BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROWN PRT PERICARDIAL HEART VALVE

    MDR report key: 7574606 · Received June 6, 2018

    Report

    Report Number
    3004478276-2018-00211
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    November 30, 2017
    Report Date
    June 6, 2018
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000535
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN THE DELAYED ONSET OF THE EVENT (3 YEARS POST-IMPLANT) IT IS NOT FEASIBLE THAT THE EVENT IS RELATED TO THE STERILITY OF THE DEVICE. FURTHERMORE, THE DEVICE WAS CONFIRMED TO BE FUNCTIONING WELL AT THE TIME OF THE PATIENT'S ENDOCARDITIS. AS SUCH, THERE IS NO INFORMATION TO SUGGEST THAT THE EVENT IS RELATED TO THE DEVICE, AND NO DEVICE INVESTIGATION IS WARRANTED. FURTHERMORE, A POTENT COMBINATION OF ALDEHYDES AND ALCOHOL SOLUTIONS ARE USED TO CHEMICALLY STERILIZE ALL TISSUE VALVE PRODUCTS AT LNC. THE CHEMICAL STERILIZATION PROCESS IS CONTINUALLY VALIDATED TO DELIVER A STERILITY ASSURANCE OF LEVEL (SAL) OF 10-6. THIS MEANS A PROBABILITY OF HAVING ONE NON-STERILE PRODUCT IN ONE MILLION PRODUCTS. VALIDATION IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARD ISO14160:2011. A WORST-CASE CHEMICAL STERILIZATION PROCESS IS VALIDATED BY UTILIZING LOWER-STRENGTH STERILANT, SHORTER STERILIZATION TIMES, AND INOCULATION WITH A HIGH NUMBER (106 CFU) OF SPORE-FORMING BACTERIA (E.G. BACILLUS ATROPHAEUS). VEGETATIVE BACTERIA, SUCH AS ENTEROCOCCUS, ARE MORE SUSCEPTIBLE TO CHEMICAL STERILIZATION THAN THE BACTERIAL SPORES USED TO VALIDATE THE PROCESS. TRAINED OPERATORS WEARING CLEANROOM APPROPRIATE ATTIRE CHEMICALLY STERILIZE THE VALVES IN ENVIRONMENTS THAT ARE SEPARATED FROM AN ISO CLASS 8 CLEANROOM TO MAINTAIN ASEPSIS. MITROFLOW AND CROWN VALVES ARE CHEMICALLY STERILIZED WITHIN A VAPOROUS HYDROGEN PEROXIDE (VHP) DECONTAMINATED ISOLATOR. PERCEVAL AND SOLO VALVES ARE CHEMICALLY STERILIZED WITHIN A STEAM STERILIZED CIRCUIT WITH FILTER STERILIZED SOLUTIONS. ALL PRODUCTS ARE STERILIZED FOR A LONGER TIME THAN WHAT WAS SUCCESSFULLY VALIDATED TO ENSURE A DELIVERY OF A MINIMUM SAL OF 10-6. THIS VALIDATED CHEMICAL STERILIZATION PROCESS FOLLOWED BY A VERIFIED ASEPTIC PACKAGING STEP WITH BIOCIDAL/BIOSTATIC PACKAGING SOLUTION, AND A THOROUGH PRODUCT RELEASE PROCESS, GUARANTEE STERILITY OF ALL TISSUE VALVE PRODUCTS MANUFACTURED AT LNC. GIVEN LIVANOVA'S STERILIZATION PROCEDURE, IT IS NOT FEASIBLE THAT THE ENTEROCOCCUS SPECIES DETECTED IN THE PATIENT'S BLOOD CULTURE ORIGINATED FROM THE VALVE. FURTHERMORE, BASED ON THE DELAYED ONSET OF THE PATIENT'S ENDOCARDITIS (3 YEARS POST-IMPLANT), AND THE GOOD FUNCTIONALITY OF THE DEVICE AT THE TIME OF THE EVENT, IT CAN REASONABLY BE CONCLUDED THAT THE EVENT IS RELATED TO THE PATIENT'S SPECIFIC CLINICAL CONDITION AND NOT TO THE DEVICE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A CROWN CNA25 WAS IMPLANTED ON (B)(6) 2016, AND WAS FUNCTIONING WELL AT DISCHARGE. ON (B)(6) 2017, AN ADVERSE EVENT CLASSIFIED AS ENDOCARDITIS WAS REPORTED. THE PATIENT'S BLOOD CULTURES WERE POSITIVE FOR E. FAECALIS. ECHOCARDIOGRAPHY PERFORMED AT THE TIME OF THE EVENT SHOWED GOOD FUNCTIONALITY OF THE VALVE (MEAN GRADIENT OF 10 MMHG, NO CENTRAL OR PARAVALVULAR LEAK). ON (B)(6) "2018" THE VALVE WAS EXPLANTED DUE TO ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414666 CROWN PRT PERICARDIAL HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. CNA25 00896208000535

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R