BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM HELIX DETACHABLE COIL

    MDR report key: 1023367 · Received April 2, 2008

    Report

    Report Number
    2029214-2008-00054
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 4, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS IMPLANTED IN THE PT.

    Description of Event or Problem · 1

    COILING TREATMENT OF AN ANEURYSM. IT WAS REPORTED THE COIL WAS PLACED INSIDE THE ANEURYSM AND A PORTION PROTRUDED INTO THE ARTERY. ATTEMPTS TO RE-POSITION THE COIL INTO THE ANEURYSM WERE NOT SUCCESSFUL. WHILE PERFORMING AN ANGIOGRAM, IT WAS REPORTED THAT THE COIL CAME OUT OF THE ANEURYSM AND MIGRATED TO THE MCA. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE COIL AND IT WAS LEFT IN THE MCA. AFTER THE PROCEDURE, THE PT AWOKE AND SHOWED SIGNS OF AN INFARCTION AND WAS UNABLE TO MOVE ONE SIDE OF THE BODY. ONE WEEK POST PROCEDURE, IT WAS REPORTED THE PT CONDITION HAS IMPROVED AND THE INFARCTION HAS LEFT NO DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM HELIX DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-6-HELIX 5038355

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability