BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4014608 · Received August 18, 2014

    Report

    Report Number
    3004478276-2014-00044
    Event Type
    Injury
    Date Received
    August 18, 2014
    Date of Event
    July 15, 2014
    Report Date
    January 12, 2015
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS REVIEW SHOWED THAT THE VALVE AT THE TIME OF MANUFACTURING AND RELEASE MET ALL THE CRITERIA NEEDED FOR THIS VALVE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4). PERFORMED A DEVICE HISTORY RECORDS REVIEW AND CONFIRMED THAT THE ABOVE-MENTIONED VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR LXA23 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, OUR INVESTIGATION WAS LIMITED TO A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE AND NO FURTHER INFORMATION IS AVAILABLE. HOWEVER IF THE VALVE IS RETURNED, THE COMPANY WOULD STILL BE INTERESTED IN CONDUCTING AN ANALYSIS OF THE EXPLANT.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) INC. PERFORMED A DEVICE HISTORY RECORDS REVIEW AND CONFIRMED THAT THE ABOVE-MENTIONED VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR LXA23 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, OUR INVESTIGATION WAS LIMITED TO A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE AND NO FURTHER INFORMATION IS AVAILABLE. HOWEVER IF THE VALVE IS RETURNED, THE COMPANY WOULD STILL BE INTERESTED IN CONDUCTING AN ANALYSIS OF THE EXPLANT.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON17 JUL 2014 THAT A MITROFLOW VALVE (MODEL LXA, SIZE23) WAS EXPLANTED AFTER 4.3 YEARS DUE TO STENO-INSUFFICIENCY.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON17 JUL 2014 THAT A MITROFLOW VALVE (MODEL LXA, SIZE23) WAS EXPLANTED AFTER 4.3 YEARS DUE TO STENO-INSUFFICIENCY.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2014 THAT MITROFLOW VALVE (LXA SIZE23) WAS EXPLANTED AFTER 4.3 YEARS DUE TO STENO-INSUFFICIENCY. THE SURGEON REPORTED THE PRESENCE OF FIBROTIC DEGENERATION ON THE VALVE WITH TEAR ON THE NON-CORONARY CUPS AT RIGHT COMMISSURAL LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495032 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE SORIN GROUP CANADA INC. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention