BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 2924296 · Received January 22, 2013

    Report

    Report Number
    2029214-2013-00070
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    March 30, 2011
    Report Date
    January 8, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT. THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: 105-7100-080 / LOT: 8990684 / DOM: 07/21/2010 / EXP: 04/30/2013 (QTY 4). MODEL: 105-7100-080 / LOT: 9387299 / DOM: 12/13/2010 / EXP: 11/30/2013 (QTY 2). (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY. TREATMENT OF A 5.0CM ARTERIOVENOUS MALFORMATION (AVM) LOCATED IN THE DEEP PART OF THE LEFT CEREBELLUM, ELOQUENT AREA, HEMORRHAGIC REGION. THE PATIENT WAS FIRST TREATED WITH SEVEN ONYX 18 AND SIX ONYX 34 ON (B)(6) 2011. AS A RESULT, THE PATIENT DEVELOPED AN OLD CEREBRAL INFARCTION AND SUFFERED FROM ATAXIA OF THE LEFT ARM/LEG AND PARALYSIS. THE PHYSICIAN COMMENTED THAT THE SYMPTOMS WERE CAUSED BY FEEDER OCCLUSION. THE PATIENT HAD THROMBOPENIA THE NEXT DAY AND THE PHYSICIAN STATED THAT THIS WAS DUE TO THE USE OF HEPARIN. IT WAS REPORTED THAT THE THROMBOPENIA RESOLVED NATURALLY, BUT THE PATIENT STILL HAD THE OLD INFARCTION ON THE RIGHT CEREBELLUM, MILD CEREBELLAR ATAXIA, AND PARALYSIS ON HER 12 MONTH FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29193 ONYX LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 9394845

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability