BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 4524607 · Received February 18, 2015

    Report

    Report Number
    2029214-2015-00168
    Event Type
    Injury
    Date Received
    February 18, 2015
    Date of Event
    May 12, 2014
    Report Date
    January 22, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS CREATED TO CAPTURE THE EVENT OF WORSENING SYMPTOMS IN ONE OF THE PATIENTS FROM THE ARTICLE: LIU ET AL. CLINICAL APPROACH OF USING ONYX VIA TRANSARTERIAL ACCESS IN TREATING TENTORIAL DURAL ARTERIOVENOUS FISTULA. NEUROLOGICAL RESEARCH. 2014: 36(11) 983-991. THE DEVICE WILL NOT BE REUTRNING FOR EVALUATION.(B)(4)

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: LIU ET AL. CLINICAL APPROACH OF USING ONYX VIA TRANSARTERIAL ACCESS IN TREATING TENTORIAL DURAL ARTERIOVENOUS FISTULA. NEUROLOGICAL RESEARCH. 2014: 36(11) 983-991. MEDTRONIC (COVIDIEN) RECEIVED INFORMATION REGARDING A PRODUCT AND ADVERSE EVENT. POST EMBOLIZATION TREATMENT, IT WAS REPORTED A PATIENT THE PATIENT¿S CRANIAL NERVE SYMPTOMS WORSENED EVEN THOUGH THE TDAVF (TENTORAL DUAL ARTERIOVENOUS FISTULA) WAS SUB-TOTALLY OBLITERATED. THE PATIENT¿S SYMPTOMS SIGNIFICANTLY ALLEVIATED AND THE PATIENT WAS DISCHARGED. THE ARTICLE¿S OBJECTIVE WAS AN ATTEMPT TO INVESTIGATE THE POSSIBILITY TO DO TRANSARTERIAL EMBOLIZATION USING ONYX TO TREAT TENTORIAL DURAL ARTERIOVENOUS FISTULA (TDAVF). CLINICAL AND RADIOLOGICAL DATA OF 26 PATIENTS WHO HAD TDAVFS TREATED VIA THE TRANSARTERIAL APPROACH WERE RETROSPECTIVELY REVIEWED. IT WAS CONCLUDED THAT TREATING THE TDAVF VIA TRANSARTERIAL APPROACH USING ONYX MAYBE A FEASIBLE CLINICAL PRACTICE. THE FISTULA OBLITERATED RATE IS HIGHLY RELATED TO THE ANATOMIC CHARACTERISTIC, AND HIGH COMPLETE OBLITERATED RATE CAN BE ACHIEVED. ALSO ONYX INJECTION WITH BALLOON ASSISTANCE CAN BE HELPFUL IN SOME OF THE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116788 ONYX AGENT, INJECTABLE,, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other