BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM DETACHABLE COIL

    MDR report key: 1702129 · Received May 26, 2010

    Report

    Report Number
    2029214-2010-00097
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    September 17, 2009
    Report Date
    April 26, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. MODEL # AND LOT# OF COILS USED: MODEL #: QC-2-4-HELIX, LOT #, 7675567, DOM: 8/4/2009, EXPIRATION: 8/1/2012. MODEL #: QC-2-4-HELIX, LOT#, 7464783, DOM: 5/19/2009, EXPIRATION: 5/1/2012. MODEL#: QC-2-4-HELIX, LOT#, 7298039, DOM: 3/28/2009, EXPIRATION: 3/1/2012. MODEL#: QC-1.5-2-HELIX, LOT#, 7126387 (QTY. 2), DOM: 2/19/2009, EXPIRATION: 2/1/2012. MODEL#: QC-2-2-HELIX, LOT#, 7668478, DOM: 7/29/2009, EXPIRATION: 7/1/2012. MODEL#: QC-2-1-HELIX, LOT#, 7142178, DOM: 2/17/2009, EXPIRATION: 2/1/2012.

    Description of Event or Problem · 1

    SEVERAL COILS WERE USED IN AN ANEURYSM COILING TREATMENT PROCEDURE. IT WAS REPORTED ONE OF THE IMPLANTED COILS PROTRUDED THROUGH THE ANEURYSM DOME RESULTING IN RE-BLEED. THE HEMORRHAGE WAS CONTROLLED AND THE PATIENT WAS REPORTED HAD SEVERE LEFT HEMIPARESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-8-3D 7657942

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability