BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1790295 · Received August 6, 2010

    Report

    Report Number
    2953200-2010-01513
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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

    (B)(4). EVAL, RESULTS: SEVERELY TORTUOUS AND CALCIFIED VESSELS. EVAL, CONCLUSION: SEVERELY TORTUOUS AND CALCIFIED VESSELS.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS INSERTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE ILIAC ARTERIES WERE SEVERELY TORTUOUS CALCIFIED. IT WAS REPORTED THAT THE DEVICE WOULD NOT ADVANCE AND KINKED. IT WAS REMOVED FROM THE PT. THE VESSELS WERE BALLOONED AND DILATED WITH DILATORS AND ANOTHER TALENT DEVICE, WHICH WAS ABLE TO BE INSERTED AND DEPLOYED SUCCESSFULLY. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00461841

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK