BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6737727 · Received July 24, 2017

    Report

    Report Number
    2029214-2017-00915
    Event Type
    Injury
    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. FROM THE INFORMATION PROVIDED IN THE ARTICLE, THE POST-PROCEDURE PATIENT COMPLICATIONS DO NOT APPEAR TO BE RELATED TO A DEFECT OF THE ONYX. THE INFORMATION PROVIDED SUGGESTS THAT THESE EVENTS WERE PROCEDURE-RELATED. MDRS RELATED TO THIS ARTICLE: 2029214-2017-00915 2029214-2017-00916 2029214-2017-00917.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER, EXPIRATION DATE, LOT NUMBER - ADDITIONAL INFORMATION. MANUFACTURED DATE - ADDITIONAL INFORMATION. ADDITIONAL MANUFACTURER NARRATIVE - ADDITIONAL INFORMATION. THE INFORMATION PROVIDED IN MODEL #/LOT # AND DEVICE MANUFACTURE DATE CORRESPONDS TO PATIENT 7. ADDITIONAL MDRS WILL BE SUBMITTED TO REPORT INFORMATION CORRESPONDING TO PATIENTS 10 AND 11. 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 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. THE ARTICLE STATES THAT THE FOLLOWING PATIENTS EXPERIENCED COMPLICATIONS AFTER ONYX EMBOLIZATION: PATIENT NO. 7 (MALE, (B)(6)) PRESENTED WITH HEMORRHAGE AND UNDERWENT ONYX EMBOLIZATION OF A 35MM POSTERIOR MIDBRAIN AVM. ONYX RESULTED IN NEAR-COMPLETE OCCLUSION OF THE AVM. THE PATIENT EXPERIENCED POST-OPERATIVE HEMORRHAGIC COMPLICATION THAT WAS CAUSED BY NEAR-COMPLETE OBLITERATION OF THE AVM AND STENOSIS OF THE DRAINING VEIN. THE PATIENT¿S INITIAL MRS WAS 3. AS OF 50 MONTHS POST-PROCEDURE, THE PATIENT¿S MRS WAS 3. PATIENT NO. 10 (MALE, (B)(6)) PRESENTED WITH HEMORRHAGE AND UNDERWENT ONYX EMBOLIZATION OF A 32MM ANTERIOR MIDBRAIN AVM. ONYX RESULTED IN PARTIAL OCCLUSION OF THE AVM. THE PATIENT EXPERIENCED A VENTRAL MESENCEPHALIC INFARCTION FROM PERFORATING ARTERIES OCCLUSION. AS A RESULT, THE PATIENT EXPERIENCED HEMIPLEGIA AND OCULOMOTOR NERVE PARALYSIS. FOLLOW-UP FOR THIS PATIENT IS NOT AVAILABLE. PATIENT NO. 11 (MALE, (B)(6)) 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
    516580 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7000-060 6886746

    Patients

    Seq Age Sex Outcome Treatment
    1 Other