BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 22739820 · Received August 7, 2025

    Report

    Report Number
    2029214-2025-01775
    Event Type
    Injury
    Date Received
    August 7, 2025
    Date of Event
    December 1, 2024
    Report Date
    August 7, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. CITATION: ITSEKSON-HAYOSH, Z., CARPANI, F., MOSIMANN, P. J., AGID, R., HENDRIKS, E. J., RADOVANOVIC, I., BARAZARTE, H. A., SCHAAFSMA, J. D., TERBRUGGE, K., KRINGS, T., MCANDREWS, M. P., <(>&<)> NICHOLSON, P.. DURAL ARTERIOVENOUS FISTULAS: BASELINE COGNITIVE CHANGES AND CHANGES FOLLOWING TREATMENT: A PROSPECTIVE LONGITUDINAL STUDY. AMERICAN JOURNAL OF NEURORADIOL 45(12) 1878-1884 2024. DOI.ORG/10.3174/AJNR.A8449. 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. SEE ATTACHMENTS FOR LITERATURE 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.

    Description of Event or Problem · 0

    ITSEKSON-HAYOSH, Z., CARPANI, F., MOSIMANN, P. J., AGID, R., HENDRIKS, E. J., RADOVANOVIC, I., BARAZARTE, H. A., SCHAAFSMA, J. D., TERBRUGGE, K., KRINGS, T., MCANDREWS, M. P., <(>&<)> NICHOLSON, P.; AMERICAN JOURNAL OF NEURORADIOL; 2024; 45(12) 1878-1884; DURAL ARTERIOVENOUS FISTULAS: BASELINE COGNITIVE CHANGES AND CHANGES FOLLOWING TREATMENT: A PROSPECTIVE LONGITUDINAL STUDY; DOI.ORG/10.3174/AJNR.A8449. LITERATURE WAS REVIEWED REGARDING: "DURAL ARTERIOVENOUS FISTULAS: BASELINE COGNITIVE CHANGES AND CHANGES FOLLOWING TREATMENT: A PROSPECTIVE LONGITUDINAL STUDY." THE TIME FRAME OF THIS STUDY WAS NOT MENTIONED. MULTIPLE MANUFACTURERS¿ DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX EMBOLIZATION. NO DEATHS OCCURRED IN THE STUDY POPULATION. AMONG PATIENT ADVERSE EVENTS INCLUDED: SIGNIFICANT TREATMENT-RELATED COMPLICATIONS, INCLUDING: ONE PATIENT WITH A LARGE ISCHEMIC STROKE REQUIRING REHABILITATION. ONE PATIENT HAD SUBSTANTIAL INTRACEREBRAL HEMORRHAGE REQUIRING REHABILITATION. ONE PATIENT HAD MILD-TO-MODERATE VENOUS INFARCT. COGNITIVE IMPAIRMENT: 20 PATIENTS EXPERIENCED SOME FORM OF DECLINE IN COGNITIVE FUNCTION WHILE OVERALL THE RESULTS INDICATE THAT ENDOVASCULAR TREATMENT OF DAVFS LEADS TO SIGNIFICANT IMPROVEMENT IN COGNITIVE FUNCTION NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505450 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