BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW LXA

    MDR report key: 7608456 · Received June 16, 2018

    Report

    Report Number
    3004478276-2018-00217
    Event Type
    Injury
    Date Received
    June 16, 2018
    Date of Event
    May 7, 2018
    Report Date
    October 12, 2018
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE MITROFLOW BIOPROSTHETIC PERICARDIAL HEART VALVE, MODEL # LXA21, S/N # (B)(4), AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING AT LIVANOVA CANADA CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A LXA21 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE.

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF THE RECEIVED INFORMATION REGARDING THE CASE THE MANUFACTURER HAS IDENTIFIED THAT NO FURTHER INVESTIGATIONS ARE POSSIBLE BASED ON THE LIMITED INFORMATION. THE DEVICE LOCATION IS PRESENTLY UNKNOWN AND THUS THE DEVICE CANNOT BE RETURNED FOR ANALYSIS. IN ADDITION THE SITE HAS COMMENTED THAT NO FURTHER INFORMATION IS AVAILABLE. THE DHR REVIEW CONFIRMED THE DEVICE MET ALL REQUIRED STANDARDS AT THE TIME OF MANUFACTURER AND RELEASE, HOWEVER BASED ON THE LIMITED INFORMATION THE ROOT CAUSE OF THE EVENT CANNOT BE ESTABLISHED AT THIS TIME. IF FURTHER INFORMATION IS RECEIVED REGARDING THE ADVERSE EVENT THE MANUFACTURER WILL REASSESS THE INVESTIGATION. FIELDS CHANGED.

    Additional Manufacturer Narrative · 1

    DEVICE DISPOSITION PRESENTLY UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A MITROFLOW LXA21 BIOLOGICAL HEART VALVE PROSTHESIS WAS IMPLANTED. ON (B)(6) 2018 THE VALVE WAS EXPLANTED AND A PERCEVAL PVS23 WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450617 MITROFLOW LXA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. LXA21

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention