BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM 3D DETACHABLE COIL

    MDR report key: 2800516 · Received October 22, 2012

    Report

    Report Number
    2029214-2012-00564
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 PATIENT.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A RUPTURED INTERNAL CAROTID ANTERIOR COMMUNICATING ARTERY (ICA-A-COMM) ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO INSERT TWO IMPLANT COILS(SEQUENTIALLY) INTO THE RUPTURED ANEURYSM WITHOUT ANY PROBLEMS, BUT WAS NOT ABLE TO DETACH THE IMPLANT COILS WITH THE INSTANT DETACHER OR VIA THE MANUAL METHOD (WHICH IS AN ALTERNATIVE DETACHMENT METHOD STATED IN THE IFU). THE PHYSICIAN DECIDED TO RETRIEVE THE COILS AND THEY EACH DETACHED DURING RETRIEVAL. HE WAS ABLE TO USE THE DELIVERY PUSHERS TO INSERT THE COILS INTO PLACE ONE AFTER THE OTHER. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2012-00565

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-4-8-3D 9599723

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability