BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4744455 · Received May 1, 2015

    Report

    Report Number
    2029214-2015-00491
    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 COMPLICATIONS RELATED TO ONYX. 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 REPORTED. INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFRS: 2029214-2015-00493, 2029214-2015-00492. (B)(4). 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: EMBOLIZATION OF A DURAL ARTERIOVENOUS FISTULA (DAVF) WAS PERFORMED ON A PATIENT USING ONYX18 WITH SUFFICIENT PENETRATION AND CASTING OF ONYX INTO THE FISTULA. FINAL ANGIOGRAPHY REVEALED NO EVIDENCE OF EARLY VENOUS DRAINAGE OR FILLING OF THE FISTULA. THE PATIENT'S SYMPTOMS GRADUALLY IMPROVED, BUT REPEAT ANGIOGRAPHY PERFORMED 7 MONTHS LATER REVEALED (DAVF) RECURRENCE. CATHETERIZATION OF THE L2 LUMBAR SEGMENTAL ARTERY DEMONSTRATED FILLING OF THE FISTULA FROM COLLATERALIZATION INTO AN L3 RADICULAR BRANCH UNDER THE L3 PEDICLE. DRAINAGE OF THE FISTULA REMAINED THE SAME VIA A SLOWFLOWING VEIN. REPEAT EMBOLIZATION COULD NOT BE PERFORMED DUE TO THE LACK OF MICROCATHETER ACCESS TO THE FISTULOUS SITE. THEREFORE, OPEN NEUROSURGICAL LIGATION OF THE FISTULA WAS PERFORMED 2 MONTHS LATER. EXPOSURE OF THE FISTULA DURING SURGERY ESTABLISHED THE CONTINUED PRESENCE OF AN ONYX CAST INTO THE PROXIMAL SEGMENT OF THE DRAINING VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287738 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7100-060

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention