BEUDAMED
    FDA Adverse Event Other Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4284195 · Received August 19, 2014

    Report

    Report Number
    3004478276-2013-00011
    Event Type
    Other
    Date Received
    August 19, 2014
    Date of Event
    June 26, 2013
    Report Date
    October 10, 2013
    Manufacturer
    SORIN GROUP CANADA INC., MITROFLOW DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT RETURNED AT THE MOMENT. METHOD - THE DEVICE HISTORY RECORD REVIEW WILL BE PERFORMED. MORPHO-HISTOLOGICAL ANALYSIS WILL BE PERFORMED ON THE VALVE. RESULTS - NO DEFINITIVE RESULTS AT THIS TIME. CONCLUSION - NO CONCLUSION CAN BE DRAWN AT THIS TIME AS DEVICE IS CURRENTLY IN THE PROCESS OF BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2013 OF A MITROFLOW VALVE (LXA SIZE 25) THAT WAS EXPLANTED AFTER 3 MONTHS DUE TO VALVE DYSFUNCTION. THE EXPLANT OCCURRED ON (B)(6) 2013. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MITROFLOW LXA (SIZE 23) BIOPROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497415 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE, HEART VALVE LWR SORIN GROUP CANADA INC., MITROFLOW DIVISION LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention