BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKSMAN

    MDR report key: 20418803 · Received October 10, 2024

    Report

    Report Number
    2029214-2024-01833
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    December 1, 2018
    Report Date
    October 10, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. G2: CITATION: AUTHORS: LIANG, W., YIN, J., LU, C., YANG, J., MA, X., ZHANG, X., TURHON, M., <(>&<)> YANG, X.. TREATMENT OF INTRACRANIAL ANEURYSMS WITH PIPELINE EMBOLIZATION DEVICE: A SINGLE-CENTER EXPERIENCE. QUANTITATIVE IMAGING IN MEDICINE AND SURGERY 14(4), 2916-2926 2024. HTTPS://DX.DOI.ORG/10.21037/QIMS-23-1289. 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 THE TREATMENT OF INTRACRANIAL ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE, BASED ON A SINGLE-C ENTER EXPERIENCE. THE TIME FRAME OF THIS STUDY WAS FROM DECEMBER 2018 TO JANUARY 2022. MULTIPLE MANUFACTURERS¿ DEVICES WERE USED IN THE STUDY POPULATION. AMONG THE MEDTRONIC DEVICES, THE MARKSMAN MICROCATHETER WAS UTILIZED. THERE WERE NO REPORTED MORTALITIES IN THE STUDY POPULATION. HOWEVER, VARIOUS ADVERSE EVENTS WERE DOCUMENTED, INCLUDING ISCHEMIC COMPLICATIONS, DETERIORATION IN THE MODIFIED RANKIN SCALE (MRS), IN-STENT STENOSIS, ISCHEMIC STROKE, AND NEW POSTOPERATIVE NEUROLOGICAL DEFICITS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1924687 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-MARKSMAN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other