BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW LXA

    MDR report key: 7515715 · Received May 15, 2018

    Report

    Report Number
    3004478276-2018-00191
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    April 18, 2018
    Report Date
    June 19, 2018
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    UDI-DI
    00896208000122
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE MITROFLOW BIOPROSTHETIC PERICARDIAL HEART VALVE, MODEL # LXA25, S/N # (B)(4), AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING AT LIVANOVA CANADA CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A LXA25 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. THE MANUFACTURER HAS NOT RECEIVED THE DEVICE FOR ANALYSIS, TO DATE. GIVEN THE LIMITED INFORMATION PROVIDED, AND THE INABILITY TO PERFORM A DEVICE INVESTIGATION, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    A 25 MM MITROFLOW LXA WAS IMPLANTED ON (B)(6) 2010. ON (B)(6) 2018, THE VALVE WAS EXPLANTED DUE TO CRITICAL AORTIC STENOSIS. URGENT SURGERY WAS REQUIRED DUE TO RESPIRATORY COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357040 MITROFLOW LXA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP LXA25 00896208000122

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention