BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4393072 · Received January 7, 2015

    Report

    Report Number
    3004478276-2014-00073
    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

    RESULT: REVIEW OF THE DEVICE HISTORY RECORD WILL BE CONDUCTED BY QUALITY CONTROL AT SORIN GROUP (B)(4). HISTOPATHOLOGICAL EVALUATION WILL BE PERFORMED UPON RECEIPT OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    CONCLUSION = THIS MITROFLOW VALVE WAS EXPLANTED AFTER 2 YEARS AND 5 MONTHS DUE TO RE-OPERATION. THERE WAS NO EVIDENCE OF CALCIFICATION OR ENDOCARDITIS IN THE RETURNED VALVE. PANNUS OVERGROWTH OBSERVED IN THIS VALVE AFFECTED LEAFLET MOVEMENT AND CAUSED THE VALVE STENOSIS. PANNUS TISSUE OVERGROWTH INTO THE INFLOW LUMEN ALSO CONTRIBUTED TO STENOSIS. HISTOLOGICAL ANALYSIS SHOWED INFLAMMATORY CELLS THROUGHOUT THE SAMPLE. THE DEVICE HISTORY RECORDS REVIEW CONFIRMED THAT THE VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE MEASURES OF A SIZE 23 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 CLEARLY STATE THAT THE MITROFLOW VALVE MODEL LX "IS INTENDED FOR THE REPLACEMENT OF DISEASED, DAMAGED OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVE." THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED IN THE ATTACHED TECHNICAL REPORT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13844 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