BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS

    MDR report key: 777756 · Received October 23, 2006

    Report

    Report Number
    777756
    Event Type
    Malfunction
    Date Received
    October 23, 2006
    Date of Event
    October 20, 2006
    Report Date
    October 23, 2006
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY OF ILIAC ARTERY, THE BALLOON MALFUNCTIONED AND THE STENT SHEARED OFF THE BALLOON. WHEN ATTEMPTING TO REMOVE THE STENT, STENT BROKE OFF IN VESSEL. PATIENT TAKEN TO OPERATING ROOM FOR REMOVAL OF STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMUS STENT, CARDIAC FGE EV3 INC. * 1539749

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR