BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 9706918 · Received February 13, 2020

    Report

    Report Number
    2029214-2020-00142
    Event Type
    Injury
    Date Received
    February 13, 2020
    Date of Event
    February 13, 2020
    Report Date
    February 13, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    UDI-DI
    00836462005044
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS AND THE EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. NO CORRECTIVE ACTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT RESISTANCE WAS FELT WHEN THE MARATHON CATHETER WAS ATTEMPTED TO BE RETRIEVED. THE MARATHON CATHETER EVENTUALLY BROKE AT THE DISTAL SECTION, AS IT WAS STUCK IN THE ONYX. THE CATHETER DISTAL SECTION WAS LEFT IN THE SUPERIOR CEREBELLAR ARTERY (SCA). THE PATIENT DID NOT HAVE NEUROLOGICAL DETERIORATION POST THE INTERVENTION. EMBOLIZE THE SCA WITH ONYX18 (ABOUT 10 MINUTES) AND THE MARATHON WAS PULLED TO RETRIEVE. THE INTERMEDIATE CATHETER FUBUKI 4.2 WAS RAISED AND SUPPORT WAS PROVIDED, BUT IT WAS UNABLE TO RETRIEVE IT. THE DEVICE WAS BROKEN DURING PULLING. THE INJECTION WAS INTERRUPTED FOR BASIC 30 SECONDS UNIT. MAX120 SECONDS. THERE WAS A BACKFLOW THAT WAS ABOUT 1CM. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE ARTERIOVENOUS MALFORMATION (AVM) WAS IN THE SUPERIOR CEREBELLAR ARTERY (SCA). THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168905 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7100-060 A907932 00836462005044

    Patients

    Seq Age Sex Outcome Treatment
    1 Other