BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROWN PRT PERICARDIAL HEART VALVE

    MDR report key: 8127101 · Received December 3, 2018

    Report

    Report Number
    3004478276-2018-00356
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    June 20, 2018
    Report Date
    January 29, 2019
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE CROWN PRT AORTIC PERICARDIAL HEART VALVE, MODEL # CNA23, S/N # (B)(6), 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 CROWN PRT AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. AS THE DEVICE REMAINS IMPLANTED, NO FURTHER INVESTIGATION COULD BE PERFORMED AND THE ROOT CAUSE OF THE EVENT CANNOT BE ESTABLISHED. HOWEVER, BASED ON THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    A CROWN CNA23 WAS IMPLANTED ON (B)(6) 2017. ON JUNE 20, 2018, A VALVE-IN-VALVE WAS PERFORMED VIA TAVR DUE TO CRITICAL STENOSIS OF THE VALVE. NO OTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS NOTIFIED OF THIS EVENT VIA THE FDA (MW5080724). NO SUBMITTER INFORMATION WAS DISCLOSED WITH THE EVENT REPORT. ADDITIONALLY, THE SERIAL NUMBER OF THE DEVICE WAS NOT REPORTED. AS SUCH, THE MANUFACTURER IS UNABLE TO IDENTIFY THE DEVICE OR THE SUBMITTER OF THE EVENT REPORT. THEREFORE, NO FOLLOW UP OR DEVICE INVESTIGATION IS POSSIBLE AND THE ROOT CAUSE CANNOT BE DETERMINED. NOT RETURNED; UNABLE TO FOLLOW UP.

    Description of Event or Problem · 1

    A CROWN CNA23 WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2018, THE VALVE WAS EXPLANTED AND REPLACED DUE TO CRITICAL STENOSIS OF THE VALVE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965499 CROWN PRT PERICARDIAL HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP CNA23

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention