BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 22708484 · Received August 4, 2025

    Report

    Report Number
    2029214-2025-01752
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    April 3, 2025
    Report Date
    August 4, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: UNK-NV-ONYX (UNKNOWN); CITATION: PATEL, P. D., SALWI, S., SIOUTAS, G., FILO, J., DOHEIM, M. F., DIAMOND, A., SALEM, M. M., MA, L., HOZ, S. S., SULTANY, A., NOGUEIRA, R. G., AL-BAYATI, A. R., LANG, M. J., GOOCH, M. R., TJOUMAKARIS, S.. PARTICLES, LIQUIDS, AND ANTIPLATELETS: RESTARTING ANTIPLATELETS ON POSTINTERVENTION DAY 3 OR LATER IS ASSOCIATED WITH IMPROVED OUTCOMES AFTER PARTICLE EMBOLIZATION. NEUROSURGERY APRIL 2025. DOI:10.1227/NEU.0000000000003440 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING: "PARTICLES, LIQUIDS, AND ANTIPLATELETS: RESTARTING ANTIPLATELETS ON POSTINTERVENTION DAY 3 OR LAT ER IS ASSOCIATED WITH IMPROVED OUTCOMES AFTER PARTICLE EMBOLIZATION." THE OBJECTIVE WAS TO DETERMINE WHETHER THE TIMING OF ANTIPLATELET RESTART AFTER MIDDLE MENINGEAL ARTERY EMBOLIZATION (MMAE) FOR CHRONIC SUBDURAL HEMATOMA (CSDH) AFFECTS LONG-TERM RADIOGRAPHIC AND CLINICAL OUTCOMES. THE TIME FRAME OF THIS STUDY WAS: FROM 2018 TO 2023, USING DATA FROM 4 ACADEMIC MEDICAL CENTERS THAT PERFORMED MMAE FOR CSDH. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. 34 OUT OF 128 PATIENTS WERE TREATED WITH ONYX LIQUID EMBOLIC. AMONG PATIENT ADVERSE EVENTS INCLUDED: 90-DAY MORTALITY: 6 PATIENTS (20.7%) IN THE ONYX GROUP. THE CAUSE FOR MORTALITY WAS NOT COLLECTED IN THIS ANALYSIS NEED FOR SURGICAL RETREATMENT OCCURRED IN 12 TOTAL PATIENTS (9.7%). (PAGE 16) FUNCTIONAL INDEPENDENCE AT 90 DAYS: 19 ONYX PATIENTS (65.5%) WERE FUNCTIONALLY INDEPENDENT (MRS 3) NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660278 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Required Intervention| S SEE H11.