BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6442898 · Received March 29, 2017

    Report

    Report Number
    2029214-2017-00263
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    August 17, 2010
    Report Date
    March 3, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EUROPEAN JOURNAL OF RADIOLOGY CITATION: THE LIMITATIONS AND RISKS OF TRANSARTERIAL ONYX INJECTIONS IN THE TREATMENT OF GRADE I AND II DAVFS. XIANLI LV, CHUHAN JIANG, YOUXIANG LI, ET AL. THE DEVICE 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR OF THIS ARTICLE REGARDING THIS CASE. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS RELATED TO THIS EVENT: 2029214-2017-00263 2029214-2017-00264 2029214-2017-00265 2029214-2017-00266 2029214-2017-00267. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION DURING LITERATURE REVIEW THAT ONE PATIENT WITH AN INFERIOR PETROSAL SINUS FISTULA DEMONSTRATED REFLEXIVE BRADYARRYTHMIA, WHICH MAY BE CAUSED BY TRIGEMINO-CARDIAC REFLEX, DURING ONYX INJECTION VIA THE MIDDLE MENINGEAL ARTERY (MMA). THIS REFLEX WAS RESOLVED WITH AN INTRAVENOUS BOLUS OF ATROPINE. THE PATIENT ALSO EXPERIENCED TRANSIENT FIFTH NERVE DYSFUNCTION AFTER MMA EMBOLIZATION. THIS PROBLEM LASTED FROM 2 TO 4 MONTHS. THIS ARTICLE RETROSPECTIVELY STUDIED 26 CONSECUTIVE PATIENTS (8 WOMEN AND 18 MEN) TREATED FOR AN GRADE I AND II INTRACRANIAL DURAL ANTERIOR VENOUS FISTULAS (DAVFS) SINCE 2006 IN WHOM A TRANSARTERIAL APPROACH WAS ATTEMPTED WITH ONYX-18 EMBOLIZATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227169 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7000-060 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention