BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 1023366 · Received April 2, 2008

    Report

    Report Number
    2029214-2008-00055
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED.

    Description of Event or Problem · 1

    EMBOLIZATION TREATMENT OF AN AVM WITH ONYX. DURING THE PROCEDURE, IT WAS REPORTED THE PHYSICIAN NOTICED THAT ONYX HAD UNINTENTIONALLY ENTERED THE RIGHT SIDE OF THE PT'S BRAIN. THE PROCEDURE (UNDER LOCAL ANESTHESIA) WAS STOPPED WHEN THE PT EXPERIENCED PAIN AND THE EMBOLIZATION APPEARED COMPLETE. IMMEDIATELY POST PROCEDURE, IT WAS REPORTED THE PT COULD NOT MAINTAIN ADEQUATE BLOOD PRESSURE AND INTRACRANIAL PERFUSION WAS DIMINISHED WHICH RESULTED IN LEFT SIDE HEMIPLEGIA. THE PHYSICIAN ADMINISTERED MEDICATIONS TO INCREASE BLOOD PRESSURE TO ADEQUATE LEVELS AND SYMPTOMS DISAPPEARED. THE PT COMPLETELY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 4622838 (3 EA)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention