BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM HELIX AND 3D DETACHABLE COIL

    MDR report key: 1417928 · Received July 21, 2009

    Report

    Report Number
    2029214-2009-00214
    Event Type
    Injury
    Date Received
    July 21, 2009
    Date of Event
    April 28, 2009
    Report Date
    July 1, 2009
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. MODELS AND LOT NUMBERS OF COILS INVOLVED: QC-3-4-3D; LOT# 6551129 - DOM - 9/4/2008 - EXP - 9/1/2011. QC-2-3-HELIX; LOT# 7021902 - DOM - 1/15/2009 - EXP - 1/1/2012. QC-1.5-2-HELIX; LOT# 7089021 - DOM - 2/6/2009 - EXP-2/1/2012. QC-1.5-2-HELIX; LOT# 7258125 - DOM - 3/17/2009 - EXP - 3/1/2012.

    Description of Event or Problem · 1

    FIVE AXIUM COILS WERE USED IN A TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT AFTER THE COILS WERE IMPLANTED, A LOOP OF A COIL WAS OBSERVED PROTRUDING INTO THE PARENT ARTERY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM HELIX AND 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-4-8-3D 7026367

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability