BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW LXA

    MDR report key: 7378456 · Received March 28, 2018

    Report

    Report Number
    3004478276-2018-00158
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    March 1, 2018
    Report Date
    April 18, 2018
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    UDI-DI
    00896208000115
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.

    Additional Manufacturer Narrative · 1

    GROSS EXAMINATION OF THE RETURNED PROSTHESIS REVEALED DEFORMATION OF THE PROSTHESIS DUE TO INTRINSIC AND VEGETATING CALCIFICATION IN ALL LEAFLETS, AND A TEAR ON ONE OF THE LEAFLETS. PANNUS WAS PRESENT ON THE INFLOW SEWING RING OF THE VALVE. X-RAY ANALYSIS SHOWED LARGE, INTRINSIC CALCIFICATIONS IN ALL LEAFLETS. VISUAL EXAMINATION CONFIRMED THE PRESENCE OF A TEAR NEAR ONE OF THE POSTS. THE LEAFLETS WERE THICKENED DUE TO INTRINSIC AND VEGETATING CALCIFICATION, AND FOLDS WERE VISIBLE DUE TO IMPROPER LEAFLET MOTION DUE TO CALCIUM DEPOSITS. HISTOLOGICAL ANALYSIS ALSO SHOWED THICKENED LEAFLETS DUE TO INTRINSIC AND VEGETATING CALCIFICATION. HOMOGENATION OF THE COLLAGEN BUNDLES WAS EVIDENT. INFLAMMATORY CELLS WERE PRESENT ON TWO OF THE LEAFLETS, AND FIBROUS PANNUS DEPOSITION WAS VISIBLE ON THE MESOTHELIAL SURFACE OF ONE LEAFLET. FOCAL GRAM + BACTERIAL WAS PRESENT. AORTIC INSUFFICIENCY LIKELY RESULTED FROM A LEAFLET TEAR AND INADEQUATE LEAFLET COAPTATION DUE TO CALCIFICATION OF THE LEAFLETS. THERE WAS NO EVIDENCE OF ENDOCARDITIS IN THE RETURNED VALVE. STRUCTURAL DYSFUNCTION IS THE MAJOR CAUSE OF FAILURE OF BIOPROSTHETIC HEART VALVES, AND THE PRINCIPAL UNDERLYING PATHOLOGICAL PROCESS IS CUSPAL CALCIFICATION. CALCIFICATION CAN ALSO CAUSE STENOSIS DUE TO CUSPAL STIFFENING. CALCIFIC DEPOSITS ARE USUALLY LOCALIZED TO CUSPAL TISSUE (INTRINSIC CALCIFICATION). THE PATIENT'S CLINICAL CONDITIONS AND RISK FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT; HOWEVER, AS LIMITED PATIENT HISTORY WAS PROVIDED THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    A MITROFLOW LXA 23 MM VALVE WAS EXPLANTED AND REPLACED WITH PERCEVAL 23 MM VALVE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220423 MITROFLOW LXA TISSUE HEART VALVES LWR LIVANOVA CANADA CORP LXA23 00896208000115

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R