BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 6203421 · Received December 23, 2016

    Report

    Report Number
    3004478276-2016-00184
    Event Type
    Death
    Date Received
    December 23, 2016
    Report Date
    December 13, 2016
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    DYE
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIMITED INFORMATION HAS BEEN PROVIDED TO THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE REQUESTED AND TESTING METHODS WILL BE DETERMINED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ON DEC 13, 2016, THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING: A PERCEVAL VALVE WAS IMPLANTED IN A PATIENT DURING AN AVR. THE PATIENT DEVELOPED ENDOCARDITIS DISEASE AND DIED AFTER REOPERATION IN ANOTHER HOSPITAL. NO FURTHER INFORMATION HAS BEEN PROVIDED THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851788 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE DYE LIVANOVA CANADA CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death