BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM PRIME DETACHABLE COIL SYSTEM

    MDR report key: 2961787 · Received February 7, 2013

    Report

    Report Number
    MW5028958
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN EMERGENCY COILING PROCEDURE OF AN ANEURYSM, THE COIL BECAME DETACHED FROM THE GUIDE WIRE WHEN THE SURGEON ATTEMPTED TO PULL IT BACK FROM PARTIAL DEPLOYMENT IN THE ANEURYSM. THE COIL WAS DEFECTIVE AND IT WAS NOT THE INTENT OF THE SURGEON TO SEPARATE THE COIL FROM THE GUIDE WIRE WHEN IT SEPARATED. THIS RESULTED IN THE SURGEON HAVING TO GET THE INTERVENTIONAL RADIOLOGIST TO SNARE THE COIL WHICH REMAINED IN THE VESSEL. THE COIL WAS SNARED SUCCESSFULLY AND THE PT SUFFERED NO HARM AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51761 AXIUM PRIME DETACHABLE COIL SYSTEM 11.5 BARE PLATINUM SOFT HELIX EV3 AXIUM PRIME 6MM X 20CM KRA MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9626640

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention