BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR

    MDR report key: 3033833 · Received April 3, 2013

    Report

    Report Number
    2029214-2013-00332
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 5, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND ONE OF THE TEARDROP STRUTS WAS FOUND TO BE BROKEN. CROSS-SECTIONAL ANALYSIS OF THE BREAK POINTS INDICATED THAT THE FAILURE MODE WAS DUE TO DUCTILE OVERLOAD. PUSHWIRE SEPARATION. (B)(4).

    Description of Event or Problem · 1

    DURING INSERTION OF THE SOLITAIRE STENT INTO THE REBAR 27 CATHETER, IT WAS REPORTED THAT THE PUSHWIRE BROKE. NO INJURY WAS REPORTED WITH THE PATIENT AS THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136033 SOLITAIRE FR FLOW RESTORATION NRY EV3 NEUROVASCULAR SRD-6-30 9675159

    Patients

    Seq Age Sex Outcome Treatment
    1