BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4393011 · Received January 7, 2015

    Report

    Report Number
    3004478276-2014-00072
    Event Type
    Injury
    Date Received
    January 7, 2015
    Date of Event
    November 18, 2014
    Report Date
    December 10, 2014
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS MITROFLOW VALVE WAS EXPLANTED AFTER 2 YEARS AND 5 MONTHS. THERE WAS NO EVIDENCE OF CALCIFICATION OR ENDOCARDITIS IN THE RETURNED VALVE. PANNUS TISSUE OVERGROWTH INTO THE INFLOW LUMEN CAUSED A LOW DEGREE OF STENOSIS. HISTOLOGICAL ANALYSIS SHOWED THE DEGENERATION OF COLLAGEN FIBERS, SMALL THROMBUS DEPOSITIONS AND INFLAMMATORY CELLS THROUGHOUT THE THROMBUS. 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 GENERALLY THE MOST LIKELY REASON FOR INCREASED RISK IN CHILDREN. 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 DOCUMENT REVIEW CONFIRMED THAT THE VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE MEASURES OF A SIZE 19 MITROFLOW VALVE MODEL LXA AT THE TIME OF MANUFACTURE AND RELEASE. IN ADDITION, DETAILED AND SYSTEMATIC ANALYSIS AS PART OF SORIN'S CQA REVEALED NO ADDITIONAL CLINICAL FEATURES, FINDINGS ON DIAGNOSTIC IMAGING OR FINDINGS ON PATHOLOGIC EVALUATION THAT MIGHT FURTHER BE ATTRIBUTED TO THIS OUTCOME BEYOND THE SUBSTANTIAL RISK IMPOSED BY THE PATIENT'S AGE FOR ANY IMPLANTED BIOPROSTHETIC CARDIAC VALVE. THE INSTRUCTIONS FOR USE STATE THAT PATIENTS WHO ARE 55 YEARS OF AGE OR LESS MAY EXPERIENCE ACCELERATED CALCIFICATION OF THEIR BIOPROSTHETIC VALVE. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED IN THE ATTACHED TECHNICAL REPORT.

    Additional Manufacturer Narrative · 1

    RESULT: THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE SUBJECT VALVE WERE PULLED AND BEING REVIEWED BY QUALITY CONTROL AT SORIN GROUP (B)(4). HISTOPATHOLOGICAL EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON DEC 10, 2014 THAT A MITROFLOW VALVE - AORTIC POSITION (MODEL LXA, SIZE19) WAS EXPLANTED AFTER 2.5 YEARS. IT WAS ALSO LEARNED LATER THAT ANOTHER MITROFLOW VALVE - PULMONARY POSITION (MODEL LXA, SIZE 23) WAS EXPLANTED FROM THE SAME PATIENT DURING THE SAME PERIOD. THIS MEDWATCH FORM IS FOR THE FIRST VALVE - AORTIC POSITION, MODEL LXA, SIZE 19 SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2014 THAT A MITROFLOW VALVE - AORTIC POSITION (MODEL LXA, SIZE19) WAS EXPLANTED AFTER 2.5 YEARS. IT WAS ALSO LEARNED LATER THAT ANOTHER MITROFLOW VALVE - PULMONARY POSITION (MODEL LXA, SIZE 23) WAS EXPLANTED FROM THE SAME PATIENT DURING THE SAME PERIOD. THIS MEDWATCH FORM IS FOR THE FIRST VALVE - AORTIC POSITION, MODEL LXA, SIZE 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13315 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE SORIN GROUP CANADA INC. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention