BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROWN PRT PERICARDIAL HEART VALVE

    MDR report key: 7744635 · Received August 2, 2018

    Report

    Report Number
    3004478276-2018-00269
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    May 18, 2018
    Report Date
    August 24, 2018
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    UDI-DI
    00896208000511
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE CROWN PRT AORTIC PERICARDIAL HEART VALVE, MODEL#: CNA21, S/N#: (B)(4), AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING AT (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. REVIEW OF THE FUNCTION TEST VIDEO FOR THE DEVICE CONFIRMED THAT THE VALVE PERFORMED AS EXPECTED AND MET APPLICABLE FUNCTION TEST QUALITY CONTROL CRITERIA AS OUTLINED IN 450-08IP002 REV AA PRIOR TO RELEASE. NO ANOMALOUS BEHAVIOR WAS IDENTIFIED DURING THE OPEN/CLOSE CYCLES THAT COULD CONTRIBUTE TO THE REPORTED EVENT. VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED. NO ELEMENTS OF NON-CONFORMITY WERE IDENTIFIED. HYDRODYNAMIC TESTING WAS PERFORMED ON THE RETURNED DEVICE, AND CONFIRMED THAT THE VALVE MEETS ISO 5840 MINIMUM REQUIREMENTS. NO ANOMALIES WERE IDENTIFIED DURING THE OPEN/CLOSE MOTION. THE REGURGITANT FRACTION WAS WELL BELOW ISO 5840 REQUIREMENTS. BASED ON THE PERFORMED ANALYSIS, THE DEVICE CAN REASONABLY BE EXCLUDED AS A CONTRIBUTING FACTOR IN THE REPORTED EVENT. THE EVENT CANNOT BE EXPLAINED BY ANY FACTOR INTRINSIC TO THE INVOLVED DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR INVESTIGATION ON JULY 23, 2018. GROSS EXAMINATION CONFIRMED THAT THE RETURNED PROSTHESIS IS IN GENERALLY GOOD CONDITION. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    WHEN WEANING FROM BYPASS AFTER MITROFLOW VALVE IMPLANT, CENTRAL LEAK WAS IDENTIFIED VIA TEE. THE RIGHT CORONARY LEAFLET SEEMED TO BE STIFF AND DID NOT COAPT DURING DIASTOLE. CPB WAS RESUMED, AND THE VALVE WAS EXAMINED. NO DEFECTS WERE IDENTIFIED, AND NOTHING WAS IDENTIFIED THAT MIGHT BE INTERFERING WITH THE LEAFLET'S MOBILITY. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER MITROFLOW VALVE OF THE SAME SIZE. THE PATIENT WAS WEANED FROM BYPASS, AND THE PATIENT RECOVERED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585555 CROWN PRT PERICARDIAL HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP CNA21 00896208000511

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention