BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3173659 · Received June 17, 2013

    Report

    Report Number
    2029214-2013-00560
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ADDITIONAL INFORMATION STATING THAT THE PROCEDURE WAS TO TREAT AN ICA (INTERNAL CAROTID ARTERY) MEASURING 1.2CM IN SIZE.(B)(4).

    Additional Manufacturer Narrative · 1

    THE PIPELINE, PUSHWIRE, AND MARKSMAN CATHETER WERE RETURNED FOR EVALUATION AND THE PIPELINE WAS FOUND FULLY OPEN; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT TWO PIPELINES TWISTED UPON DELIVERY. THE PIPELINES WERE CORKED AND REMOVED FROM THE PATIENT. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR # 2029214-2013-00559.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274438 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-20 9668336

    Patients

    Seq Age Sex Outcome Treatment
    1