BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 7036034 · Received November 15, 2017

    Report

    Report Number
    2029214-2017-01262
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    June 14, 2017
    Report Date
    November 15, 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

    JIN, H., LIU, Z., CHANG, Q., CHEN, C., GE, H., LV, X., <(>&<)> LI, Y. (2017). A CHALLENGING ENTITY OF ENDOVASCULAR EMBOLIZATION WITH ONYX FOR BRAINSTEM ARTERIOVENOUS MALFORMATION: EXPERIENCE FROM 13 CASES. INTERVENTIONAL NEURORADIOLOGY, 159101991771167. DOI:10.117 7/1591019917711679 THE ONYX WAS CONSUMED DURING THE PROCEDURES AND REMAINS IN THE PATIENT; PRODUCT ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION PROVIDED IN THE ARTICLE, THE POST-PROCEDURE COMPLICATIONS DO NOT APPEAR TO BE RELATED TO A DEFECT OF THE ONYX. THE INFORMATION PROVIDED SUGGESTS THAT THIS EVENT WAS PROCEDURE-RELATED. MDRS RELATED TO THIS ARTICLE: 2029214-2017-00915 2029214-2017-00916 2029214-2017-00917 2029214-2017-01261 2029214-2017-01262 2029214-2017-01263 2029214-2017-01264 2029214-2017-01265.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF PATIENT COMPLICATIONS AFTER ONYX EMBOLIZATION. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT THE EXPERIENCE OF ONYX EMBOLIZATION OF BRAINSTEM ARTERIOVENOUS MALFORMATIONS (AVMS). THE AUTHORS REVIEWED 13 PATIENTS WHO UNDERWENT 14 ONYX EMBOLIZATION PROCEDURES TO TREAT BRAINSTEM AVM. OF THE PATIENTS, 8 WERE MALE AND 5 WERE FEMALE; THE MEAN AGE WAS 29.9 YEARS. PATIENT NO. 11 PRESENTED WITH HEMORRHAGE AND UNDERWENT ONYX EMBOLIZATION OF A 10MM POSTERIOR PONS AVM. ONYX EMBOLIZATION RESULTED IN COMPLETE OCCLUSION OF THE AVM. THE PATIENT REPORTEDLY EXPERIENCED HEMIPLEGIA AND ATAXIA CAUSED BY LESIONS OF THE PONS TEGMENTUM. THE PATIENT¿S INITIAL MRS WAS 4. THREE MONTHS POST-PROCEDURE, THE PATIENT¿S MRS WAS 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814033 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7000-060 A130551

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other