BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERED STENT ICAST

    MDR report key: 4479394 · Received January 28, 2015

    Report

    Report Number
    MW5040548
    Event Type
    Malfunction
    Date Received
    January 28, 2015
    Date of Event
    January 26, 2015
    Report Date
    January 28, 2015
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    NIV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE FIRST ICAST MD ATTEMPTED TO IMPLANT MALFUNCTIONED. THIS IS THE SECOND ONE OPENED. IT ALSO MALFUNCTIONED. THIS IS THE SECOND ONE OPENED. IT ALSO MALFUNCTIONED BUT MD WAS ABLE TO "SHIMMY" THE STENT BACK ON THE BALLOON AND IMPLANTED IN PT'S LET RENAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63302 COVERED STENT ICAST COVERED STENT ICAST NIV ATRIUM MEDICAL CORP 218655131

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR