BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3232593 · Received July 18, 2013

    Report

    Report Number
    2029214-2013-00631
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSHWIRE WAS RETURNED FOR EVALUATION AND IT WAS FOUND BROKEN INTO TWO SEGMENTS. CROSS-SECTIONAL ANALYSIS OF THE FRACTURE SURFACES INDICATED THAT THE PUSHWIRE FAILED DUE TO TORSIONAL OVERLOAD.(B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT THE CAPTURE COIL SEPARATED FROM THE PUSHWIRE AFTER THE PIPELINE WAS DEPLOYED AND THE BROKEN SEGMENT WAS REMOVED WITH A SOLITAIRE STENT.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334383 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71450-35 9495990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S