BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4164372 · Received October 10, 2014

    Report

    Report Number
    3004478276-2014-00051
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 10, 2014
    Report Date
    January 16, 2015
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE IS IN THE PROCESS OF BEING EVALUATED. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE MEASURES OF A SIZE 21 MITROFLOW VALVE MODEL LXA AT THE TIME OF MANUFACTURE AND RELEASE.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS MITROFLOW VALVE WAS EXPLANTED AFTER 3 YEARS AND 8 MONTHS DUE TO A REPORTED SEVERE PROSTHETIC STENOSIS WITH REGURGITATION. LEAFLET CALCIFICATION, DETECTED WITH VISUAL, X-RAY AND HISTOLOGICAL ANALYSES, CAUSED STIFFENING AND LED TO PROGRESSIVE VALVE STENOSIS. AORTIC INSUFFICIENCY LIKELY RESULTED FROM LEAFLET TEARS AND INADEQUATE LEAFLET COAPTATION CAUSED BY CALCIFICATION OF THE LEAFLETS. AS REPORTED IN THE SCIENTIFIC LITERATURE, STRUCTURAL DYSFUNCTION IS THE MAJOR CAUSE OF FAILURE OF BIOPROSTHETIC HEART VALVES AND THE PRINCIPAL UNDERLYING PATHOLOGIC PROCESS IS CUSPAL CALCIFICATION. CALCIFICATION CAN ALSO CAUSE STENOSIS DUE TO CUSPAL STIFFENING. CALCIFIC DEPOSITS ARE USUALLY LOCALIZED TO CUSPAL TISSUE (INTRINSIC CALCIFICATION). HISTOLOGICAL ANALYSIS ALSO IDENTIFIED INFLAMMATORY CELLS AND GRAM POSITIVE AND NEGATIVE BACTERIA. THE PRESENCE OF THROMBUS DEPOSITIONS, INFLAMMATORY CELLS, AND BACTERIA COLONIES INDICATED THE ONSET OF AN INFECTIVE ENDOCARDITIS IN THE ACUTE PHASE. IT IS POSSIBLE THAT THE PATIENT'S CLINICAL HISTORY AND RISK FACTORS MAY HAVE CONTRIBUTED TO THE STRUCTURAL VALVE DETERIORATION OBSERVED IN THIS MITROFLOW VALVE.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2014 THAT A MITROFLOW AORTIC PERICARDIAL HEART VALVE (MODEL LXA, SIZE 21, S/N (B)(4)) WAS EXPLANTED AFTER 3.6 YEARS DUE TO A STRUCTURAL VALVE DETERIORATION / AORTIC STENO-INSUFFICIENCY. THE VALVE WAS REPLACED WITH A 19MM SORIN MITROFLOW AORTIC PERICARDIAL HEART VALVE.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON 15 SEPTEMBER 2014 THAT A MITROFLOW AORTIC PERICARDIAL HEART VALVE (MODEL LXA, SIZE 21, S/N (B)(4)) WAS EXPLANTED AFTER 3.7 YEARS DUE TO CALCIFICATION AND REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644310 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE SORIN GROUP CANADA INC. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention