BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3182100 · Received June 21, 2013

    Report

    Report Number
    2029214-2013-00568
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 2, 2013
    Report Date
    June 2, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE, PUSHWIRE, AND MARKSMAN CATHETER WERE RETURNED FOR EVALUATION WITH THE PIPELINE RELEASED FROM THE CAPTURE COIL; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT OPHTHALMIC ICA (INTERNAL CAROTID ARTERY) SACCULAR ANEURYSM MEASURING 7MM IN SIZE. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PIPELINE COULD NOT BE RELEASED FROM THE CAPTURE COIL DESPITE ROTATION OF THE PUSHWIRE; THEREFORE, IT WAS REMOVED FROM THE PATIENT. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283502 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77450-20 9722735

    Patients

    Seq Age Sex Outcome Treatment
    1