BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4743947 · Received May 1, 2015

    Report

    Report Number
    2029214-2015-00492
    Event Type
    Injury
    Date Received
    May 1, 2015
    Date of Event
    May 1, 2012
    Report Date
    April 2, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PMC/ARTICLES/PMC3467794/. THIS REPORT WAS CREATED TO CAPTURE THE COMPLICATIONS RELATED TO THE ONYX. THE 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. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT PROVIDED. (B)(4). INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFRS: 2029214-2015-00493; 2029214-2015-00491. NOTE: THE PROCEDURE DESCRIBED IN THIS REPORT REQUIRED OFF-LABEL USE OF ONYX.

    Description of Event or Problem · 1

    CITATION. PETER ADAMCZYK, ET AL. RECURRENCE OF "CURED" DURAL ARTERIOVENOUS FISTULAS AFTER ONYX EMBOLIZATION. DEPARTMENT OF NEUROLOGICAL SURGERY, KECK SCHOOL OF MEDICINE, UNIVERSITY OF SOUTHERN CALIFORNIA, LOS ANGELES, CALIFORNIA. NEUROSURG FOCUS 32 (5):E12, 2012. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH REVIEW OF LITERATURE: A PATIENT PRESENTED WITH HEADACHE AND TINNITUS RELATED TO A DURAL ARTERIOVENOUS (DAVF) IN THE LEFT SPHENOID WING WAS TREATED WITH ONYX 18 THROUGH A SINGLE PEDICLE IN THE LEFT MIDDLE MENINGEAL ARTERY. PERMEATION OF THE ONYX INTO THE FISTULA AND AN EARLY COMPONENT OF THE DRAINING VEIN WAS NOTED WITH COMPLETE OCCLUSION OF THE FISTULA ON POSTTREATMENT ANGIOGRAPHY. THE PATIENT'S SYMPTOMS RESOLVED IMMEDIATELY AFTERWARD, AND SHE REMAINED ASYMPTOMATIC. HOWEVER, FOLLOWUP MR ANGIOGRAPHY OF THE BRAIN PERFORMED 1.5 YEARS LATER SUGGESTED POSSIBLE (DAVF) RECURRENCE. REPEAT ANGIOGRAPHY WAS SUBSEQUENTLY PERFORMED, CONFIRMING THE PRESENCE OF THE DAVF IN THE SAME LOCATION. THE DAVF WAS AGAIN FED BY THE LEFT MIDDLE MENINGEAL ARTERY WITH DRAINAGE VIA THE SAME VEINS, DISTAL TO THE PREVIOUSLY PLACED EMBOLIC MATERIAL. REPEAT EMBOLIZATION WAS PERFORMED USING NBUTYL CYANOACRYLATE (NBCA) THROUGH A LEFT MIDDLE MENINGEAL PEDICLE WITH REDUCTION OF (DAVF) FILLING. FURTHER ANGIOGRAPHY REVEALED ALTERNATE FILLING OF THE (DAVF) VIA SMALL ETHMOIDAL BRANCHES OF THE LEFT OPHTHALMIC ARTERY. THE REMAINDER OF THE FISTULA WAS DEEMED UNSUITABLE FOR EMBOLIZATION DUE TO THE SIGNIFICANT RISK OF POTENTIALLY INCURRING LEFT VISION LOSS. THE PATIENT REMAINED ASYMPTOMATIC AND DEFERRED ADDITIONAL TREATMENT OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287943 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7100-060

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention