BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1070059 · Received July 3, 2008

    Report

    Report Number
    2953200-2008-00505
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 13, 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
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: LACK OF INFO (DEVICE EVALUATION IS PENDING, FILM EVALUATION IS PENDING). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (MODERATE TORTUOUSITY OF THE ARTERIES).

    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 27 MONTHS AGO. ANEURYSM AND MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT DURING ANNUAL CT SCAN 20 MONTHS POST IMPLANT, THERE WAS INCREASE IN DIAMETER OF PROXIMAL AORTA FROM 28MM TO 32MM WITH CAUDAL MIGRATION APPROXIMATELY 40MM OF BIFURCATED STENT GRAFT AND PRESENCE OF A PROXIMAL TYPE 1 ENDOLEAK (SEE MFR # 2953200-2008-00504). THIS WAS SUCCESSFULLY REPAIRED ENDOVASCULARLY THREE WEEKS AGO WITH THREE TALENT AORTIC CUFFS AND THEY WERE DILATED WITH A RELIANT BALLOON. THE REPAIR WAS CHALLENGING DUE TO THE DEPLOYMENT LOCATION OF THE AORTIC EXTENSIONS BECAUSE OF THE DISEASE PROGRESSION PROXIMAL TO THE IMPLANTATION OF THE ORIGINAL BIFURCATED STENT GRAFT. THE AORTIC CUFFS WERE IMPLANTED IN OVERLAPPING FASHION. TRACKING OF THE DELIVERY SYSTEMS WAS DELICATE AND CHALLENGING BUT ADEQUATE FOR ALL THREE AORTIC EXTENSIONS. A SUPER STIFF GUIDEWIRE WAS USED. ANGULATION WAS MODERATE AT DEPLOYMENT OF ALL THREE AORTIC EXTENSIONS. AFTER DEPLOYMENT OF EACH AORTIC EXTENSION, DIFFICULTY WAS APPARENT AT THE REMOVAL OF THE DELIVERY SYSTEM. THE PHYSICIAN WAS UNABLE TO ESTABLISH A SMOOTH TRANSITION BETWEEN THE TAPERED TIP AND THE GRAFT COVER AFTER THE SECOND CUFF WAS IMPLANTED. IT APPEARED THAT THE SHEATH KINKED AT THE JUNCTION OF THE STENT STOP AND PREVENTED COMPLETE RETRACTION OF THE TAPERED TIP; HOWEVER, THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT FURTHER COMPLICATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE DELIVERY SYSTEM WAS RETURNED AND ITS EVALUATION IS PENDING. PLEASE NOTE THAT THIS MODEL NUMBER AXF3636W26AX IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00088595

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK