BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX AVM

    MDR report key: 7036040 · Received November 15, 2017

    Report

    Report Number
    2029214-2017-01265
    Event Type
    Death
    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., AND 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 PATIENTS; PRODUCT ANALYSIS CANNOT BE PERFORMED. THE EVENTS COULD NOT BE CONFIRMED. THE INFORMATION PROVIDED IN THE ARTICLE IS NOT ENOUGH TO CONCLUSIVELY DETERMINE THE CAUSE OF THE PATIENTS' COMPLICATIONS AND SUBSEQUENT DEATHS. 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 AND DEATH 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. 12 PRESENTED WITH HEMORRHAGE AND UNDERWENT ONYX EMBOLIZATION OF A 25MM POSTERIOR PONS AVM. ONYX EMBOLIZATION RESULTED IN PARTIAL OCCLUSION OF THE AVM. THE PATIENT EXPERIENCED HEMIPLEGIA AND ATAXIA CAUSED BY LESIONS OF THE PONS TEGMENTUM. THIRTEEN MONTHS POST-PROCEDURE, THE PATIENT DIED OF INTRACRANIAL HEMORRHAGE THAT WAS CAUSED BY RUPTURE OF RESIDUAL NIDUS OF THE POSTERIOR PONTINE AVM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814235 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7000-060 9456134

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death