BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 22792737 · Received August 13, 2025

    Report

    Report Number
    2029214-2025-01812
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    August 8, 2024
    Report Date
    September 5, 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

    CITATION: MA, L., HOZ, S.S., DOHEIM, M., FADHIL, A., SULTANY, A., AL-BAYATI, A.R., NOGUEIRA, R., LANG, M., GROSS, B.A,. MIDDLE MENINGEAL ARTERY EMBOLIZATION FOR ¿TRIAL-INELIGIBLE¿ CHRONIC SUBDURAL HEMATOMAS. NEUROSURGERY 96 2025. DOI: 10.1227/NEU.0000000000003136 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. NOTE THAT THE PATIENT INFORMATION (AGE, SEX) IS REFLECTIVE OF THE MEAN OF THE PATIENT DATA IN THE ARTICLE. 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.

    Additional Manufacturer Narrative · 0

    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 MIDDLE MENINGEAL ARTERY EMBOLIZATION FOR ¿TRIAL-INELIGIBLE¿ CHRONIC SUBDURAL HEMATOMAS. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX LIQUID EMBOLIC AMONG ALL PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: NEUROLOGICALLY MORE DISABLING CHRONIC SUBDURAL HEMATOMA (CSDHS) (MRS 2 OR ABOVE) EXHIBITED A NUMERICALLY HIGHER RATE OF SURGICAL RESCUE (18%). ONE PATIENT EXPERIENCED ACCESS SITE HEMATOMA. THERE WAS ONE COMPLICATION REQUIRING INTERVENTION. SEVEN PATIENTS EXPERIENCED DETERIORATION OF NEUROLOGICAL FUNCTION. 2 EXPERIENCED CONSCIOUSNESS CHANGE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ADVERSE EVENTS RELATED TO ANY MEDTRONIC PRODUCTS OR DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76622 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention