BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR

    MDR report key: 2972497 · Received February 21, 2013

    Report

    Report Number
    2029214-2013-00140
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND THE STENT WAS FOUND DETACHED.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A STROKE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SOLITAIRE DETACHED IN THE CLOT ON THE SECOND PASS. BLOOD FLOW TO THE MCA (MIDDLE CEREBRAL ARTERY) WAS RESTORED.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76406 SOLITAIRE FR FLOW RESTORATION NRY EV3 NEUROVASCULAR SFR-4-20 9621572

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability