BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM 3D DETACHABLE COIL

    MDR report key: 3232800 · Received July 18, 2013

    Report

    Report Number
    2029214-2013-00620
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY PUSHER WAS RETURNED FOR EVALUATION AND THE EVENT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE IMPLANT COIL PREMATURELY DETACHED IN THE ANEURYSM AFTER THE PHYSICIAN REPOSITIONED IT MULTIPLE TIMES. THE DETACHED IMPLANT COIL WAS COMPLETELY INSIDE THE ANEURYSM; THEREFORE, NO ATTEMPT TO RETRIEVE IT WAS MADE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335051 AXIUM 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-10-30-3D 9389559

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability