BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, ANEURYSM

    MDR report key: 1040022 · Received May 7, 2008

    Report

    Report Number
    2029214-2008-00087
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 9, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS IMPLANTED IN THE PT.

    Description of Event or Problem · 1

    EMBOLIZATION TREATMENT OF AN AVM LOCATED NEAR THE OPHTHALMIC ARTERY WITH ONYX. POST PROCEDURE, IT WAS REPORTED THE PATIENT WOKE UP AND EXPERIENCED BLURRY VISION. POST PROCEDURAL ANGIOGRAMS SHOWED NO EVIDENCE OF OCCLUSIONS IN THE OPHTHALMIC ARTERY. POST PROCEDURAL RETINAL EXAMS SHOWED DISTAL RETINAL ARTERY OCCLUSIONS WHICH WERE REPORTED AS THE CAUSE OF THE VISUAL SYMPTOMS. SUBSEQUENTLY, IT WAS REPORTED THE PATIENT'S VISUAL PROBLEMS HAVE RESOLVED. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX, ANEURYSM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-8101-500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability