BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 5196319 · Received November 2, 2015

    Report

    Report Number
    2029214-2015-05078
    Event Type
    Injury
    Date Received
    November 2, 2015
    Report Date
    October 8, 2015
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
    Product Code
    MFE
    PMA / PMN Number
    PMA P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007%2FS00270-015-1062-Y THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL SERIOUS ADVERSE EVENTS FROM THIS ARTICLE WERE CAPTURED IN THIS REPORT. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE IMPLANTED IN THE PATIENT; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. FUNCTIONAL NEUROLOGICAL DEFICIT IS A KNOWN INHERENT RISK OF ONYX PROCEDURE AND IS DOCUMENTED IN THE ONYX INSTRUCTION FOR USE (IFU). ADDITIONNALY, THE ONYX IFU PROVIDES ADEQUATE INSTRUCTION, "INJECT ONYX¿ LES AND DMSO AT A SLOW, STEADY RATE, NOT TO EXCEED 0.3 ML/MINUTE. ANIMAL STUDIES HAVE SHOWN THAT A RAPID INJECTION OF DMSO INTO THE VASCULATURE MAY LEAD TO VASOSPASM AND/OR ANGIONECROSIS."

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM LITERATURE REVIEW THAT THESE COMPLICATIONS OCCURRED DURING AND POST EMBOLIZATION OF CAVERNOUS DURAL ARTERIOVENOUS FISTULAS (CDAVFS) WITH ONYX: 1. THREE PATIENTS HAD TRANSIENT BRADYCARDIA DURING THE ONYX INJECTION. 2. ONE PATIENT EXPERIENCED DELAYED OPHTHALMOPLEGIA DUE TO CRANIAL NERVE (CN) VI PALSY WITH A TIME LAG OF 3 MONTHS AFTER TRANSVENOUS EMBOLIZATION (TVE). THE PATIENT WAS TREATED WITH COILS FIRST AND THEN EMBOLIZATION USING ONYX. THE DELAYED CNVI PALSY IMPROVED SIGNIFICANTLY, BUT WAS NOT COMPLETELY RESOLVED DURING THE LATER CLINICAL FOLLOW UP. THE AUTHORS REPORTED A RETROSPECTIVE STUDY OF A SERIES OF FORTY-ONE PATIENTS WITH CDAVFS WERE TREATED WITH TVE IN THEIR DEPARTMENT BETWEEN APRIL 2009 AND OCTOBER 2013. FOR EACH PATIENT, CLINICAL AND RADIOLOGIC RECORDS WERE RETROSPECTIVELY REVIEWED AND EVALUATED, WITH AN EMPHASIS PLACED ON EVALUATING THE OUTCOMES OF THE PRE-EXISTING CDAVF-INDUCED CRANIAL NERVE DYSFUNCTION (CND) AND THE TVE-INDUCED CND. THE AUTHORS CONCLUDED THAT BOTH THE PRE-EXISTING CDAVF-INDUCED CND AND THE TVE-INDUCED NEW OR AGGRAVATED CND COMPLETELY RESOLVED IN ALMOST ALL CASES AFTER EMBOLIZATION WITH ONYX. CITATION: LI C, WANG Y, LI Y, ET AL. CRANIAL NERVE DYSFUNCTION ASSOCIATED WITH CAVERNOUS DURAL ARTERIOVENOUS FISTULAS AFTER TRANSVENOUS EMBOLIZATION WITH ONYX. CARDIOVASC INTERVENT RADIOL. 2015 OCT;38(5):1162-70. DOI: 10.1007/S00270-015-1062-Y.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724654 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention