BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARATHON

    MDR report key: 19660111 · Received July 2, 2024

    Report

    Report Number
    2029214-2024-01167
    Event Type
    Death
    Date Received
    July 2, 2024
    Date of Event
    November 27, 2023
    Report Date
    July 2, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 'FATAL INTRACEREBRAL HEMORRHAGE FOLLOWING ENDOVASCULAR ONYX EMBOLIZATION OF AN ARTERIOVENOUS MALFORMATION: A CASE REPORT'. THE STUDY TIME FRAME WAS NOT EXPLICITLY MENTIONED IN THE PROVIDED CONTEXT INFORMATION. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: MARATHON MICROCATHETER, ONYX EMBOLIZATION A ND MIRAGE MICRO GUIDEWIRE'. A DEATH OCCURRED IN THE STUDY. THE CAUSE OF DEATH WAS 'INTRAVENTRICULAR HEMORRHAGE IN ALL VENTRICLES AND LEFT THALAMIC INTRACEREBRAL HEMORRHAGE AFTER THE PROCEDURE, LEADING TO THE PATIENT'S DEATH ON THE 14TH DAY AFTER EMBOLIZATION'. AMONG PATIENT ADVERSE EVENTS INCLUDED: 'DEVELOPMENT OF ALTERED MENTAL STATUS AND RIGHT HEMIPARESIS AFTER THE EMBOLIZATION PROCEDURE, INTRAVENTRICULAR HEMORRHAGE IN ALL VENTRICLES, LEFT THALAMIC INTRACEREBRAL HEMORRHAGE, DETERIORATING MENTAL STATUS, ADDITIONAL MULTIFOCAL INTRACEREBRAL HEMORRHAGE, AND EVENTUAL DEATH'. AT THE END OF THE PROCEDURE, THE PATIENT¿S BLOOD PRESSURE SUDDENLY INCREASED TO 180 MM HG; THEREFORE, THE PROCEDURE WAS STOPPED AND CT WAS PERFORMED IMMEDIATELY. HEAD CT REVEALED INTERVENTRICULAR HEMORRHAGE IN ALL VENTRICLES, WITH INTRACEREBRAL HEMORRHAGE IN THE LEFT THALAMUS. DESPITE EMERGENT EXTERNAL VENTRICULAR DRAINAGE AND AGGRESSIVE TREATMENT TO LOWER THE INTRACRANIAL PRESSURE, THE PATIENT¿S MENTAL STATUS DETERIORATED. SUBSEQUENTLY, AN ADDITIONAL MULTIFOCAL INTRACEREBRAL HEMORRHAGE OCCURRED, AND THE PATIENT EVENTUALLY DIED ON THE 14TH DAY AFTER THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800958 MARATHON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-MARATHON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown Death