BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 2360324 · Received December 6, 2011

    Report

    Report Number
    2029214-2011-00392
    Event Type
    Injury
    Date Received
    December 6, 2011
    Date of Event
    August 15, 2011
    Report Date
    November 7, 2011
    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 DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT. MODEL# OF OTHER ONYX INVOLVED:105-7100-080.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. IT WAS REPORTED THAT THE CATHETER LEAKED DURING ONYX INJECTION. CONSEQUENTLY, ONYX WAS OBSERVED IN THE BASILAR ARTERY. NO COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT.SAME EVENT AS MDR# 2029214-2011-00391.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Disability