BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1102016 · Received August 7, 2008

    Report

    Report Number
    2953200-2008-00651
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 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 AND CONCLUSIONS: (MODERATELY TORTUOUS). SECONDARY INTERVENTION. MEDTRONIC HAS RECEIVED THE STENT GRAFT DELIVERY SYSTEM AND THE ANALYSIS HAS BEEN COMPLETED. EVAL OF THE RETURNED DEVICE CONFIRMED THE KINK AT THE BALLOON AREA AS REPORTED IN THE COMPLAINT. THE CAUSE OF THE KINK IS MOST LIKELY DUE TO THE VESSEL ANATOMY. THERE WAS BLOOD VISIBLE ON THE DEVICE. THE STENT GRAFT WAS LOADED IN THE DELIVERY CATHETER. THERE WERE MULTIPLE KINKS ON THE SHEATH AT (MEASURED FROM THE END OF THE GRAFT COVER): 29 MM, 64 MM, 89 MM, 112 MM, 129 MM, 144 MM, 161 MM AND 185 MM.

    Description of Event or Problem · 1

    A TALENT BIFURCATED STENT GRAFT DELIVERY SYSTEMS WAS INSERTED INTO A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY IS UNKNOWN .VESSEL MORPHOLOGY WAS MODERATELY TORTUOUS. THE DEVICE WAS INSERTED INTO THE VESSEL HOWEVER WAS UNABLE TO BE ADVANCED TO THE INTENDED LANDING ZONE. DURING THE ADVANCEMENT THE DELIVERY CATHETER KINKED. THE DEVICE WAS REMOVED FROM THE PT WITHOUT ISSUE. THE PT WAS TREATED WITH ANOTHER DEVICE. THE STENT GRAFT DELIVERY SYSTEM WAS RECEIVED AND THE ANALYSIS IS PENDING. 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 V00100332

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK