BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1202445 · Received October 8, 2008

    Report

    Report Number
    2953200-2008-00903
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: OTHER LACK OF INFO (UNK CAUSE OF DEPLOYMENT DIFFICULTY, DEVICE EVAL IS PENDING).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS TRACKED TO THE INTENDED LOCATION WITHOUT COMPLICATION; HOWEVER, WHEN THE HANDLE WAS ROTATED, THERE WAS NO STENT GRAFT DEPLOYMENT. THE DELIVERY SYSTEM WAS REMOVED FROM THE PT SINCE THE STENT GRAFT WAS STILL LOADED IN THE DELIVERY SYSTEM. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE DEVICE WAS RETURNED AND ITS EVAL IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00123842

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK