BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 20391462 · Received October 7, 2024

    Report

    Report Number
    2029214-2024-01804
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    August 13, 2024
    Report Date
    October 7, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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. 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

    L. DEBS, F. VALE, S. WALKER, D. TORO, S. MANSOURI, S. MACOMSON, S. RAHIMI; JOURNAL OF CLINICAL NEUROSCIENCE; 2024; 128: 110783; MIDDLE MENINGEAL ARTERY EMBOLIZATION FOLLOWING SURGICAL EVACUATION OF SYMPTOMATIC CHRONIC SUBDURAL HEMATOMA IMPROVES OUTCOMES, INTERIM RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL; DOI.ORG/10.1016/J.JOCN.2024.110783 LITERATURE WAS REVIEWED REGARDING: NEUROLOGICAL OUTCOMES, RE-INTERVENTIONS, AND THE NEED FOR FOLLOW-UP AND IMAGING STUDIES RELATED TO MMA EMBOLIZATION. THE TIME FRAME OF THIS STUDY WAS: BETWEEN (B)(6) 2022. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX EMBOLIZATION. NO DEATHS OCCURED IN THE STUDY POPULATION. AMONG PATIENT ADVERSE EVENTS RELATED TO ONYX INCLUDE: 5 PATIENTS HAD NO NEUROLOGICAL IMPROVEMENTS OF SYMPTOMATIC CHRONIC SUBDURAL HEMATOMA (CSDH) AT DISCHARGE AND A TOTAL OF 6 HAD NO IMPROVEMENT AT LAST ENCOUNTER. NEUROLOGICAL IMPROVEMENT WAS DEFINED AS AN IMPROVEMENT FROM THE NEUROLOGIC DEFICIT AT PRESENTATION. NEUROLOGIC DEFICITS INCLUDED IMPAIRED ORIENTATION, STRENGTH, SENSATION, BALANCE, AND/OR COORDINATION. ONE PATIENT REQUIRED REPEAT SURGERY DO TO POOR EXAMINATION AND RECURRENCE OF SDH RECEIVED MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION PER REQUEST OF THE PRIMARY SURGEON. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282868 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention