORMATION ON THE SHEATH AT 35MM FROM THE EDGE OF THE GRAFT COVER, WHICH MAY HAVE RESULTED FROM THE USER PULLING TOO HARD TO RE-SHEATH NOSE CONE. THE DISTAL END OF THE GRAFT COVER APPEARED CURVED IN, POSSIBLY RESULTED FROM THE NOSE CONE BEEN RETRACTED AT AN ANGLE. THE DEVICE WAS FLUSHED WITH WATER AND EXTRAVASATION OF BLOOD/WATER WAS OBSERVED COMING AT A POINT DISTAL TO THE STENT STOP. A 4MM LONGITUDINAL CRACK IN THE SHEATH WAS MEASURED AT 175MM FROM THE DISTAL END OF THE GRAFT COVER. CAUSE OF CRACK COULD NOT BE DETERMINED BUT VESSEL TORTUOSITY AND PLAQUE COULD BE A FACTOR.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED AND THE ARTERIES WAS LARGE, WITH MODERATE TORTUOSITY AND SOME PLAQUE. IT WAS REPORTED THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED. THE NOSE CONE WAS RETRACTED INTO THE GRAFT COVER; HOWEVER, IT COULD NOT BE FULLY SEATED WITHIN THE GRAFT COVER. THE REMOVAL OF THE DELIVERY SYSTEM WAS CONTINUED AND WHEN 10 CM OF ITS LENGTH REMAINED IN THE PT THERE WAS BLOOD COMING OUT THROUGH THE CATHETER. THE NURSE PRESENT AT THE PROCEDURE BLOCKED THE LEAKING WITH HER FINGER AND THE REMAINDER OF THE DELIVERY SYSTEM WAS REMOVED FROM THE PT UNEVENTFULLY. IT IS UNK WHAT THE DELIVERY SYSTEM ENCOUNTERED DURING THE PROCEDURE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00088657

    Patients

    Seq Age Sex Outcome Treatment
    1