BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARKSMAN

    MDR report key: 22910014 · Received August 27, 2025

    Report

    Report Number
    2029214-2025-01914
    Event Type
    Death
    Date Received
    August 27, 2025
    Date of Event
    April 22, 2025
    Report Date
    August 27, 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

    CITATION: WANG, C., ZHOU, Y., ZHANG, Y., WEI, D., TURHON, M., LIU, J., ZHANG, Y., WANG, K., ZHANG, H., LI, T., MAIMAITILI, A., MAO, G., SONG, D., WANG, Y., FENG, W., WANG, Y., SHI, H., WAN, J., LIU, J. DELAYED ISCHEMIC STROKE AFTER PED PLACEMENT FOR ANEURYSMS: OPTIMAL DURATION OF DUAL ANTIPLATELET THERAPY AND RISK FACTORS. FRONTIERS IN NEUROLOGY 16, 1561965 2025. DOI.ORG/10.3389/FNEUR.2025.1561965 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. A2 AGE AND A3A SEX ARE AVERAGE OF COHORT. 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

    WANG, C., ZHOU, Y., ZHANG, Y., WEI, D., TURHON, M., LIU, J., ZHANG, Y., WANG, K., ZHANG, H., LI, T., MAIMAITILI, A., MAO, G., SONG, D., WANG, Y., FENG, W., WANG, Y., SHI, H., WAN, J., LIU, J; FRONTIERS IN NEUROLOGY; 2025; 16, 1561965; DELAYED ISCHEMIC STROKE AFTER PED PLACEMENT FOR ANEURYSMS: OPTIMAL DURATION OF DUAL ANTIPLATELET THERAPY AND RISK FACTORS; DOI.ORG/10.3389/FNEUR.2025.1561965 LITERATURE WAS REVIEWED REGARDING A STUDY AIMING TO INVESTIGATE THE INCIDENCE AND POTENTIAL RISK FACTORS OF DIS IN A LARGE COHORT OF PATIENTS IN CHINA TREATED WITH PED FOR INTRACRANIAL ANEURYSMS. ADDITIONALLY, THE STUDY EXPLORES THE ASSOCIATION BETWEEN THE DURATION OF DUAL ANTIPLATELET THERAPY (DAPT) AND THE OCCURRENCE OF DELAYED ISCHEMIC STROKE (DIS). THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE EMBOLIZATION DEVICE (EITHER CLASSIC OR FLEX), MARKSMAN CATHETER, AND PHENOM 27 CATHETER. THE TIMEFRAME OF THE STUDY WAS BETWEEN NOVEMBER 2014 AND OCTOBER 2019. 15 DEATHS OCCURRED IN THE STUDY POPULATION WITHIN ON MONTH; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RE LATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. THE CAUSES OF DEATH WERE NOT REPORTED AMONG ALL MEDTRONIC DEVICES PATIENTS¿ ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: 12 PATIENTS EXPERIENCED DELAYED ISCHEMIC STROKE (DIS). OF WHICH FIVE PATIENTS SUFFERED TRANSIENT ISCHEMIC ATTACKS, AND SEVEN EXPERIENCED INFARCTIONS. IMAGING REVEALED THAT THE EMBOLIZED AREA CORRESPONDED TO THE LOCATION WHERE THE PED HAD BEEN DEPLOYED, WITH NO ADDITIONAL INFARCTS DETECTED. TWO PATIENTS EXPERIENCED STROKES DUE TO STENOSIS OR OCCLUSION OF THE PARENT ARTERY COVERED BY THE PED. ONE PATIENT UNDERWENT ASPIRATION THROMBECTOMY AND BYPASS SURGERY. THE OTHER PATIENTS RECEIVED MEDICAL TREATMENT AND REHABILITATION, WITH ONLY ONE PATIENT EXHIBITING POOR NEUROLOGICAL FUNCTION (MODIFIED RANKIN SCALE SCORE = 3) AT THE LAST FOLLOW-UP. ONE PATIENT EXPERIENCED SUDDEN HEADACHES ACCOMPANIED BY PROJECTILE VOMITING, FACIAL ASYMMETRY, AND RIGHT-SIDED HEMIPLEGIA, WITH RIGHT CEREBRAL INFARCTION BY CT 10 MONTHS AFTER PROCEDURE. NO MAJOR BLEEDING EVENTS, INCLUDING INTRACRANIAL OR VISCERAL HEMORRHAGES, WERE OBSERVED DURING THE FOLLOW-UP PERIOD. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520022 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-MARKSMAN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Death