BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 4845836 · Received June 15, 2015

    Report

    Report Number
    2029214-2015-00683
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    December 16, 2010
    Report Date
    May 18, 2015
    Manufacturer
    COVIDIEN (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

    (B)(4). OFF-LABEL USE: PER ONYX INSTRUCTION FOR USE THE INDICATION FOR USE IS PRESURGICAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS (BAVMS). THE EVENT OCCURED DURING A PRESURGICAL EMBOLIZATION OF A JUVENILE NASOPHARYNGEAL ANGIOFIBROMA (JNA). THE FIRST CASE FROM THE SAME ARTICLE WAS REPORTED IN MDR MFR# 2029214-2015-00682.

    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.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM LITERATURE REVIEW THAT DURING A TREATMENT OF OF A JUVENILE NASOPHARYNGEAL ANGIOFIBROMA (JNA), THE PATIENT EXPERIENCE A TRIGEMINOCARDIAC REFLEX THAT OCCURRED SUDDENLY AFTER THE INJECTION OF DIMETHYLSULFOXIDE (DMSO) AND WAS MANAGED BY ADMINISTERING ANTICHOLINERGIC DRUGS. THE PATIENT UNDERWENT PERCUTANEOUS EMBOLIZATION OF HIS JNA BEFORE SURGICAL EXCISION. GENERAL ANESTHESIA WAS USED AND A 20G NEEDLE PLACED INTO THE JNA WITH THE AID OF CT FLUOROSCOPY. DURING THE INJECTION OF DMSO THROUGH THE NEEDLE, THIS PATIENT EXPERIENCED SEVERE BRADYCARDIA WITH A HEART RATE OF 20-30 BPM THAT ALSO LASTED FOR ABOUT 30S. IN THIS CASE, INTRAVENOUS GLYCOPYRROLATE WAS ADMINISTERED, WITH RESOLUTION OF THE PATIENT'S SYMPTOMS. THERE WERE NO ABNORMAL CARDIAC RESPONSES FOR THE REMAINDER OF THE PROCEDURE. FOLLOWING THE PERCUTANEOUS EMBOLIZATION, THE PATIENT SUBSEQUENTLY UNDERWENT SURGICAL EXCISION OF HIS JNA WITH GOOD RECOVERY. POTTI TA, GEMMETE JJ, PANDEY AS, ET AL. TRIGEMINOCARDIAC REFLEX DURING THE PERCUTANEOUS INJECTION OF ETHYLENE VINYL ALCOHOL COPOLYMER (ONYX) INTO A JUVENILE NASOPHARYNGEAL 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
    387481 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other| R