BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 20424951 · Received October 10, 2024

    Report

    Report Number
    2029214-2024-01846
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    November 29, 2013
    Report Date
    October 10, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    R. KONDO, Y. MATSUMOTO, H. ENDO, S. MIYACHI, M. EZURA, AND N. SAKAI; NEUROL MED CHIR; 2014; 54, 54¿62; ENDOVASCULAR EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS: RESULTS OF THE JAPANESE REGISTRY OF NEUROENDOVASCULAR THERAPY (JR-NET) 1 AND 2; DOI: 10.217 6/NMC.OA2013-0183. LITERATURE WAS REVIEWED REGARDING 'ENDOVASCULAR EMBOLIZATION OF CEREBRAL AVMS', SHOWING A HIGH DEGREE OF SAFETY AND A LOW RATE OF SYMPTOMATIC COMPLICATIONS IN THE JAPANESE POPULATION. THE TIME FRAME OF THIS STUDY WAS 'BETWEEN JANUARY 2005 AND DECEMBER 2006 FOR JR-NET 1 AND BETWEEN JANUARY 2007 AND DECEMBER 2009 FOR JR-NET 2'. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX EMBOLIZATION WAS USED IN 54 PATIENTS (5.5% OF TREATMENTS). THREE DEATHS OCCURRED IN THE STUDY POPULATION. THE CAUSES OF DEATH WERE NOT PROVIDED. AMONG PATIENT ADVERSE EVENTS INCLUDED: INTRACRANIAL HEMORRHAGES, CEREBRAL ISCHEMIA, ARTERIAL DISSECTIONS, CATHETER GLUING, AND OTHER COMPLICATIONS.  SUCCESSFUL MRS SCORES WERE ACHIEVED IN 80.0% OF PATIENTS. COMPLICATION:  ANY TECHNICAL COMPLICATION 91 (9.2%).  SYMPTOMATIC COMPLICATION 25 (2.5%).  DISABLING COMPLICATION 15 (1.5%). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345679 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male