BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIELDER XT

    MDR report key: 11408490 · Received March 3, 2021

    Report

    Report Number
    3004718255-2021-00203
    Event Type
    Injury
    Date Received
    March 3, 2021
    Date of Event
    January 27, 2021
    Report Date
    February 9, 2021
    Manufacturer
    ASAHI INTECC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS CAROTID INTERVENTION WAS PERFORMED ON AN EXTREMELY TORTUOUS INTERNAL CAROTID ARTERY, WITH AN ACUTE ANGLE. A FIELDER XT WIRE WAS PLACED AND THE EMBOSHIELD NAV 6 FILTER (22438-19, LOT 0082561) WAS DEPLOYED IN THE INTERNAL CAROTID ARTERY WITHOUT ISSUE. AN ACCULINK STENT (1011344-30, LOT 0010961) WAS SUCCESSFULLY IMPLANTED, AND POSTDILATATION WAS PERFORMED USING A VIATRAC. WHILE REMOVING THE FIELDER XT, THE WIRE HAD BECOME ENTANGLED WITH THE IMPLANTED ACCULINK STENT AND STUCK BEHIND THE STENT. THE RETRIEVAL CATHETER RETRIEVED THE NAV 6 FILTER WITHOUT ISSUE, AND ALL WAS REMOVED FROM THE PATIENTS ANATOMY. DURING REMOVAL, THE FIELDER XT TIP (APPROXIMATELY 1 CM) HAD SEPARATED FROM THE DEVICE AND REMAINED BEHIND THE ACCULINK STENT WALL, APPOSED BETWEEN THE VESSEL AND STENT. THE ACCULINK STENT REMAINS IMPLANTED, WELL APPOSED TO THE VESSEL WALL AT THE INTENDED AREA, WITHOUT A DEVICE ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA AND THE PATIENT REMAINED IN STABLE CONDITION (VITALS FINE). THE SEPARATED TIP REMAINS BETWEEN THE IMPLANTED ACCULINK AND VESSEL WALL. NO FURTHER TREATMENT HAD BEEN PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301096 FIELDER XT PTCA GUIDE WIRE DQX ASAHI INTECC N/A UKN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization