BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 22479431 · Received July 11, 2025

    Report

    Report Number
    2029214-2025-01567
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    October 28, 2016
    Report Date
    July 11, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: IKEDA, H., IMAMURA, H., AGAWA, Y., IMAI, Y., TANI, S., ADACHI, H., ISHIKAWA, T., MINEHARU, Y., SAKAI, N.. ONYX EXTRAVASATION DURING EMBOLIZATION OF A BRAIN ARTERIOVENOUS MALFORMATION. INTERVENTIONAL NEURORADIOLOGY 23(2):200-205 2017. DOI:10.1177/1591019916680112 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING: A CASE OF ONYX EXTRAVASATION DURING EMBOLIZATION OF A CEREBELLAR ARTERIOVENOUS MALFORMATION (AVM), CONFIRMED BY SURGICAL RESECTION AND PATHOLOGICAL ANALYSIS. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX (EV3 COVIDIEN) AS THE LIQUID EMBOLIC AGENT. NO DEATHS OCCURRED IN THE STUDY POPULATION. AMONG PATIENT ADVERSE EVENTS INCLUDED: ONYX EXTRAVASATION OCCURRED DURING THE EMBOLIZATION PROCEDURE. AN OBLATE ONYX CAST WAS REMOVED DURING TOTAL RESECTION OF THE AVM, PERFORMED THE SAME DAY. THE PATIENT SHOWED SATISFACTORY PROGRESS WITHOUT NEUROLOGICAL ABNORMALITIES. THE PATIENT WAS FOLLOWED FOR FOUR YEARS POSTOPERATIVELY, AND ADVERSE EVENTS CAUSED BY ONYX EXTRAVASATION HAD NOT BEEN OBSERVED. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073068 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