BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 5258274 · Received December 1, 2015

    Report

    Report Number
    3004478276-2015-00055
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    September 27, 2015
    Report Date
    November 2, 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
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2015 THAT MITROFLOW VALVE (LXA SIZE21) WAS EXPLANTED AFTER 4.49 YEARS DUE TO STRUCTURAL VALVE DETERIORATION. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788150 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE SORIN GROUP CANADA INC. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention