BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 22787776 · Received August 12, 2025

    Report

    Report Number
    2029214-2025-01809
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    July 11, 2024
    Report Date
    August 12, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2. REPORTED PATIENT AGE (73 YEARS) IS THE MEDIAN AGE FROM ALL PATIENTS IN THE STUDY GROUP. A3. REPORTED PATIENT SEX (MALE) REPRESENTS THE MAJORITY OF PATIENTS INCLUDED IN THE STUDY (72.9%). B3. REPORTED EVENT DATE (11JUL2024) IS THE EARLIEST PUBLICATION DATE. E1. 14 FACILITIES WERE INCLUDED IN THE INFORMATION REVIEW FOR THE ARTICLE. THE LOCATION INFORMATION PERTAINS TO THE PRIMARY COMMUNICATING AUTHOR. 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

    SALEM, M. M., SIOUTAS, G. S., GAJJAR, A., KHALIFE, J., KUYBU, O., CARROLL, K. T., HOANG, A. N., BAIG, A. A., SALIH, M., BAKER, C., CORTEZ, G. M., ABECASSIS, Z., RUIZ RODRIGUEZ, J. F., DAVIES, J. M., CAWLEY, C. M., RIINA, H., SPIOTTA, A. M., KHALESSI, A., HOWARD, B. M., ¿ BURKHARDT, J. K. (2025). FEMORAL VERSUS RADIAL ACCESS FOR MIDDLE MENINGEAL ARTERY EMBOLIZATION FOR CHRONIC SUBDURAL HEMATOMAS: MULTICENTER PROPENSITY SCORE MATCHED STUDY. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 17(8), 890¿897. HTTPS://DOI.ORG/10.1136/JNIS-2024-021880 REVIEW OF THE LITERATURE ARTICLE FOUND A MULTICENTER REGISTRY REVIEW OF 872 PATIENTS WHO UNDERWENT A TOTAL OF 1070 MIDDLE MENINGEAL ARTERY EMBOLIZATION (MMAE) PROCEDURES FOR THE TREATMENT OF CHRONIC SUBDURAL HEMATOMA (CSDH). THE STUDY COMPARED TRANSRADIAL ACCESS (TRA) WITH THE HISTORICALLY MORE TRADITIONAL TRANSFEMORAL ACCESS (TFA). MULTIPLE MANUFACTURER'S DEVICES WERE USED IN THE TREATMENT PROCEDURES AND IT WAS NOT SPECIFIED WHICH DEVICE WAS USED IN EACH CASE; IT WAS ONLY SPECIFIED THAT ONYX WAS MORE TYPICALLY USED IN TRA PROCEDURE AND PARTICLES WERE MORE TYPICALLY USED IN TFA PROCEDURES. ONYX WAS THE MOST TYPICAL EMBOLIZATION DEVICE, USED IN 433/1070 CASES, ACROSS BOTH TFA AND TRA PROCEDURES. IT WAS NOTED THAT TECHNICAL SUCCESS WAS ACHIEVED IN 97.8% OF CASES (1041/1070). NO DEVICE MALFUNCTION WAS REPORTED. NO PATIENT DEATHS WERE REPORTED. A TOTAL OF 216 PATIENTS HAD MODIFIED RANKIN SCALE SCORE >2 AT THE LAST FOLLOW UP BUT THIS WAS NOT ATTRIBUTED TO THE DEVICE OR THERAPY. THERE WERE A TOTAL OF 39 UNSPECIFIED "COMPLICATIONS" WHICH COULD NOT BE RULED OUT AS POSSIBLY THERAPY RELATED AS IT WAS NOT SPECIFIED IN THE ARTICLE. 3 OF THESE WERE ACCESS SITE HEMATOMAS IN THE TFA GROUP, NONE OF WHICH REQUIRED ADDITIONAL INTERVENTION. 97 CASES REQUIRED ADDITIONAL RESCUE SURGERY WHICH WAS DEFINED AS "CLINICAL FAILURE" DESPITE THE TECHNICAL SUCCESS RATE OF 97.8%. IT WAS NOT CLARIFIED IF ANY OF THESE CASES WERE EXPECTED TO REQUIRE ADDITIONAL EVACUATION SURGERY PRIOR TO EMBOLIZATION OR IF IT WAS DUE TO SOME FAILURE OF EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351023 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention