BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM 3D AND HELIX DETACHABLE COIL

    MDR report key: 1026356 · Received April 8, 2008

    Report

    Report Number
    2029214-2008-00065
    Event Type
    Injury
    Date Received
    April 8, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 28, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. MODELS AND LOT NUMBERS OF OTHER AXIUM COILS: MODEL#: QC-25-50-3D; LOT#: 5315274; DATE MANUFACTURER: 03-2008; EXPIRATION DATE: 03-2009; MODEL#: QC-22-50-3D; LOT#: 5231904 (2 EA); DATE MANUFACTURER: 03-2008; EXPIRATION DATE: 03-2009; MODEL#: QC-20-40-HELIX; LOT#: 5261180 (3 EA); DATE MANUFACTURER: 03-2008; EXPIRATION DATE: 03-2009; MODEL#: QC-20-50-3D; LOT# 5283647 (2 EA); DATE MANUFACTURER: 03-2008; EXPIRATION DATE: 03-2009.

    Description of Event or Problem · 1

    COILING TREATMENT OF A CAROTID ANEURYSM. THE ANEURYSM WAS TREATED WITH NINE AXIUM COILS, FIVE NEXUS MORPHEUS (EV3) COILS, FIVE GDC (BSC) COILS AND ALL WENT WELL. TWO DAYS POST PROCEDURE, THE PATIENT EXPERIENCED HEADACHE WITH HIGH TEMPERATURE. THE PHYSICIAN NOTICED AN INFLAMMATION AND LATER, THE PATIENT WAS DIAGNOSED WITH MENINGITIS. IT WAS REPORTED THE PATIENT IS ON THE WAY TO RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM 3D AND HELIX DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-20-50-3D 5315274

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability