BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 6064966 · Received October 28, 2016

    Report

    Report Number
    3004478276-2016-00131
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 20, 2016
    Report Date
    April 10, 2017
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    DYE
    UDI-DI
    00896208000092
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESIGN HISTORY RECORD REVIEW COMPLETED MAR 29, 2017. THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE MITROFLOW BIOPROSTHETIC PERICARDIAL HEART VALVE, MODEL LXA19, S/N (B)(4), WERE PULLED AND REVIEWED BY QUALITY CONTROL AT LIVANOVA (B)(4) CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A (MODEL LX) MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED A 2ND PATIENT REGISTRATION FORM (PRF) FOR AORTIC POSITION FOR SAME PATIENT. DETAILS AS FOLLOWING: LXA19 SN# (B)(4) WAS IMPLANTED ON (B)(6) 2014 AT (B)(6) AT THE AORTIC POSITION. S5-021 SN# (B)(4) WAS IMPLANTED ON (B)(6) 2016 AT (B)(6) AT THE AORTIC POSITION FOR SAME PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714835 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE LIVANOVA CANADA CORP. LXA 00896208000092

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention