BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6450610 · Received March 31, 2017

    Report

    Report Number
    2029214-2017-00333
    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
    PMA / PMN Number
    P030004
    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 MAY HAVE BEEN CONSUMED IN THE PROCEDURE. 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN SPECIFIC INFORMATION, HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. PER THE PRODUCTS INSTRUCTIONS FOR USE, INJECT 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. 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 2029214-2017-00341BLE. 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 1 (MALE, AGE RANGE 50-59 YEARS) WAS REPORTED TO HAVE ASYSTOLIC EVENT, THIS PATIENT WAS TREATED FOR A POSTERIOR FOSSA LESION. THE AUTHOR POSTULATE THAT THIS COULD HAVE BEEN RELATED TO DIMETHYL SULFOXIDE (DMSO) ADMINISTRATION INTO THE LEFT POSTERIOR INFERIOR CEREBELLAR ARTERY SUPPLYING THE DURAL ARTERIOVENOUS FISTULAS (DAVF) IN PROXIMITY TO THE FLOOR OF THE FOURTH VENTRICLE. THE PROCEDURE WAS TERMINATED AND THE PATIENT WAS CLINICALLY ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233449 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other