BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIUM

    MDR report key: 20879338 · Received December 9, 2024

    Report

    Report Number
    2029214-2024-02259
    Event Type
    Death
    Date Received
    December 9, 2024
    Date of Event
    January 21, 2024
    Report Date
    December 9, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: DUAN, G., ZHANG, Y., LI, Q., YANG, P., ZHANG, J., WANG, H., MA, J., GUAN, S., HAN, Z., YANG, H., SHI, H., LIU, Y., LIANG, C., WU, X., WU, Y., ZUO, Q., FENG, Z., ZHANG, L., LI, Z., ZHOU, Y., DAI, D., F. GEKKO COIL SYSTEM: SAFETY AND EFFICACY IN TREATING INTRACRANIAL ANEURYSMS. WORLD NEUROSURG 185:181-189 2024. 10.1016/J.WNEU.2024.01. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    THE LITERATURE WAS REVIEWED REGARDING THE STUDY AIMED TO EVALUATE THE SAFETY AND EFFICACY OF THE GEKKO COIL SYSTEM IN TREATING INTRACRANIAL ANEURYSMS (IAS) IN CLINICAL PRACTICE. THE STUDY WAS CONDUCTED BETWEEN MAY 2018 AND SEPTEMBER 2020. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE MEDTRONIC DEVICE USED IN THE STUDY WAS THE AXIUM COIL SYSTEM. DEATHS OCCURRED IN THE STUDY POPULATION. SPECIFICALLY, 3 PATIENTS IN THE TEST GROUP (GEKKO COIL) DIED, RESULTING IN A MORTALITY RATE OF 2.33%, AND 2 PATIENTS IN THE CONTROL GROUP (AXIUM COIL) DIED, RESULTING IN A MORTALITY RATE OF 1.57%. HOWEVER, THE SPECIFIC CAUSES OF DEATH WERE NOT DETAILED. AMONG PATIENT ADVERSE EVENTS INCLUDED SYMPTOMATIC CEREBRAL INFARCTION OR THROMBOSIS: 5 CASES IN THE GEKKO GROUP AND 6 CASES IN THE AXIUM GROUP; SYMPTOMATIC INTRACRANIAL HEMORRHAGE: 1 CASE IN THE GEKKO GROUP AND 2 CASES IN THE AXIUM GROUP; OTHER COMPLICATIONS SUCH AS HYDROCEPHALUS: 4 CASES IN THE GEKKO GROUP AND 3 CASES IN THE AXIUM GROUP. ADDITIONALLY, THE INCIDENCE OF ADVERSE EVENTS WAS 48.06% IN THE GEKKO GROUP AND 51.97% IN THE AXIUM GROUP, WITH THE INCIDENCE OF SERIOUS ADVERSE EVENTS (SAES) BEING 12.40% IN THE GEKKO GROUP AND 16.54% IN THE AXIUM GROUP. NO TARGET ANEURYSMAL BLEEDING OCCURRED IN EITHER GROUP DURING THE 12-MONTH POSTOPERATIVE FOLLOW-UP PERIOD. THE GEKKO COIL SYSTEM WAS FOUND TO BE NONINFERIOR TO THE AXIUM COIL SYSTEM IN TERMS OF EFFICACY AND SAFETY FOR IA EMBOLIZATION, WITH THE SUCCESSFUL ANEURYSM OCCLUSION RATE AT 6 MONTHS BEING 96.08% FOR THE GEKKO COIL GROUP COMPARED WITH 96.12% IN THE AXIUM COIL GROUP. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107373 AXIUM DEVICE, NEUROVASCULAR EMBOLIZATION HCG MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-AXIUM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Death