BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW LXA

    MDR report key: 7429822 · Received April 13, 2018

    Report

    Report Number
    3004478276-2018-00174
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    October 29, 2015
    Report Date
    April 13, 2018
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    UDI-DI
    00896208000092
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE MITROFLOW BIOPROSTHETIC PERICARDIAL HEART VALVE, MODEL # LXA19, S/N (B)(4), AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING AT LIVANOVA (B)(4) CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A LXA19 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. AS THE DEVICE WAS NOT RECEIVED FOR ANALYSIS, NO FURTHER INVESTIGATION CAN BE PERFORMED. BASED ON THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICITS WERE IDENTIFIED. HOWEVER, AS THE DEVICE WAS NOT RECEIVED FOR ANALYSIS AND LIMITED EVENT INFORMATION WAS PROVIDED, THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    A MITROFLOW LXA19 WAS IMPLANTED ON (B)(6) 2012. ON (B)(6) 2015, THE VALVE WAS EXPLANTED AND REPLACED WITH A CROWN CNA19 VALVE. NO FURTHER INFORMATION ABOUT THE EVENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271661 MITROFLOW LXA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP LXA19 00896208000092

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R