BEUDAMED
    FDA Adverse Event Other Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 1930345 · Received October 28, 2010

    Report

    Report Number
    3004478276-2010-00009
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    September 25, 2010
    Report Date
    October 28, 2010
    Manufacturer
    SORIN GROUP CANADA INC. MITROFLOW DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED. RESULTS: THE MFG TRAVELLER AND THE STERILIZATION RECORDS FOR THE SUBJECT VALVE WERE PULLED AND REVIEWED BY QUALITY ASSURANCE AT SORIN GROUP (B)(4), MITROFLOW DIVISION. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A SIZE 25 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. NOTE: AS PART OF THE INVESTIGATION, THE REVIEW OF THE STERILIZATION RECORDS CONFIRMED THAT THE FOUR VALVES (S/NS (B)(4)) ASSOCIATED WITH THE ENDOCARDITIS CASES AT THIS FACILITY WERE NOT PROCESSED IN THE SAME STERILIZATION LOT.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED THAT OUT OF 19 MITROFLOW VALVE IMPLANTS AT THE CUSTOMER'S FACILITY SINCE (B)(6) 2010, 4 PTS WERE DIAGNOSED WITH ENDOCARDITIS. FOR EACH CASE, STAPH EPIDERMIDIS WAS IDENTIFIED AS THE RESPONSIBLE ORGANISM. THE IMPLANTS OCCURRED IN (B)(6) 2010. ACCORDING TO THE INFO PROVIDED ON (B)(4), THE PT RECEIVING THE MITROFLOW VALVE (S/N (B)(4)) ON (B)(6) 2010, WAS DIAGNOSED WITH POSSIBLE ENDOCARDITIS AFTER BEING SEEN IN THE ED FOR SHAKING, CHILLS, AND FEVER ON (B)(6) 2010. BLOOD CULTURES WERE PERFORMED AND STAPHYLOCOCCUS EPIDERMIDIS WAS ISOLATED. A TEE WAS PERFORMED AND SHOWED NO VEGETATION AND THAT THE VALVE APPEARED OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE, HEART VALVE LWR SORIN GROUP CANADA INC. MITROFLOW DIVISION LXA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention