BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 6049311 · Received October 21, 2016

    Report

    Report Number
    3004478276-2016-00120
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 21, 2016
    Report Date
    July 26, 2017
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    DYE
    UDI-DI
    00896208000528
    PMA / PMN Number
    P060038/S026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE CROWN PRT AORTIC PERICARDIAL HEART VALVE, MODEL CNA23, 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 CROWN PRT AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. THE VISUAL INSPECTION PERFORMED ON THE RETURNED PROSTHESIS CONFIRMED THE ABSENCE OF MANUFACTURING DEFECTS. THE HYDRODYNAMIC TESTING CONDUCTED ON THE RETURNED PROSTHESIS CONFIRMED THAT THE DEVICE WAS SHOWING A NORMAL LEAFLET KINEMATICS WITH A REGURGITATION FRACTION IN COMPLIANCE WITH REQUIREMENT OF EN ISO (B)(4). BASED ON THE PERFORMED ANALYSIS, THE REPORTED EVENT CANNOT BE EXPLAINED BY ANY FACTOR INTRINSIC IN THE INVOLVED DEVICE.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED ON 21 SEP 2016 ABOUT THE FOLLOWING EVENT: AFTER SPONTANEOUS CIRCULATION WAS RESUMED FOLLOWING VALVE REPLACEMENT, REGURGITATION OCCURRED: ON (B)(6) 2016: AN AORTIC VALVE REPLACEMENT PROCEDURE WAS STARTED FOR THE PATIENT, WHO WAS DIAGNOSED WITH AORTIC REGURGITATION AND AS BEING SUSPICIOUS FOR TAKAYASU'S ARTERITIS; AS THE 25-MM SIZER WAS ABLE TO PASS THROUGH THE PATIENT'S ANNULUS, THE CNA23 MODEL WAS SELECTED; AFTER THE PATIENT WAS CONFIRMED TO HAVE TAKAYASU'S ARTERITIS, THE CROWN PRT CNA23 WAS IMPLANTED USING EVERTING MATTRESS SUTURE TECHNIQUE; AFTER THE PATIENT'S SPONTANEOUS CIRCULATION WAS RESUMED, AORTIC REGURGITATION OCCURRED AND THE PATIENT HAD VENTRICULAR TACHYCARDIA. THE RIGHT CORONARY CUSP OF THE VALVE APPEARED TO BE DEFORMED AND SHOWED ABNORMALITY IN ITS MOTION. REGURGITATION FROM THE RIGHT SIDE OF THE VALVE WAS CONFIRMED; WITH EXTRACORPOREAL CIRCULATION STARTED AGAIN, THE CROWN PRT VALVE WAS EXPLANTED. THE PATIENT'S AORTIC WALL WAS WEAK, AND A TEAR WAS FOUND ON THE RIGHT SIDE OF THE AORTIC WALL. THE LENGTH OF THIS TEAR WAS CORRESPONDING TO ONE STITCH OF THE SUTURE THAT WAS SEWN TO IMPLANT THE CROWN PRT VALVE; CROWN PRT VALVE, SIZE 23 WAS EXPLANTED AND MAGNA EASE 23 MM WAS IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699647 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE LIVANOVA CANADA CORP. CNA 00896208000528

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention