BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITROFLOW LXA

    MDR report key: 8837280 · Received July 29, 2019

    Report

    Report Number
    3004478276-2019-00230
    Event Type
    Death
    Date Received
    July 29, 2019
    Date of Event
    March 29, 2017
    Report Date
    July 28, 2019
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000092
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE MITROFLOW BIOPROSTHETIC PERICARDIAL HEART VALVE, MODEL # LXA19, S/N # (B)(4), AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING AT LIVANOVA (B)(4) CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A LXA19 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. THE DEVICE IS NOT AVAILABLE FOR RETURN AND NO FURTHER INFORMATION IS AVAILABLE FOR THE REPORTED EVENT. THE MANUFACTURER IS UNABLE TO PERFORM ANY FURTHER INVESTIGATIONS. STRUCTURAL VALVE DETERIORATION IS A KNOWN INHERENT RISK OF FAILURE FOR BIOLOGICAL IMPLANTS. HOWEVER, BECAUSE NO FURTHER INVESTIGATIONS ARE POSSIBLE THE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A MITROFLOW LX19 (SN (B)(4)) ON (B)(6) 2013. THE PATIENT DEATH WAS REPORTED TO BE RELATED TO THE PREMATURE FAILURE OF THE MITROFLOW VALVE. MEDICAL RECORDS REPORTED FROM (B)(6) MEDICAL CENTER REPORTED THAT THE VALVE FAILURE WAS DUE SEVERE VALVE CALCIFICATION AND LEAFLETS FIXED. ON (B)(6) 2017 TOE REPORTED THAT ¿ THE AORTIC VALVE LEAFLETS ARE SEVERELY THICKENED WITH REDUCED SYSTOLIC EXCURSION. SEVERE AORTIC CALCIFICATION IS VISUALIZED. MEAN GRADIENT WAS REPORTED TO BE 97MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630036 MITROFLOW LXA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. LXA19 00896208000092

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H