BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW LXA

    MDR report key: 8834814 · Received July 28, 2019

    Report

    Report Number
    3004478276-2019-00229
    Event Type
    Injury
    Date Received
    July 28, 2019
    Date of Event
    November 7, 2016
    Report Date
    July 28, 2019
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000115
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 LIVANOVA (B)(4) CORP. 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. THE DEVICE IS NOT AVAILABLE FOR RETURN AND NO FURTHER INFORMATION IS AVAILABLE FOR THE REPORTED EVENT. THE MANUFACTURER IS UNABLE TO PERFORM ANY FURTHER INVESTIGATIONS. STRUCTURAL VALVE DETERIORATION IS A KNOWN INHERENT RISK OF FAILURE FOR BIOLOGICAL IMPLANTS. HOWEVER, BECAUSE NO FURTHER INVESTIGATIONS ARE POSSIBLE THE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A MITROFLOW LXA SIZE 23 (SN (B)(4)) ON (B)(6) 2013. AT THE TIME OF IMPLANT THE PATIENT WAS 35 YEARS OLD. ON (B)(6) 2016 THE PATIENT UNDERWENT TO A RE-OPERATION FOR THE REPLACEMENT OF THE BIOPROSTHESIS DUE TO DEGRADATION AT THE (B)(6) HOSPITAL. BASED ON THE INFORMATION AVAILABLE THE PATIENT HAD PULMONARY STENOSIS IN THE MITROFLOW VALVE (45-50 MMHG) WITH PULMONARY REGURGITATION, RIGHT CHAMBER ENLARGEMENT AND DECREASED RIGHT VENTRICLE MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628604 MITROFLOW LXA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. LXA23 00896208000115

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention