BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM HELIX DETACHABLE COIL

    MDR report key: 1143670 · Received August 29, 2008

    Report

    Report Number
    2029214-2008-00153
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 8, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION SHOWED THE COIL COULD NOT BE DETACHED BECAUSE THE RELEASE WIRE WAS FOUND JAMMED IN THE PUSHER AND COULD NOT BE PULLED.

    Description of Event or Problem · 1

    COILING TREATMENT OF AN A-COM ANEURYSM. IT WAS REPORTED AFTER PLACEMENT OF THE COIL (QC3-6-3D), THE COIL FAILED TO DETACH AND WAS WITHDRAWN. AN ANGIOGRAM WAS PERFORMED AND SHOWED AN ANEURYSM INTACT WITH PARTIAL THROMBUS. SINCE THE CATHETER WAS IN GOOD POSITION, ANOTHER COIL (QC-3-6-HELIX) WAS THEN USED. DUE TO THE PRESENCE OF THROMBUS IN THE ANEURYSM SAC, THE COIL LOOPS WERE PROLAPSING INTO THE PARENT ARTERY AND NOT FORMING IN THE ANEURYSM SAC. THE COIL WAS THEN WITHDRAWN AND THE PROCEDURE ENDED. POST PROCEDURE, THE PATIENT WAS REPORTED TO HAVE A MYOCARDIAL INFARCT AND THEREFORE COULD NOT BE TAKEN UP FOR THE SECOND PROCEDURE. ON FOLLOW-UP, IT WAS REPORTED THE PATIENT STILL IN HOSPITALIZED DUE TO A STROKE AND MYOCARDIAL INFARCT. SAME EVENT AS MDR# 2020914-2008-00154.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM HELIX DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-6-3D 5853299

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization