BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKSMAN

    MDR report key: 21649423 · Received March 19, 2025

    Report

    Report Number
    2029214-2025-00717
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 19, 2025
    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

    SEE ATTACHMENTS FOR LITERATURE ARTICLE. 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

    LV, M., DONG, L., WANG, C., WU, X., XU, H., WU, X., ZHANG, Y.; QUANT IMAGING MED SURG; 2025; 15(3):1977-1989; MIDTERM OUTCOMES AND COSTS OF PIPELINE EMBOLIZATION DEVICE ALONE VERSUS ATLAS STENT-ASSISTED COILING FOR UNRUPTURED ANTERIOR CIRCULATION ANEURYSMS: A PROPENSITY SCORE MATCHED COMPARATIVE ANALYSIS; DOI.ORG/10.21037/QIMS-24-1581 LITERATURE WAS REVIEWED REGARDING: MIDTERM OUTCOMES AND COSTS OF PIPELINE EMBOLIZATION DEVICE ALONE VERSUS ATLAS STENT-ASSISTED COILING FOR UNRUPTURED ANTERIOR CIRCULATION ANEURYSMS: A PROPENSITY SCORE MATCHED COMPARATIVE ANALYSIS. THE TIME FRAME OF THIS STUDY WAS: JANUARY 2018 TO JUNE 2023. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE EMBOLIZATION DEVICE PED DELIVERED AND DEPLOYED THROUGH A MARKSMAN MICROCATHETER. 299 PATIENTS WERE TREATED IN THE GROUP SEPARATED FOR PED USE. DEATHS OCCURRED IN THE STUDY POPULATION: ONE DEATH IN THE PED GROUP DUE TO RUPTURE OF THE TARGET ANEURYSM. AMONG PATIENT ADVERSE EVENTS INCLUDED: IN-STENT STENOSIS (ISS), HIGHER IN THE PED GROUP (4.2%). ONE PATIENT REQUIRED RETREATMENT. IN PED GROUP: 15 (5.0%) PATIENTS WITH COM PLICATIONS: 7 ISCHEMIC (4 TRANSIENT ISCHEMIC ATTACK (TIA), 3 CEREBRAL INFARCTION), 6 HEMORRHAGIC (4 DELAYED ANEURYSM RUPTURE, 2 DISTAL INTRAPARENCHYMAL HEMORRHAGE), 2 EMERGING COMPRESSION SYMPTOMS REFERING TO CRANIAL NEUROPATHY OR BRAINSTEM SYMPTOMS ASSOCIATED WITH ANEURYSM COMPRESSION. EIGHT (2.6%) PATIENTS WERE TREATED WITH OVERLAPPED PED DEVICES. 2 PATIENTS IN THE PED GROUP DISCHARGED WITH POOR NEUROLOGICAL STATUS. FOUR (1.3%) CASES REQUIRED STENT ADJUSTMENT. PATIENTS OF PED GROUP WERE RETREATED IF (I) THE PED MAY FAIL TO FULLY COVER THE ANEURYSM NECK, OR THE DISTAL END OF THE PED MAY FALL INTO THE ANEURYSMAL SAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450275 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-MARKSMAN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention