BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 14593928 · Received June 3, 2022

    Report

    Report Number
    2029214-2022-00938
    Event Type
    Death
    Date Received
    June 3, 2022
    Date of Event
    July 17, 2020
    Report Date
    June 3, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOYCE, E., BOUNAJEM, M. T., SCOVILLE, J., THOMAS, A. J., OGILVY, C. S., RIINA, H. A., TANWEER, O., LEVY, E. I., SPIOTTA, A. M., GROSS, B. A., JANKOWITZ, B. T., CAWLEY, C. M., KHALESSI, A. A., PANDEY, A. S., RINGER, A. J., HANEL, R., ORTIZ, R. A., LANGER, D., LEVITT, M. R., GRANDHI, R. (2020). MIDDLE MENINGEAL ARTERY EMBOLIZATION TREATMENT OF NONACUTE SUBDURAL HEMATOMAS IN THE ELDERLY: A MULTIINSTITUTIONAL EXPERIENCE OF 151 CASES. NEUROSURGICAL FOCUS, 49(4). HTTPS://DOI.ORG/10.3171/2020.7.FOCUS20518. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT P ROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    JOYCE, E., BOUNAJEM, M. T., SCOVILLE, J., THOMAS, A. J., OGILVY, C. S., RIINA, H. A., TANWEER, O., LEVY, E. I., SPIOTTA, A. M., GROSS, B. A., JANKOWITZ, B. T., CAWLEY, C. M., KHALESSI, A. A., PANDEY, A. S., RINGER, A. J., HANEL, R., ORTIZ, R. A., LANGER, D., LEVITT, M. R., GRANDHI, R. (2020). MIDDLE MENINGEAL ARTERY EMBOLIZATION TREATMENT OF NONACUTE SUBDURAL HEMATOMAS IN THE ELDERLY: A MULTIINSTITUTIONAL EXPERIENCE OF 151 CASES. NEUROSURGICAL FOCUS, 49 (4). HTTPS://DOI.ORG/10.3171/2020.7.FOCUS20518. SUMMARY: THE INCIDENCE OF ALREADY COMMON CHRONIC SUBDURAL HEMATOMAS (CSDHS) AND OTHER NONACUTE SUBDURAL HEMATOMAS (NASHS) IN THE ELDERLY IS EXPECTED TO RISE AS THE POPULATION AGES OVER THE COMING DECADES. SURGICAL MANAGEMENT IS ASSOCIATED WITH RECURRENCE AND EXPOSES ELDERLY PATIENTS TO PERIOPERATIVE AND OPERATIVE RISKS. MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OFFERS THE POTENTIAL FOR A MINIMALLY INVASIVE, LESS MORBID TREATMENT IN THIS AGE GROUP. THE CLINICAL AND RADIOGRAPHIC OUTCOMES AFTER MMA EMBOLIZATION TREATMENT FOR NASHS HAVE NOT BEEN ADEQUATELY DESCRIBED IN ELDERLY PATIENTS. IN THIS PAPER, THE AUTHORS DESCRIBE THE CLINICAL AND RADIOGRAPHIC OUTCOMES AFTER 151 CASES OF MMA EMBOLIZATION FOR NASHS AMONG 121 ELDERLY PATIENTS IDENTIFIED EVENTS: 1.8 PATIENTS DIED. THREE PATIENT DEATHS (2.5%) OCCURRED WITHIN 24 HOURS OF THE MMA EMBOLIZATION PROCEDURE, WITH ONLY 1 NEUROLOGICAL DEATH DUE TO THE PATIENT DEVELOPING A CEREBELLAR HEMATOMA, REMOTE FROM THE SUBDURAL HEMATOMA. THE REMAINING 5 PATIENT DEATHS (4.1%) OCCURRED BETWEEN 2 AND 6 WEEKS AFTER THE PROCEDURE AND WERE ALL RELATED TO PROGRESSION OF UNDERLYING NEOPLASTIC DISEASE OR WITHDRAWAL OF CARE BY FAMILY. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586447 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Death