BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 20534326 · Received October 25, 2024

    Report

    Report Number
    2029214-2024-01992
    Event Type
    Death
    Date Received
    October 25, 2024
    Date of Event
    January 24, 2024
    Report Date
    October 25, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: GOUTNIK, M., NGUYEN, A., FLEETING, C., PATEL, A., LUCKE-WOLD, B., LAURENT, D., WAHBEH, T., AMINI, S., AL SAIEGH, F., KOCH, M., HOH, B., <(>&<)> CHALOUHI, N.. ASSESSMENT OF BLOOD LOSS DURING NEUROENDOVASCULAR PROCEDURES. JOURNAL OF CLINICAL MEDICINE 13(3), 677 2024. DOI:10.3390/JCM13030677 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE SEX OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. 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

    LITERATURE WAS REVIEWED REGARDING "ASSESSMENT OF BLOOD LOSS DURING NEUROENDOVASCULAR PROCEDURES". THE TIME FRAME OF THIS STUDY WAS FROM JANUARY 2020 TO OCTOBER 2020. A RETROSPECTIVE REVIEW OF 200 CONSECUTIVE ENDOVASCULAR PROCEDURES WAS PERFORMED. THE MEAN AGE OF OUR COHORT WAS 60.1 YEARS AND THE MALE REPRESENTATION WAS 52.5%. OF THE PATIENTS, 62 (31.0%) HAD DIAGNOSTIC ANGIOGRAMS WITHOUT INTERVENTION, WHILE 138 (69.0%) HAD ENDOVASCULAR INTERVENTIONS INCLUDING COIL EMBOLIZATION, ONYX EMBOLIZATION, FLOW DIVERSION, OR THROMBECTOMY.  THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX DEATHS OCCURRED IN THE STUDY POPULATION. -1 PATIENT PASSED AWAY DURING HOSPITALIZATION. NO SPECIFIC CAUSE OF DEATH WAS MENTIONED. AMONG PATIENT ADVERSE EVENTS INCLUDED: -THE MEAN HEMOGLOBIN DECREASE WAS 1.0 G/DL, WHILE THE MEAN HEMATOCRIT DECREASE WAS 2.8% FOR ALL PROCEDURES COMBINED. THE MEAN HEMOGLOBIN DECREASE WAS 0.5 G/DL FOR DIAGNOSTIC ANGIOGRAMS COMPARED TO 1.2 G/DL FOR ENDOVASCULAR INTERVENTIONS. FOR ENDOVASCULAR INTERVENTIONS, 56 (40.6%) HAD HEMOGLOBIN DECREASE OF <(><<)>1, 59 (42.8%) 1-2 AND 23 (16.6%) >2. -1 PATIENT HAD A GROIN HEMATOMA -3 PATIENTS HAD INTRACRANIAL HEMORRHAGE (ICH) NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812197 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Death SEE H11...