BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 4213039 · Received October 24, 2014

    Report

    Report Number
    3004193842-2014-00002
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 20, 2014
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN "(B)(6) FEMALE PT WITH AORTIC VALVE DISEASE/MALFUNCTION IN CT INSPECTION HIGHLY TORTUOUS DESCENDING AORTA AND DILATED AORTIC ARCH AREA. DECIDED TO BE TREATED WITH TAVR BY LOTUS VALVE SYSTEM 25MM (LOT14167020), USING ALSO LOTUS LARGE INTRODUCER SET (LOT DS12508) AND ALSO SAFARI SMALL PRE-SHAPED TAVR/TAVI WIRE 300CM (LOT 10425869). PT HAS VERY TORTUOUS ANATOMY FROM FEMORAL AREA ALL WAY TO AORTIC ARCH. AFTER SUCCESSFUL INSERTION WITH LOTUS DEVICE, TEAM MANAGED TO GET LOTUS THROUGH 3 DIFFERENT ANGLES IN DESCENDING AORTA. THEN IN BEGINNING OF AORTIC ARCH NOT POSSIBLE TO GET LOTUS SYSTEM CROSSING AORTIC ARCH. AFTER SEVERAL ATTEMPTS, DECIDED TO STOP PROCEDURE AND LOTUS SYSTEM TAKEN OUT SUCCESSFULLY. AFTER THIS SMALL DISSECTION IN TOP OF AORTIC ARCH SEEN IN ANGIO, DECIDED NOT TO CONTINUE WITH TAVR PROCEDURE. LOTUS INTRODUCER TAKEN OUT AND VESSEL CLOSURE DONE SUCCESSFULLY. PT STABLE DURING AND AFTER PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678073 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA-TACTX MEDICAL NTR20 DS12508

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention