BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 22560622 · Received July 21, 2025

    Report

    Report Number
    2029214-2025-01654
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    January 1, 2024
    Report Date
    July 21, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. CONTINUATION OF D10: PRODUCT ID UNK-NV-ONYX (LOT: UNKNOWN); PRODUCT TYPE: IMPLANT DATE N/A; EXPLANT DATE N/A CITATION: FANA, M., SANTANGELO, G., ALBANNA, A., JUM'AH, A., REHMAN, M. OPTIMAL TIMELINE AND HEMATOMA SIZE PARAMETERS FOR MIDDLE MENINGEAL ARTERY EMBOLIZATION IN ACUTE-ON-CHRONIC SUBDURAL HEMATOMAS. THE NEUROHOSPITALIST 15(2):91-99 2024. DOI:10.1177/19418744241285275 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 'MMA EMBOLIZATION IN ACUTE-ON-CHRONIC SUBDURAL HEMATOMAS'. THE TIME FRAME OF THIS STUDY WAS JANUARY 2016 TO JANUARY 2023. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX LIQUID EMBOLIC DEATHS OCCURRED IN THE STUDY POPULATION. IT WAS NOTED THAT THERE WERE 2 PATIENT DEATHS, BUT BOTH WERE SAID TO BE UNRELATED. AMONG ADVERSE EVENTS FOR PATIENTS TREATED WITH ONYX INCLUDED: FOLLOW-UP CT HEAD ACUTE HEMATOMA BLEED (2 PATIENTS). ONE CASE WAS SAID TO BE MINOR LEFT PARIETAL AT 4 WEEKS. IT WAS NOTED THAT THE OTHER PATIENT UNDERWENT SURGICAL INTERVENTION OF BURR HOLES WITH RIGHT CRANIOTOMY AND SUBDURAL DRAINS AT 4 WEEKS POST-EMBOLIZATION. MILD HEMODYNAMIC INSTABILITY INTRA-OPERATIVELY (1 PATIENT) MILD HEADACHES (1 PATIENT) NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738028 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R SEE H11...