BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR

    MDR report key: 2192466 · Received July 6, 2011

    Report

    Report Number
    2192466
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    March 31, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO PLACE A 4TH STENT, THE STENT CAME OFF THE BALLOON AND HAD TO BE SNARED THROUGH A 6 FRENCH SHEATH ADVANCED PARALLEL TO THE 7 FRENCH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC VASCULAR * 0005077524

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR CARDIAC DRUGS