BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 10002390 · Received April 27, 2020

    Report

    Report Number
    2029214-2020-00401
    Event Type
    Injury
    Date Received
    April 27, 2020
    Report Date
    April 27, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFORMATION WITHIN THE ARTICLE IT COULD NOT BE DETERMINED WHAT LIQUID EMBOLIC WAS USED TO TREAT EACH PATIENT. SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS AND THE EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. LINKED WITH MDR: 2029214-2020-00400. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    OPER NEUROSURG (HAGERSTOWN). 2019 NOV 1;17(5):503-508. DOI: 10.1093/ONS/OPZ028. NEUROPHYSIOLOGICAL MONITORING DURING ARTERIOVENOUS MALFORMATION EMBOLIZATION. EPHRAIM W. CHURCH, PRATIK ROHATGI, AMY E. FEIDT, PAUL KALAPOS, KEVIN M. COCKROFT A MARATHON OR APOLLO MICROCATHETER WAS USED THROUGH A 6F ENVOY GUIDING CATHETER (DEPUY SYNTHES, (B)(4)). IN CASES OF TORTUOUS ANATOMY, OUR USUAL GUIDING SYSTEM WAS AN 058 NAVIEN (MEDTRONIC) PLACED WITHIN A 6F SHUTTLE (COOK). EMBOLIC MATERIALS WERE ETHYLENE VINYL ALCOHOL COPOLYMER (ONYX, MEDTRONIC), N-BUTYL CYANOACRYLATE (NBCA, TRUFILL, DEPUY SYNTHES), OR A COMBINATION OF THESE. THE PROCEDURAL GOAL WAS EMBOLIZATION AS TREATMENT ADJUNCT (HIGH-RISK FEATURE, FACILITATE MICROSURGICAL RESECTION, ETC) AS OPPOSED TO CURE. THERE WERE 74 PATIENTS. MEAN AGE WAS 40 YR (RANGE 7-78). THERE WERE 31 MALES AND 43 FEMALES. ONYX IN 104 (65%) CASES, NBCA IN 45 (28%) CASES, AND BOTH ONYX AND NBCA IN 11 (7%) CASES. 2 HAD PERMANENT NEUROLOGICAL DEFICITS FOLLOWING EMBOLIZATION. THERE WAS 1 CASE OF REFLUX INTO THE VERTEBRAL ARTERY. THREE PATIENTS HAD NPM CHANGES AND HAD A POSTOPERATIVE NEUROLOGICAL DEFICIT. THESE INCLUDED RIGHT UPPER EXTREMITY SSEP CHANGE WITH RIGHT FACIAL AND ARM WEAKNESS, RIGHT SSEP CHANGE WITH RIGHT HEMIPARESIS AND EXPRESSIVE APHASIA, AND LEFT BAER CHANGE WITH LEFT HEARING LOSS. THREE PATIENTS HAD NPM CHANGES WITHOUT NEUROLOGICAL DEFICITS, AND 7 PATIENTS HAD NO NPM CHANGES BUT DID DEVELOP A POSTOPERATIVE NEUROLOGICAL DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466096 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other