BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM HELICAL DETACHABLE COIL

    MDR report key: 3161716 · Received June 11, 2013

    Report

    Report Number
    2029214-2013-00543
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 17, 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

    ONLY THE PUSHWIRE WAS RETURNED AND EVALUATION COULD NOT DETERMINED THE CAUSE OF THE EVENT.(B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ICA (INTERNAL CAROTID ARTERY) ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN HAD A DIFFICULT TIME INSERTING THE IMPLANT COIL INTO THE ANEURYSM; THEREFORE, HE TRIED TO PULL IT BACK INTO MICROCATHETER BUT IT WAS STUCK. UPON PULLING ON THE COIL WITH MORE FORCE, THE IMPLANT COIL DETACHED AND FELL OUT OF THE ANEURYSM. A STENT WAS DEPLOYED TO KEEP THE COIL IN PLACE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262533 AXIUM HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-1.5-2-HELIX 9641412

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S