BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1070057 · Received July 3, 2008

    Report

    Report Number
    2953200-2008-00497
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION. EVALUATION RESULTS: SEVERE CALCIFICATION IN A FOCAL AREA. GRAFT COVER KINKED. DEVICE DISCARDED. CONCLUSION: SEVERE CALCIFICATION IN A FOCAL AREA.

    Description of Event or Problem · 1

    A TALENT BIFURCATED STENT GRAFT DELIVERY SYSTEMS WAS INSERTED INTO A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY IS UNKNOWN. VESSEL MORPHOLOGY WAS REPORTED AS SEVERE CALCIFICATION IN A FOCAL AREA. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT GRAFT DELIVERY SYSTEM, HOWEVER, DURING THE ADVANCEMENT, THE DELIVERY SYSTEM KINKED DUE TO THE SEVERE CALCIFICATION. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PHYSICIAN ELECTED TO PLACE ANOTHER DEVICE WHICH WAS SUCCESSFULLY DEPLOYED. THE KINKED DELIVERY SYSTEM WERE DISCARDED BY THE USER FACILITY. 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 CARDIOVASCULAR NA V00099020

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK