BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 10458020 · Received August 26, 2020

    Report

    Report Number
    2029214-2020-00851
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    April 1, 2020
    Report Date
    August 26, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CATAPANO, JOSHUA S., RAMI O. ALMEFTY, DALE DING, ALEXANDER C. WHITING, ANDREW R. PINES, KENT R. RICHTER, ANDREW F. DUCRUET, AND FELIPE C. ALBUQUERQUE. 2020. ¿ONYX EMBOLIZATION OF SKULL BASE PARAGANGLIOMAS: A SINGLE-CENTER EXPERIENCE.¿  ACTA NEUROCHIRURGICA 162 (4): 821¿29. DOI:10.1007/S00701-019-04127-5. MEDTRONIC RECEIVED AN ARTICLE PERTAINING TO A STUDY OF PATIENTS WITH SKULL BASE PARAGANGLIOMAS WHO UNDERWENT PREOPERATIVE ONYX EMBOLIZATION FROM JANUARY 01, 2005 TO DECEMBER 31, 2017. SEVEN PATIENTS WERE STUDIED, 6 WITH GLOMUS JUGULARES AND 1 WITH A GLOMUS VAGALE. THE ONLY POSTEMBOLIZATION COMPLICATION WAS A FACIAL PALSY, CN VIII DEFICIT IN A 52 YEAR OLD MALE PATIENT WITH A LEFT JUGULARE PARAGANGLIOMAS THAT HAD A MAX DIAMETER OF 4MM. THE PATIENT'S STATUS AT 7.5 MONTH FOLLOW UP WAS NOT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916929 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other