BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 6737742 · Received July 24, 2017

    Report

    Report Number
    2029214-2017-00917
    Event Type
    Death
    Date Received
    July 24, 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 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. 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

    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. 1 (MALE, (B)(6) YEARS) PRESENTED WITH HEMORRHAGE AND UNDERWENT ONYX EMBOLIZATION FOR A 30MM POSTERIOR MIDBRAIN AVM. ONYX WAS ABLE TO PARTIALLY OCCLUDE THE AVM. DURING THE PERIOPERATIVE PERIOD, THE PATIENT EXPERIENCED OCCLUSION OF THE POSTERIOR CEREBRAL ARTERY (PCA, FEEDING ARTERY). THE ARTICLE STATES THAT VESSEL OCCLUSION WAS CAUSED BY EXCESSIVE REFLUX OF ONYX. THE PATIENT EXPERIENCED ACUTE BRAINSTEM INFARCTION AND PASSED AWAY. PATIENT NO. 12 (FEMALE, (B)(6) YEARS) 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. PATIENT NO. 13 (MALE, (B)(6) YEARS) PRESENTED WITH HEMORRHAGE AND UNDERWENT ONYX EMBOLIZATION OF A 30MM ARTERIOR MEDULLARY AVM. ONYX RESULTED IN PARTIALLY OCCLUSION OF THE AVM. THERE WAS EXCESSIVE REFLUX DURING THE PROCEDURE, WHICH CAUSED VESSEL OCCLUSION. IN ADDITION, IT WAS NOTED THAT THERE WAS DIFFICULTY RETRIEVING THE DISTAL PART OF THE MARATHON CATHETER, WHICH WAS ENTRAPPED AFTER INJECTING ONYX INTO THE TORTUOUS FEEDING ARTERY. THE DISTAL PART OF THE MARATHON WAS RETAINED. DURING THE PERIOPERATIVE PERIOD, THE PATIENT EXPERIENCED ACUTE CENTRAL MEDULLARY INFARCTION AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516704 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7000-060 9575472

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O