BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 4845816 · Received June 15, 2015

    Report

    Report Number
    2029214-2015-00682
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    December 16, 2010
    Report Date
    May 18, 2015
    Manufacturer
    IRVINE
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS IMPLANTED IN THE PATIENT; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. THE SECOND CASE FROM THIS ARTICLE WAS REPORTED IN MDR MFR# 2029214-2015-00682.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM LITERATURE REVIEW THAT DURING A TREATMENT OF A LARGE RIGHT SIDED JUVENILE NASOPHARYNGEAL ANGIOFIBROMA (JNA), THE PATIENT EXPERIENCE A TRIGOMINOCARDIAC REFLEX (TCR). A 20 GAUGE (G) SPINAL NEEDLE COMPATIBLE WITH ONYX WAS PLACED WITHIN THE TUMOR USING CT FLUOROSCOPY AVAILABLE IN THE HYBRID CT ANGIOGRAPHY SUITE. AFTER PUNCTURE, THE NEEDLE POSITION WAS CONFIRMED AS CORRECT WHEN BLOOD REFLUX FROM THE NEEDLE WAS SLOW BUT CONTINUOUS. A GENTLE HAND INJECTION OF CONTRAST WAS THEN PERFORMED THROUGH THE NEEDLE AND A BIPLANE PARENCHYMOGRAM WAS OBTAINED. THE TIP OF THE NEEDLE WAS POSITIONED CLOSE TO THE SKULL BASE, NEAR THE VICINITY OF THE FORAMEN OVALE. SUBSEQUENTLY, DMSO WAS INJECTED THROUGH THE NEEDLE TO PREVENT PREMATURE SOLIDIFICATION OF THE ONYX. THIS PRECIPITATED A SUDDEN ONSET OF ASYSTOLE AS WAS NOTIFIED BY THE ANESTHESIOLOGIST. THE PERCUTANEOUS INJECTION WAS STOPPED IMMEDIATELY AND 1 MG OF ATROPINE WAS ADMINISTERED INTRAVENOUSLY, RESTORING NORMAL HEART RATE AND RHYTHM AFTER APPROXIMATELY 30 S OF ASYSTOLE. FURTHER INJECTION OF DMSO FOLLOWED BY ONYX EMBOLIZATION DID NOT PRODUCE ANY ADDITIONAL ABNORMAL CARDIAC RESPONSES. THE PERCUTANEOUS EMBOLIZATION WITH ONYX WAS COMPLETED AND THE PATIENT UNDERWENT SURGICAL EXCISION OF THE TUMOR WITHIN 24 H, WITH GOOD RECOVERY.CITATION: POTTI TA, GEMMETE JJ, PANDEY AS, ET AL. TRIGOMINOCARDIAC REFLEX DURING THE PERCUTANEOUS INJECTION OF ETHYLENE VINYL ALCOHOL COPOLYMER (ONYX) INTO A JUVENILE NASOPHA RYNGEAL ANGIOFIBROMA: A REPORT OF TWO CASES. J NEUROINTERV SURG. 2011 SEP;3(3):263-5. DOI: 10.1136/JNIS.2010.003723. (HTTP://JNIS.BMJ.COM/CONTENT/3/3/263.LONG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388662 ONYX AGENT, INJECTABLE, EMBOLIC MFE IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other| R