BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6450655 · Received March 31, 2017

    Report

    Report Number
    2029214-2017-00336
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    April 6, 2012
    Report Date
    November 16, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AS IT WAS CONSUMED IN THE PROCEDURE. ATTEMPTS HAVE BEEN MADE TO OBTAIN SPECIFIC INFORMATION, HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. VARIOUS FUNCTIONAL NEUROLOGICAL DEFICITS (FACIAL NERVE PALSY) ARE A KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE PRODUCT WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT AND ITS CAUSED WAS UNKNOWN. MDR RELATED TO THIS EVENT: 2029214-2017-00333, 2029214-2017-00334, 2029214-2017-00335, 2029214-2017-00336, 2029214-2017-00337, 2029214-2017-00338, 2029214-2017-00339, 2029214-2017-00340, 2029214-2017-00341. 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

    CITATION: ONYX VERSUS N-BCA FOR EMBOLIZATION OF CRANIAL DURAL ARTERIOVENOUS FISTULAS. RABINOV JD1, YOO AJ, OGILVY CS, CARTER BS, HIR SCH JA. J NEUROINTERV SURG. 2013 JUL;5(4):306-10. DOI: 10.1136/NEURINTSURG-2011-010237. EPUB 2012 MAY 1. MEDTRONIC RECEIVED THE FOLLOWING REPORT: PATIENT 2 (MALE, AGE RANGE 70-79 YEARS) WAS REPORTED TO HAVE FACIAL NERVE PALSY FOLLOWING EMBOLIZATION OF THE PETROUS BRANCH OF THE RIGHT MIDDLE MENINGEAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232930 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability