BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROWN PRT PERICARDIAL HEART VALVE

    MDR report key: 7007036 · Received November 7, 2017

    Report

    Report Number
    3004478276-2017-00183
    Event Type
    Injury
    Date Received
    November 7, 2017
    Date of Event
    October 5, 2017
    Report Date
    December 22, 2017
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    UDI-DI
    00896208000535
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PARTIAL MANUFACTURING AND MATERIAL RECORDS FOR THE CROWN PRT AORTIC PERICARDIAL HEART VALVE, MODEL # CNA25, S/N #(B)(4), WERE PULLED 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 CROWN PRT AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. VISUAL EXAMINATION OF THE RETURNED VALVE REVEALED DAMAGE TO THE PROSTHESIS INCLUDING A LEAFLET TEAR AND CUTS RELATED TO THE SURGICAL PROCEDURE. THE LEAFLET TEAR LIKELY CAUSED A MINOR DEGREE OF INSUFFICIENCY, AND SOME THROMBUS DEPOSITION. X-RAY ANALYSIS SHOWED NO CALCIFICATION OF THE VALVE. HISTOLOGICAL ANALYSIS REVEALED THE PRESENCE OF INFLAMMATORY CELLS, THROMBUS DEPOSITIONS, AND GRAM-POSITIVE BACTERIA INSIDE THE PERICARDIUM, INDICATING THE ONSET OF INFECTIVE ENDOCARDITIS IN THE ACUTE PHASE. THE INVESTIGATIONS PERFORMED REVEALED THE ABSENCE OF STRUCTURAL VALVE DETERIORATION OR OTHER INDICATORS OF VALVE FAILURE. THE THROMBUS FORMATION REQUIRING VALVE EXPLANT IS THEREFORE LIKELY ATTRIBUTABLE TO INFECTION AND PATIENT FACTORS, ALTHOUGH LIMITED PATIENT INFORMATION WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THIS DEVICE WAS IMPLANTED IN A (B)(6) PATIENT. A BIOLOGICAL VALVE WAS ORIGINALLY CHOSEN BY THE PATIENT AFTER BEING PRESENTED WITH THE OPTION OF BIOLOGICAL OR MECHANICAL OPTION. AS PER CROWN PRT IFU-WARNING AND PRECAUTIONS "CLINICAL EXPERIENCE DESCRIBED IN THE MEDICAL LITERATURE SUGGESTS THAT JUVENILE PATIENTS OR PATIENTS WHO ARE UNDERGOING CHRONIC HEMODIALYSIS, WHO HAVE PARATHYROID DISEASE OR IMPAIRED CALCIUM METABOLISM, OR WHO ARE 55 YEARS OF AGE OR LESS MAY EXPERIENCE ACCELERATED CALCIFICATION OF BIOPROSTHETIC HEART VALVES." DEVICE NOT YET RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING EVENT: A CROWN PRT PERICARDIAL HEART VALVE SIZE 25MM THAT WAS IMPLANTED ON (B)(6) 2017 WAS EXPLANTED ON (B)(6) 2017 DUE TO THROMBOSIS. PRIOR TO EXPLANT THE PATIENT PRESENTED WITH FEVER, CLOTS IN LEGS AND SHORTNESS OF BREATH. PATIENT MEDICATION INCLUDED ELOQUIS THEN ASPIRIN. THE PATIENT WAS OF NORMAL BODY HABITUS AS PER PHYSICIAN. ALL BLOOD CULTURES PERFORMED WERE (B)(6) AND THERE WAS NO EVIDENCE OF ENDOCARDITIS. AFTER EXPLANT OF THE CROWN DEVICE A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE SIZE (B)(6) WAS THEN IMPLANTED. THE PATIENT IS ON ECMO AT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786744 CROWN PRT PERICARDIAL HEART VALVE TISSUE HEART VALVES LWR LIVANOVA CANADA CORP CNA25 00896208000535

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R