BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 3231898 · Received December 6, 2012

    Report

    Report Number
    2029214-2012-00682
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 7, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION WITHOUT THE IMPLANT COIL. THE CAUSE FOR THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS ALL PARTS OF THE PUSHER WERE WITHIN SPECIFICATIONS AND ABSENT OF THE IMPLANT COIL. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE BOSTON EXCEL 14 CATHETER INSIDE THE COOK 6FR SHUTTLE AND ARRIVED AT THE SAC OF THE ANEURYSM WITH SOME FRICTION. THE PHYSICIAN BEGINS TO INSERT THE AXIUM IMPLANT COIL INTO THE ANEURYSM, BUT THE IMPLANT COIL PREMATURELY DETACHES SO HE PUSHED THE IMPLANT COIL INTO THE ANEURYSM AND CONCLUDED THE PROCEDURE. NO PT INJURY WAS REPORTED WITH THE PT 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 9352103

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability