BEUDAMED
    FDA Adverse Event Summary report: N

    SOLITAIRE FR REVASCULARIZATION DEVICE 6MMX30MM

    MDR report key: 2961783 · Received February 7, 2013

    Report

    Report Number
    MW5028953
    Date Received
    February 7, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 7, 2013
    Manufacturer
    COVIDIEN
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH STROKE, RIGHT MIDDLE CEREBRAL ARTERY THROMBUS/OCCLUSION WAS FOUND. REVASCULARIZATION DEVICE WAS USED TO ATTEMPT TO REMOVE THE OCCLUSION. ON THE 2ND PASS, THE CAPTURE DEVICE (STENT) BECAME DETACHED FROM THE WIRE. ATTEMPTS TO RETRIEVE THE DEVICE WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51701 SOLITAIRE FR REVASCULARIZATION DEVICE 6MMX30MM NONE NRY COVIDIEN 959441

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other