BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 21647135 · Received March 19, 2025

    Report

    Report Number
    1723170-2025-01384
    Event Type
    Death
    Date Received
    March 19, 2025
    Date of Event
    November 18, 2024
    Report Date
    March 19, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E0117: HYDROCEPHALUS E0118: INTRACRANIAL HEMORRHAGE E0306: SEPSIS E0742: HYPOXIC RESPIRATORY FAILURE E1901: PNEUMONIA E2401: MULTIORGAN FAILURE, DEATH E0506: INTRAVENTRICULAR EXTENSION E0602: CARDIAC ARREST H3, H6: NO PRODUCTS WERE RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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

    CITATION: TEKLE W, BENITES G, MILLER S, ET AL, J NEUROLNTERVENT SURG EPUB DOI:10.1136LJNIS-2024-022237 SUMMARY: BACKGROUND THERE IS GROWING INTEREST AND EVIDENCE IN SPONTANEOUS INTRACEREBRAL HEMORRHAGE (ICH) EVACUATION WITH MINIMALLY INVASIVE S URGERY (MIS). IF EARLY ICH EVACUATION BECOMES THE STANDARD OF CARE, TRAINING NEUROINTERVENTIONALISTS TO PERFORM MIS WOULD EXPAND GLOBAL ACCESS TOTREATMENT. WE PRESENT A RETROSPECTIVE ANALYSIS OF PATIENTS WHO UNDERWENT MIS-ICH EVACUATION PERFORMED BY INTERVENTIONAL NEUROLOGISTS IN COLLABORATION WITH NEUROSURGEONS. METHOD PATIENTS MEETING PRESPECIFIED CRITERIA UNDERWENT MIS-ICH EVACUATION USING THE ARTEMIS (PENUMBRA) BY AN INTERVENTIONAL NEUROLO GISTNEUROSURGEON TEAM. BASELINE DEMOGRAPHIC, CLINICAL, AND RADIOGRAPHIC CHARACTERISTICS WERECOLLECTED. PROCEDURE LOCATION WAS RECORDED. THE PRIMARY OUTCOME OF INTEREST WAS THE RATE OF SYMPTOMATIC REBLEEDING. SECONDARY OUTCOMES INCLUDED HEMATOMA REDUCTION, SERIOUS ADVERSE EVENTS, LENGTH OF STAY, DISPOSITION, AND DISCHARGE AND 6 MONTH FUNCTIONAL STATUS. RESULTS 19 PATIENTS WERE INCLUDED IN THIS ANALYSIS. ONE THIRD OF CASES WERE PERFORMED IN THE NEUROANGIOGRAPHY SUITE USING INTRAPROCEDURAL FLAT PANEL CT AND THE REST WERE PERFORMED IN THE OPERATING ROOM. ALL WERE PERFORMED UNDER NEURONAVIGATION USING AXIEM (MEDTRONIC-STEALTH-STATION). THERE WAS A MEDIAN 80% HEMATOMA REDUCTION FROM A MEDIAN PREOPERATIVE ICH VOLUME OF 31.1 ML (IQR 26.2-56.4). A POST-PROCEDURAL HEMATOMA VOLUME OF 15 ML WAS ACHIEVED IN 67% OF CASES, COMPARABLE WITH THAT SEEN IN THE ENRICH (EARLY MINIMALLY INVASIVE REMOVAL OF LNTRACEREBRAL HEMORRHAGE) TRIAL (72.7%). NO PATIENTS DEVELOPED SYMPTOMATIC POSTPROCEDURAL HEMATOMA EXPANSION. CONCLUSION THIS STUDY SUGGESTS THAT MIS-ICH EVACUATION CAN BE PERFORMED SAFELY AND EFFECTIVELY BY TRAINED NEUROINTERVENTIONALISTS. OUR EXPERIENCE ALSO SUPPORTS THE ABILITY TO PERFORM MIS-ICH EVACUATION IN THE NEUROANGIOGRAPHY SUITE. WE ADVOCATE FOR THE DEVELOPMENT OF A STANDARDIZED NEUROINTERVENTIONAL TRAINING PROTOCOL AND CERTIFICATION PATHWAY FOR THE PERFORMANCE OF MIS-ICH EVACUATION WITH THE GOAL OF IMPROVING GLOBAL ACCESS TO CARE. REPORTED EVENT(S): THIS ARTICLE DOCUMENTED THE CASES OF 19 PATIENTS. THE MEDIAN AGE OF THE PATIENTS WAS 62 YEARS, AND 47% WERE WOMEN. THREE PATIENTS DIED WITHIN 7 DAYS. ONE PATIENT UNDERWENT CRANIECTOMY >72 HOURS POST-MIS FOR SYMPTOMATIC CEREBRAL EDEMA IMMEDIATELY AFTER WHICH HE DEVELOPED MASSIVE ICH WITH INTRAVENTRICULAR EXTENSION, HYDROCEPHALUS, AND MIDLINE SHIFT, AND PROGRESSED TO BRAIN DEATH. THE SECOND PATIENT DIED FROM MULTIORGAN FAILURE IN THE SETTING OF SEPSIS. THE THIRD PATIENT DIED LATER DURING HOSPITALIZATION FROM CARDIAC ARREST IN THE SETTING OF HYPOXIC RESPIRATORY FAILURE DUE TO COVID-19 PNEUMONIA. NO OTHER SERIOUS ADVERSE EVENTS WERE RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640733 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death| R| H