BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 4743730 · Received May 1, 2015

    Report

    Report Number
    2029214-2015-00490
    Event Type
    Injury
    Date Received
    May 1, 2015
    Date of Event
    December 1, 2007
    Report Date
    April 2, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/18077948. THIS REPORT WAS CREATED TO CAPTURE COMPLICATIONS RELATED TO ONYX FOR PATIENT 2. ONYX WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST PROCEDURE AND ITS CAUSE WAS UNKNOWN. INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFR: 2029214-2015-00489.

    Description of Event or Problem · 1

    CITATION: ANDREW P. CARLSON, ET AL. TREATMENT OF DURAL ARTERIOVENOUS FISTULA USING ETHYLENE VINYL ALCOHOL (ONYX) ARTERIAL EMBOLIZATION AS THE PRIMARY MODALITY: SHORT-TERM RESULTS. PUBLISHED IN J NEUROSURGE 107: 1120-1125, DECEMBER, 2007. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH REVIEW OF LITERATURE: A PATIENT PRESENTED WITH SUDDEN ONSET OF A SEVERE HEADACHE AND LEFT SIDE DYSMETRIA. HEAD COMPUTED TOMOGRAPHY (CT) SCANNING REVEALED A LEFT CEREBELLAR HEMATOMA AND SUBARACHNOID HEMORRHAGE. A MAGNETIC RESONANCE (MR) IMAGING STUDY REVEALED DILATED CEREBELLAR VEINS CONSISTENT WITH DURAL ARTERIOVENOUS FISTULA (DAVF). ANGIOGRAPHY CONFIRMED (DAVF) WITH A SINGLE FEEDING ARTERY FROM A POSTERIOR BRANCH OF THE MIDDLE MENINGEAL ARTERY (MMA). ARTERIAL CATHETERIZATION OF THIS VESSEL WAS PERFORMED, AND 0.4 ML OF ONYX WAS INJECTED INTO THE ARTERY JUST PROXIMAL TO THE (DAVF). THE FISTULA WAS COMPLETELY FILLED, AND INJECTION WAS STOPPED AT THE POINT OF REFLUX INTO THE FEEDING ARTERY. FOLLOW-UP ANGIOGRAPHY AT 9 WEEKS SHOWED COMPLETE OCCLUSION OF THE (DAVF). THE PATIENT'S HEADACHE RESOLVED AND HIS DYSMETRIA IMPROVED SIGNIFICANTLY, LEAVING HIM WITH ONLY A SMALL AMOUNT OF RESIDUAL INTENTION TREMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287391 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other