BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 22817119 · Received August 15, 2025

    Report

    Report Number
    2029214-2025-01830
    Event Type
    Death
    Date Received
    August 15, 2025
    Date of Event
    March 26, 2025
    Report Date
    August 15, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE IS INCLUDED IN THE ATTACHMENTS. A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF ONLINE PUBLICATION OF THE ARTICLE. G4: PMA CODE MISSING AS DEVICE MODEL AND LOT NUMBERS ARE UNKNOWN. 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

    ISIDOR, J., ABO KASEM, R., SOWLAT, M.-M., CUNNINGHAM, C., LEVITT, M., MCGRATH, M., OGILVY, C. S., ALWAKAA, O., PAUL, A. R., CULLEN, M., ABECASSIS, I. J., ALHOURANI, A., FRAGATA, I., BAPTISTA, M., ALARAJ, A., TSHIBANGU, M., SIDDIQUI, F., LARSON, E., PSYCHOGIOS, M.-N., ¿ STRICKLAND, B. A. (2025). COMPARISON OF EMBOLIC AGENTS IN PREOPERATIVE EMBOLIZATION FOR INTRACRANIAL MENINGIOMAS: MULTICENTER ADJUSTED ANALYSIS OF 275 CASES. JOURNAL OF NEUROINTERVENTIONAL SURGERY. HTTPS://DOI.ORG/10.1136/JNIS-2025-023062 LITERATURE WAS REVIEWED REGARDING A STUDY THAT COMPARED THREE TYPES OF EMBOLIC MATERIALS¿PARTICLES, LIQUID AGENTS, AND COILS¿USED IN PREOPERATIVE EMBOLIZATION FOR MENINGIOMAS INVOLVING 275 PATIENTS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. TWO DEATHS OCCURRED IN PATIENTS WHERE ONYX WAS USED, BUT THE CAUSE OF THEIR DEATHS WERE NOT SPECIFIED. AMONG ALL ONYX PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: HEMORRHAGE/EDEMA ASSOCIATED WITH EMBOLIZATION, BLOOD TRANSFUSION, POST-EMBOLIZATION STROKE, EDEMA CAUSING MASS EFFECT, CRANIAL NERVE PALSY, POSTOPERATIVE INFECTION, RETREATMENT/RESCUE SURGERY, MORTALITY. IN THE STUDY COHORT, ONYX REPRESENTED 96.6% OF THE LIQUID EMBOLIC AGENTS USED FOR PREOPERATIVE MENINGIOMA EMBOLIZATION. PATIENTS IN THE ONYX GROUP SHOWED A HIGHER PERCENTAGE OF GROSS TOTAL RESECTION, A LOWER RETREATMENT RATE, AND A STATISTICALLY INSIGNIFICANT HIGHER COMPLICATION RATE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788386 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Death