BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW LXA

    MDR report key: 7320750 · Received March 7, 2018

    Report

    Report Number
    3004478276-2018-00144
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    February 8, 2018
    Report Date
    March 28, 2018
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    UDI-DI
    00896208000108
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    LEAFLET CALCIFICATION WAS DETECTED WITH VISUAL, X-RAY AND HISTOLOGICAL ANALYSIS. VISUAL INSPECTION REVEALED THE PRESENCE OF TEARS NEAR THE POSTS ON TWO LEAFLETS. HISTOLOGICAL ANALYSIS ALSO SHOWED THE PRESENCE OF LIPID INFILTRATION (CHOLESTEROL CLEFTS) IN THE PERICARDIAL TISSUE. INFLAMMATORY CELLS WERE IDENTIFIED ON THE LEAFLETS. THERE WAS NO EVIDENCE OF ENDOCARDITIS ON THE VALVE, AS EVALUATED WITH GRAM STAINING. THE MANUFACTURING AND MATERIAL RECORDS FOR THE MITROFLOW BIOPROSTHETIC PERICARDIAL HEART VALVE, MODEL # LXA21, S/N # (B)(4), AS THEY PERTAIN TO THE REPORTED EVENT, WERE PULLED 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 LXA21 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. BASED ON THE INVESTIGATIONS PERFORMED, LEAFLET CALCIFICATION CAUSED STIFFENING OF THE LEAFLETS AND LED TO PROGRESSIVE VALVE STENOSIS. LIPID INFILTRATION MAY HAVE CONTRIBUTED TO LOCALIZED LEAFLET STIFFNESS. AORTIC INSUFFICIENCY LIKELY RESULTED FROM LEAFLET TEARING. ALTHOUGH NO RISK FACTORS FOR SVD WERE REPORTED, LIMITED INFORMATION ABOUT THE PATIENT'S CLINICAL HISTORY IS KNOWN. IT IS THEREFORE POSSIBLE THAT THE PATIENT¿S CLINICAL HISTORY AND RISK FACTORS MAY HAVE CONTRIBUTED TO THE STRUCTURAL VALVE DETERIORATION OBSERVED IN THIS MITROFLOW VALVE. HOWEVER, THE ROOT CAUSE OF THE EVENT IS ULTIMATELY UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MITROFLOW VALVE WAS EXPLANTED AFTER 4.5 YEARS WITH SIGNIFICANT STRUCTURAL VALVE DETERIORATION. NO SIGNIFICANT CARDIAC RISK FACTORS WERE REPORTED. THE PATIENT'S CORONARY ARTERIES WERE REPORTEDLY NORMAL.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR ANALYSIS ON FEBRUARY 21, 2018. THE RETURNED PROSTHESIS WAS RECEIVED IN GENERALLY GOOD CONDITION, WITH VISIBLE CALCIFICATION ON THE POSTS OF THE VALVE. THE MANUFACTURER IS IN THE PROCESS OF ATTEMPTING TO OBTAIN FURTHER INFORMATION ABOUT THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MITROFLOW VALVE WAS EXPLANTED AFTER 4.5 YEARS WITH SIGNIFICANT STRUCTURAL VALVE DETERIORATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163631 MITROFLOW LXA TISSUE HEART VALVES LWR LIVANOVA CANADA CORP LXA21 00896208000108

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention