BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 22794753 · Received August 13, 2025

    Report

    Report Number
    2029214-2025-01815
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    February 1, 2025
    Report Date
    August 13, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. CITATION: SANTIAGO, R. B., DENGRI, C., KAYE, B., SABAHI, M., SANTOS, R. C., SARNA, K., GWIEZDZINSKI, S., ADADA, B., BORGHEI-RAZAVI, H., REYES, D., <(>&<)> OBRZUT, M. NATURAL HISTORY OF CHRONIC SUBDURAL HEMATOMA FOLLOWING MIDDLE MENINGEAL ARTERY EMBOLIZATION: A RETROSPECTIVE ANALYSIS. WORLD NEUROSURGERY 194: 123501 2025. DOI.ORG/10.1016/J.WNEU.2024.11.084 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. SEE ATTACHMENTS FOR LITERATURE ARTICLE. A3: AGE AND A3B ARE AVERAGE OF COHORT. 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

    SANTIAGO, R. B., DENGRI, C., KAYE, B., SABAHI, M., SANTOS, R. C., SARNA, K., GWIEZDZINSKI, S., ADADA, B., BORGHEI-RAZAVI, H., REYES, D., <(>&<)> OBRZUT, M; WORLD NEUROSURGERY; 2025; 194: 123501; NATURAL HISTORY OF CHRONIC SUBDURAL HEMATOMA FOLLOWING MIDDLE MENINGEAL ARTERY EMBOLIZATION: A RETROSPECTIVE ANALYSIS; DOI.ORG/10.1016/J.WNEU.2024.11.084 LITERATURE WAS REVIEWED REGARDING THE EFFICACY OF MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION IN THE MANAGEMENT OF CHRONIC SUBDURAL HEMATOMA (CSDH). RECENT RANDOMIZED CONTROLLED TRIALS SUPPORT ITS USE, BUT LONG-TERM DATA ON THE NATURAL HISTORY OF CSDH POST-TREATMENT REMAIN LIMITED. THE TIME FRAME OF THIS STUDY WAS OCTOBER 2019 TO DECEMBER 2022. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX-18 EMBOLIC. ONE DEATH OCCURRED IN THE STUDY POPULATION. THE CAUSES OF DEATH WERE LIVER FAILURE RELATED TO END-STAGE HEPATOCELLULAR CARCINOMA AND NOT RELATED TO DEVICE OR PROCEDURE. AMONG PATIENT ADVERSE EVENTS INCLUDED: ONE PATIENT (2%) WITH SEVERE ATHEROSCLEROSIS EXPERIENCED HYPOPERFUSION IN THE RIGHT LOWER EXTREMITY FOLLOWING FEMORAL ACCESS, WHICH REQUIRED CORRECTION BY VASCULAR SURGERY. FOUR PATIENTS FROM HAD A RECURRENCE AND NEEDED SURGICAL RESCUE (8.2%), NO SPECIFIC FACTORS CONTRIBUTING TO TREATMENT FAILURE WERE IDENTIFIED WITHIN THIS GROUP. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563392 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7100-060 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Required Intervention