BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 4519564 · Received February 16, 2015

    Report

    Report Number
    2029214-2015-00151
    Event Type
    Injury
    Date Received
    February 16, 2015
    Report Date
    January 19, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    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 POST PROCEDURE COMPLICATION OF VISION IMPAIRMENT IN ONE PATIENT FROM THE ARTICLE: LIU ET AL. ONYX EMBOLIZATION OF CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULAS VIA DIRECT TRANSORBITAL PUNCTURE UNDER THE GUIDANCE OF THREE-DIMENSIONAL RECONSTRUCTED SKULL IMAGE (REPORTS OF SIX CASES). ACTA NEUROCHIR (2014) 156:897-900. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: LIU ET AL. ONYX EMBOLIZATION OF CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULAS VIA DIRECT TRANSORBITAL PUNCTURE UNDER THE GUIDANCE OF THREE-DIMENSIONAL RECONSTRUCTED SKULL IMAGE (REPORTS OF SIX CASES). ACTA NEUROCHIR (2014) 156:897-900. SIX PATIENTS UNDERWENT ONYX EMBOLIZATION TREATMENT VIA DIRECT PUNCTURE OF THE TRANSORBITAL BONE AND THEY ALL EXPERIENCED A RETROBULBAR HEMATOMA AND EYE SWELLING RIGHT AFTER EMBOLIZATION, WHILE THE SWELLING SIGNIFICANTLY SUBSIDED AFTER 3-5 DAYS OF CONSERVATIVE TREATMENT. ONE 49 YEAR OLD MALE EXPERIENCE DECREASED VISUAL ACUITY OF THE RIGHT EYE AND PATIENT HAD NO IMPROVEMENT IN VISUAL ACUITY AT SIX MONTH FOLLOW-UP. THE PERMANENT VISION LOSS WAS ATTRIBUTED TO OPTIC NERVE DAMAGE CAUSED BY LACK OF EXPERIENCE. THE ARTICLE REPORTS THAT USING THE VENOUS PATHWAY IS NOT FEASIBLE FOR SOME CAVERNOUS DURAL ARTERIOVENOUS FISTULAS DUE TO THE COMPLEX ANGIOARCHITECTURE AND THAT ONYX EMBOLIZATION VIA DIRECT TRANSORBITAL PUNCTURE PROVIDES A METHOD TO BE CONSIDERED TO TREAT CS DAVFS WHEN THE CONVENTIONAL TRANSVENOUS APPROACHES ARE INACCESSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111106 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability