BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 4105877 · Received September 11, 2014

    Report

    Report Number
    2029214-2014-00537
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    May 1, 2014
    Report Date
    August 20, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2014, IT WAS REPORTED THE PATIENT EXPERIENCED SYMPTOMS OF HYPOACTIVE UPPER RIGHT OBLIQUE WITH MAXIMAL DIPLOPIA IN THE LOWER LEFT GAZE AND WAS ISSUED A PRESCRIPTION FOR PRISMATIC GLASSES. ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND STILL HAD VISUAL IMPAIRMENT. ON (B)(6) 2014, AN MRI REVEALED A CENTRAL LATERAL RIGHT CEREBELLUM ISCHEMIC LESION WHICH THE PHYSICIAN BELIEVES TO BE THE CAUSE OF THE VISUAL IMPAIRMENT. THE LOCATION OF THE LESION IS IN THE DURAL TENT FISTULA OF THE RIGHT CEREBELLUM.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVAL AS IT WAS CONSUMED IN THE EVENT. (B)(4).

    Description of Event or Problem · 1

    INFO RECEIVED FROM THE DAVF PROSPECTIVE REGISTRY, PT: (B)(6). TREATMENT OF A DAVF (DURAL ARTERIOVENOUS MALFORMATION). THE PT UNDERWENT ONYX EMBOLIZATION TREATMENT ON AN UNSPECIFIED DATE. ON (B)(6) 2014, IT WAS REPORTED THE PT HAD VISUAL IMPAIRMENT. THE TREATMENT WAS REPORTED TO BE ON-GOING. NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562980 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7000-060 9885175

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability