BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW LXA

    MDR report key: 7705313 · Received July 19, 2018

    Report

    Report Number
    3004478276-2018-00247
    Event Type
    Injury
    Date Received
    July 19, 2018
    Date of Event
    April 11, 2018
    Report Date
    October 4, 2018
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000108
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE MITROFLOW BIOPROSTHETIC PERICARDIAL HEART VALVE, MODEL # LXA23, S/N # (B)(4), AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING AT (B)(4). THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A LXA23 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. ADDITIONAL INFORMATION RECEIVED IDENTIFIED NO FURTHER INFORMATION IS AVAILABLE. BECAUSE THE DEVICE IS NOT AVAILABLE FOR RETURN AND NO FURTHER INFORMATION IS AVAILABLE THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. IF FURTHER INFORMATION IS RECEIVED THE CASE WILL BE REASSESSED. FIELDS CHANGED.

    Additional Manufacturer Narrative · 1

    DEVICE DISPOSITION PRESENTLY UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A MITROFLOW LXA21 WAS IMPLANTED. ON (B)(6) 2018 THE DEVICE WAS EXPLANTED AND REPLACED WITH A CROWN CNA23 AORTIC HEART VALVE IMPLANT. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547190 MITROFLOW LXA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. LXA21 00896208000108

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention