BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX AVM

    MDR report key: 1976857 · Received February 2, 2011

    Report

    Report Number
    2029214-2011-00025
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VIAL OF ONYX WAS RETURNED FOR EVALUATION, BUT DID NOT CONTAIN ENOUGH OF THE EMBOLIC SOLUTION TO PERFORM TESTING. TESTING FOR RADIO-OPACITY WAS PERFORMED ON THE RETAINED SAMPLE FROM THE SAME LOT AND WAS FOUND TO BE WITHIN SPECIFICATION. (B)(4)

    Description of Event or Problem · 1

    EMBOLIZATION TREATMENT OF AN AVM WITH ONYX. DURING PROCEDURE, IT WAS REPORTED THAT ONYX COULD NOT BE VISUALIZED UNDER THE FLUOROSCOPY. NO PATIENT INJURY REPORTED.SAME EVENT AS MDR# 2029214-2011-00026

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 8805910

    Patients

    Seq Age Sex Outcome Treatment
    1