BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 10304487 · Received July 21, 2020

    Report

    Report Number
    2029214-2020-00710
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    April 12, 2019
    Report Date
    July 21, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED EVENT DETAILS, THERE WAS NO DIRECT ALLEGATION OF A DEVICE MALFUNCTION. THE ADVERSE EVENTS THAT OCCURRED ARE KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). LINKED MDR: 2029214-2020-00709. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MA, Y., ZHANG, Y., JIANG, J., LI, S., NI, T., LIU, L., XUE, Z., WU, C., SUN, Z., <(>&<)> YU, X. (2019). APPLICATION AND RELIABILITY OF THE SUPERSELECTIVE BALLOON OCCLUSION TEST IN THE TREATMENT OF COMPLEX CEREBRAL ARTERY ANEURYSMS: A REPORT OF 12 CASES. JOURNAL OF CLINICAL NEUROSCIENCE, 64, 57¿63. OUR GROUP OF PATIENTS INCLUDED 8 MEN AND 4 WOMEN. THEIR AGE RANGED FROM 17 TO 59 YEARS (AVERAGE: 40.8 YEARS). HYPERFORM AND HYPERGLIDE WERE THE BALLOONS USED IN THESE CASES. SLIGHT NEUROLOGICAL DYSFUNCTION OCCURRED IN PATIENTS 2 AND 9 AFTER PARENT ARTERY SACRIFICE (PAS) BY ENDOVASCULAR TREATMENT USING A COIL OR AN ONYX LIQUID EMBOLIC AGENT. HOWEVER, THE BALLOON OCCLUSION TEST (BOT) RESULTS OF PATIENTS 2 AND 9 WERE NEGATIVE POSSIBLY BECAUSE SOME OF THE SMALL CORTICAL ARTERIES WERE OCCLUDED BY THE ONYX DURING THE PAS PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766058 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other