BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW LXA

    MDR report key: 8317656 · Received February 7, 2019

    Report

    Report Number
    3004478276-2019-00121
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    August 25, 2014
    Report Date
    February 7, 2019
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000122
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE IS PART OF CAPA (B)(4) EVENTS IDENTIFIED AS POSSIBLE COMPLAINT RELATED TO VALVE RE-INTERVENTION. NO FURTHER EVENT DETAILS WERE PROVIDED. THIS CASE IS BEING REPORTED TO FDA IN A CONSERVATIVE WAY, AND NO POSSIBLE INVESTIGATION WILL BE PERFORMED AT THIS TIME. VALVE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO A MITROFLOW VALVE LXA25 IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH A MITROFLOW VALVE DLA23 ON (B)(6) 2014. NO FURTHER EVENT DETAILS WERE PROVIDED. THIS CASE IS BEING REPORTED TO FDA IN A CONSERVATIVE MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110363 MITROFLOW LXA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. LXA25 00896208000122

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention