BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3D DETACHABLE COIL

    MDR report key: 3070820 · Received April 22, 2013

    Report

    Report Number
    2029214-2013-00384
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 31, 2013
    Report Date
    March 31, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).

    Additional Manufacturer Narrative · 1

    THE DELIVERY PUSHER AND THE IMPLANT COIL WERE RETURNED FOR EVALUATION ALREADY DETACHED. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT.(B)(4).

    Description of Event or Problem · 1

    OFF-LABEL TREATMENT FOR INTESTINAL BLEEDING. DURING THE PROCEDURE, IT WAS REPORTED THAT TWO COILS BECAME STUCK AS THEY WERE INDIVIDUALLY ADVANCED THROUGH THE PROGREAT 25 CATHETER. UPON REMOVAL OF EACH COIL, THEY WERE FOUND DETACHED INSIDE THE INTRODUCER SHEATH.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.SAME EVENT AS MDR# 2029214-2013-00385.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171218 AXIUM 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-6-3D 9653548

    Patients

    Seq Age Sex Outcome Treatment
    1