BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 9195027 · Received October 15, 2019

    Report

    Report Number
    2029214-2019-01026
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    November 8, 2018
    Report Date
    October 15, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONYX REMAINS IN THE PATIENT; PRODUCT ANALYSIS CANNOT BE PERFORMED. THE DEVICE WAS NOT RETURNED; THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KOCER, N., KANDEMIRLI, S. G., DASHTI, R., KIZILKILIC, O., HANIMOGLU, H., SANUS, G. Z., KAYNAR, M. Y. (2018). SINGLE-STAGE PLANNING FOR TOTAL CURE OF GRADE III¿V BRAIN ARTERIOVENOUS MALFORMATIONS BY EMBOLIZATION ALONE OR IN COMBINATION WITH MICROSURGICAL RESECTION. NEURORADIOLOGY, 61(2), 195¿205. DOI: 10.1007/S00234-018-2140-Z. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS DURING ONYX EMBOLIZATION. THE PURPOSE OF THIS ARTICLE WAS TO REPORT THE EXPERIENCE IN TREATING SPETZLER-MARTIN GRADE III-V BRAIN ARTERIOVENOUS MALFORMATIONS. THE AUTHORS REVIEWED THE RESULTS OF 31 PATIENTS; 18 WERE MALE AND 13 WERE FEMALE. CASE 1: THE PATIENT (FEMALE, 16 YEARS) PRESENTED WITH A GRADE 3, PARIETO-OCCIPITAL AVM. THE UNDERWENT ONYX EMBOLIZATION (4 VIALS) RE SULTING IN TOTAL EMBOLIZATION. THE PATIENT EXPERIENCED PARENCHYMAL HEMATOMA DURING EMBOLIZATION. FOLLOWING HEMATOMA EVACUATION AND NIDUS RESECTION, THE PATIENT HAD UPPER QUADRANTANOPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988122 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R