BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 20440011 · Received October 14, 2024

    Report

    Report Number
    2029214-2024-01863
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    June 11, 2024
    Report Date
    October 14, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: MA, L., HOZ, S. S., DOHEIM, M. F., FADHIL, A., SULTANY, A., AL-BAYATI, A. R., NOGUEIRA, R. G.,LANG, M. J., GROSS, B. A.. IMPACT OF EMBOLISATE PENETRATION, TYPE, AND TECHNIQUE ON RESULTS AFTER STANDALONE MIDDLE MENINGEAL ARTERY EMBOLIZATION FOR CHRONIC SUBDURAL HEMATOMA. NEUROSURGERY 00:1¿12 2024. DOI: 10.1227/NEU.0000000000 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: IMPACT OF EMBOLISATE PENETRATION, TYPE, AND TECHNIQUE ON RESULTS AFTER STANDALONE MIDDLE MENINGEAL ARTERY EMBOLIZATION FOR CHRONIC SUBDURAL HEMATOMA THE TIME FRAME OF THIS STUDY WAS: FROM 2019 THROUGH 2022 MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX LIQUID EMBOLISATE DEATHS OCCURRED IN THE STUDY POPULATION. 12 DEATHS OF UNRELATED CAUSES WITHIN 6 WEEKS OF EMBOLIZATION AMONG PATIENT ADVERSE EVENTS INCLUDED: PROCEDURAL-RELATED COMPLICATIONS: ACCESS SITE HEMATOMA/GROIN: 2 CATHETER ENTRAPMENT: 1 SURGICAL RESCUE WAS REQUIRED IN 9 CASES (7.7%) DUE TO SYMPTOMATIC CSDH PROGRESSION AT A MEDIAN TIME OF 20 DAYS AFTER EMBOLIZATION NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222276 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention