BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW LXA

    MDR report key: 7849367 · Received September 5, 2018

    Report

    Report Number
    3004478276-2018-00288
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    September 29, 2016
    Report Date
    October 26, 2018
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000092
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 CANADA 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. BECAUSE THE DEVICE WAS NOT EXPLANTED AND THUS CANNOT BE ANALYSED NO FURTHER INVESTIGATIONS ARE POSSIBLE AT THIS TIME. THE MANUFACTURER IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED GRADIENT INCREASE/STRUCTURAL VALVE DETERIORATION AT THIS TIME. IF FURTHER EVENT INFORMATION IS RECEIVED OR ANY NEW PROCEDURES OCCUR THE MANUFACTURER WILL REASSESS THE INVESTIGATION AND NOTIFY THE COMPETENT AUTHORITIES. ROOT CAUSE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    DEVICE NOT EXPLANTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A MITROFLOW LXA19 WAS IMPLANTED AS PART OF THE SURE-AVR TRIAL. ON (B)(6) 2014 THE PATIENT HAD A SERIOUS ADVERSE EVENT AS RECORDED BY THE SURE-AVR CLINICAL REGISTRY. THE PATIENT HAD ACUTE RENAL FAILURE. THIS WAS DEEMED TO BE NOT VALVE RELATED BY THE SITE. ON (B)(6) 2014 THE PATIENT HAD A 2ND SERIOUS ADVERSE EVENT AS RECORDED BY THE SURE-AVR CLINICAL REGISTRY. THE PATIENT HAD ACUTE RESPIRATORY FAILURE. THIS WAS DEEMED TO BE NOT VALVE RELATED BY THE SITE. ON (B)(6) 2014 THE PATIENT HAD A 3RD SERIOUS ADVERSE EVENT AS RECORDED BY THE SURE-AVR CLINICAL REGISTRY. THE PATIENT HAD CARDIAC ARRHYTHMIA, ATRIAL FIBRILLATION. THIS WAS DEEMED TO BE NOT VALVE RELATED BY THE SITE. THE SITE RECORDED FOLLOW-UP DATA FROM THE REFERRING PHYSICIAN ON (B)(6) 2016 WHICH INDICATED THE PATIENT HAD A RIGHT BUNDLE BRANCH BLOCK. THE PATIENTS NYHA CLASS WAS ELEVATED FROM I TO II. ON (B)(6) THE PATIENT HAD A 4TH SERIOUS ADVERSE EVENT AS RECORDED BY THE SURE-AVR CLINICAL REGISTRY. THE PATIENT WAS DIAGNOSED WITH BREAST CANCER AND RECEIVED RADIOTHERAPY AND CHEMOTHERAPY. THIS WAS DEEMED TO BE NOT VALVE RELATED BY THE SITE. ON (B)(6) 2016 THE PATIENT HAD A SERIOUS ADVERSE EVENT AS RECORDED BY THE SURE-AVR CLINICAL REGISTRY. THE PATIENT HAD STRUCTURAL VALVE DETERIORATION DUE TO STIFFENING FROM CALCIFICATION OF THE MITROFLOW VALVE. THIS WAS DEEMED TO BE SYMPTOMATIC BY THE SITE. THE SITE RECORDED FOLLOW-UP DATA FROM THE REFERRING PHYSICIAN ON (B)(6) 2017 WHICH INDICATED THE PATIENTS MEAN GRADIENT HAD ELEVATED FROM 16 TO 22 MMHG AND A 3+ CENTRAL LEAK WAS NOTED. IN ADDITION THE PATIENT HAD BEEN HOSPITALIZED FOR 25 DAYS DUE TO NON-CARDIAC REASONS AND THERE NYHA CLASS HAD BEEN ELEVATED TO III. THE SITE RECORDED FOLLOW-UP DATA FROM A YEARLY PHONE CHECKUP ON (B)(6) 2018 WHICH INDICATED THE PATIENTS MEAN GRADIENT HAD INCREASED FROM 22 TO 26 MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690277 MITROFLOW LXA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. LXA19 00896208000092

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Disability