BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM PRIME HELICAL DETACHABLE COIL

    MDR report key: 3231899 · Received December 6, 2012

    Report

    Report Number
    2029214-2012-00686
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TREATMENT OF A LARGE INFERIOR CAROTID ARTERY (ICA) ANEURYSM. DURING A BALLOON ASSISTED COILING TREATMENT, IT WAS REPORTED THAT THE LAST COIL (15TH COIL) WAS INTRODUCED INTO THE ANEURYSM AND HAD TO BE RE-POSITIONED DUE TO THE LARGE AMOUNT OF COILS ALREADY IN THERE AND WAS STRETCHED AND SEPARATED FROM THE PUSHER IN THE PROCESS. SUBSEQUENTLY, THE PHYSICIAN USED A SOLITAIRE STENT TO PIN THE SEPARATED END OF THE COIL AGAINST THE VESSEL WALL. NO 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 PRIME HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR APB-5-20HX-SS 9626639

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S