BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 5156011 · Received October 16, 2015

    Report

    Report Number
    3004478276-2015-00047
    Event Type
    Injury
    Date Received
    October 16, 2015
    Date of Event
    September 16, 2015
    Report Date
    September 19, 2015
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER IS SELECTED SINCE DEVICE IS NOT RETURNED TO MANUFACTERER YET. NO FURTHER INFORMATION WAS PROVIDED. UNKNOWN IF DEVICE WILL BE RETURNED

    Additional Manufacturer Narrative · 1

    (B)(4). BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS LIVANOVA'S INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORDS AND SCIENTIFIC LITERATURE REVIEW. THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE SUBJECT VALVE WERE PULLED AND REVIEWED BY QUALITY CONTROL AT LIVANOVA (B)(4) CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A LXA19 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. THE MEDICAL LITERATURE CLEARLY STATES THAT CHILDREN IN THIS AGE GROUP ARE AT SIGNIFICANT RISK FOR RAPID DETERIORATION OF IMPLANTED BIOPROSTHETIC CARDIAC VALVES DUE TO EXUBERANT FIBROUS PANNUS FORMATION AND DYSTROPHIC CALCIFICATION OF THE VALVE LEAFLETS. HIGH CALCIUM TURNOVER ACCOMPANYING BONE GROWTH IS THE MOST LIKELY REASON FOR INCREASED RISK IN CHILDREN GENERALLY . THE MEDICAL LITERATURE CONSISTENTLY STATES THAT THE RISK OF RAPID DETERIORATION OF AN IMPLANTED BIOPROSTHETIC VALVE ARE HIGH ALTHOUGH DUE TO PHYSIOLOGIC VARIABILITY FOR THESE PREDISPOSING METABOLIC PROCESSES, THE RATE OF DETERIORATION IN A GIVEN PATIENT ARE DIFFICULT TO PREDICT . THE DEVICE WAS IMPLANTED IN A (B)(6) PATIENT. THE INSTRUCTIONS FOR USE STATE THAT THE PATIENTS UNDER 55 YEARS OF AGE MAY EXPERIENCE ACCELERATED CALCIFICATION OF BIOPROSTHETIC DEVICES. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2015 THAT MITROFLOW VALVE (LXA SIZE19) WAS EXPLANTED AFTER 2.2 YEARS DUE TO VALVE DETORIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686262 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE SORIN GROUP CANADA INC. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention