BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1133164 · Received August 22, 2008

    Report

    Report Number
    2953200-2008-00723
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    MEDTRONIC CARDIO VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: MODERATE CALCIFICATION AND SEVERE TORTUOSITY. GRAFT COVER KINKED. OTHER, DEVICE DISCARDED. CONCLUSION: MODERATE CALCIFICATION AND SEVERE TORTUOSITY.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY IS UNKNOWN. VESSEL MORPHOLOGY WAS MODERATE CALCIFICATION AND SEVERE TORTUOSITY. IT WAS REPORTED THAT THE STENT GRAFT WAS UNABLE TO BE ADVANCED TO THE INTENDED LANDING ZONE AND KINKED DUE TO THE SEVERE TORTUOSITY. THE STENT GRAFT DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH AN ANEURX STENT GRAFT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIO VASCULAR NA V00132528

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR