BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKSMAN

    MDR report key: 21178562 · Received January 17, 2025

    Report

    Report Number
    2029214-2025-00155
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 28, 2024
    Report Date
    February 11, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: PED2-475-16 (B772108). 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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

    IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE USING A PIPELINE EMBOLIZATION DEVICE, SEVERAL ISSUES WERE ENCOUNTERED. INITIALLY, THE DEVICE COULD NOT BE DELIVERED BECAUSE THE PROTECTIVE SHEATH WAS IN A CLOSED STATE. THIS WAS RESOLVED BY CUTTING OPEN THE SHEATH WITH SURGICAL SCISSORS. DURING THE IMPLANTATION PROCESS, THE STENT'S POSITION REQUIRED ADJUSTMENT, AND AN ATTEMPT WAS MADE TO RETRIEVE AND REDEPLOY THE STENT. HOWEVER, THE STENT COULD NOT BE RETRIEVED AFTER DEPLOYMENT. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED CONTRAST AGENT RETENTION IN THE ANEURYSM LOCATED IN THE CAVERNOUS SINUS SEGMENT, WHICH WAS UNRUPTURED AND SACCULAR WITH A MAXIMUM DIAMETER OF 6 MILLIMETERS AND A NECK DIAMETER OF 4 MILLIMETERS. THE DISTAL LANDING ZONE ARTERY SIZE WAS 3.9 MILLIMETERS, AND THE PROXIMAL WAS 4.7 MILLIMETERS, WITH MODERATE VESSEL TORTUOSITY. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNIT LEVEL MET THE STANDARD. THE CUSTOMER ALLEGED SERIOUS QUALITY PROBLEMS WITH THE STENT AND REQUESTED IT BE REPORTED. THE DEVICE WAS REPLACED BY ANOTHER PRODUCT. ANCILLARY DEVICES INCLUDE: 8F CORDIS GUIDE CATHETER, MARKSMAN MICROCATHETER, SYNCHRO 14 GUIDEWIRE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT A NEARBY PED MODEL PRODUCT WAS SUBSEQUENTLY REPLACED AND THE SURGERY WAS COMPLETED. THE CAUSE OF THE SHEATH BEING IN A CLOSED STATE WAS THE PROFESSOR CONFIRMED THAT WHEN IT WAS OPENED, IT WAS IMMEDIATELY DISCOVERED THAT SHEATH WAS IN A CLOSED STATE, AND THEN IT WAS OPENED WITH SURGICAL SCISSORS. THE CAUSE OF THE RESISTANCE WAS UNKNOWN, THE PROFESSOR REPEATEDLY STRESSED THAT THE STENT COULD NOT BE RETRIEVED AND THEREFORE COULD NOT BE REPOSITIONED FOR DEPLOYMENT. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465175 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-MARKSMAN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female