BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 2861005 · Received December 6, 2012

    Report

    Report Number
    2029214-2012-00693
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND EVALUATION SHOWED THAT THE IMPLANT COIL WAS DAMAGED AND STUCK INSIDE THE INTRODUCER SHEATH. IT WAS ALSO FOUND TO BE ATTACHED TO THE DELIVERY PUSHER.(B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED AS IT WAS IMPLANTED IN THE PATIENT.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN WAS NOT ABLE TO DETACH A COIL AFTER IT WAS INSERTED. THE PHYSICIAN TRIED TO RETRACT THE COIL AND CATHETER TO INSERT THEM AGAIN, BUT THE COIL WAS RELEASED WITH ABOUT TWO-THIRDS OF IT STILL IN THE BLOOD VESSEL. SUBSEQUENTLY, THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR A CRANIOTOMY. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-4-3D 9559912

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S