BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW LXA

    MDR report key: 7615244 · Received June 19, 2018

    Report

    Report Number
    3004478276-2018-00220
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    May 7, 2018
    Report Date
    October 25, 2018
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000115
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE MITROFLOW BIOPROSTHETIC PERICARDIAL HEART VALVE, MODEL # LXA23, S/N # (B)(4) 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 LXA23 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. IF AN INFECTIOUS MICROORGANISM WAS PRESENT ON THE TISSUE VALVE BEFORE STERILIZATION, IT WOULD BE KILLED VERY EASILY BY THE LIQUID CHEMICAL STERILANT. THE STERILANT CONTAINS A MIXTURE OF GLUTARALDEHYDE, FORMALDEHYDE AND ALCOHOL, ALL OF WHICH ARE HIGHLY EFFECTIVE AGAINST MICROORGANISMS. THE MANUFACTURER HAS VALIDATED THIS LIQUID CHEMICAL STERILIZATION PROCESS WITH SPORE FORMING BACILLUS ATROPHAEUS, WHICH IS THE MOST RESISTANT MICROORGANISM KNOWN FOR ALDEHYDES. IN ADDITION, THE STERILE PACKAGING SOLUTION USED FOR SHIPMENT OF MITROFLOW VALVES IS A 4% FORMALDEHYDE SOLUTION; THE VALVES REMAIN IN THIS EXTREMELY ANTIMICROBIAL SOLUTION UNTIL THEY ARE OPENED DURING SURGERY. THEREFORE, IT IS NOT CONCEIVABLE THAT AN INFECTIOUS MICROORGANISM COULD SURVIVE ON A VALVE EXPOSED TO OUR STERILANT, OR THE PACKAGING SOLUTION. BECAUSE NO FURTHER INFORMATION IS AVAILABLE AND THE DEVICE IS NOT AVAILABLE FOR ANALYSIS NO FURTHER INVESTIGATIONS CAN BE PERFORMED AT THIS TIME. BASED ON THE TIME THAT HAD ELAPSED BETWEEN THE IMPLANT AND THE REPORTED ENDOCARDITIS, AND GIVEN THE CONFIRMATION OF THE DEVICE STERILIZATION, IT CANNOT REASONABLY BE ASSUMED THAT THE REPORTED EVENT IS A RESULT OF ANY FACTOR INTRINSIC TO THE DEVICE IN QUESTION. HOWEVER, BECAUSE NO FURTHER INVESTIGATIONS ARE POSSIBLE THE EXACT ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ANY FURTHER INFORMATION IS RECEIVED THE EVENT WILL BE REASSESSED.

    Additional Manufacturer Narrative · 1

    DEVICE DISPOSITION PRESENTLY UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS NOTIFIED OF ADDITIONAL INFORMATION ON AUG. 16, 2018. IT WAS INDICATED THAT THE PATIENT HAD ENDOCARDITIS AND THIS WAS BELIEVED TO HAVE COMPROMISED THE LXA VALVE. THIS INFORMATION HAS BEEN INCLUDED IN THE UPDATED EVENT DESCRIPTION.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A MITROFLOW LXA23 AORTIC HEART VALVE PROSTHESIS WAS IMPLANTED. THE MANUFACTURER WAS NOTIFIED OF AN IMPLANT OF A CROWN CNA23 AT THE SAME LOCATION ON MAY 7, 2018. NO FURTHER INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A MITROFLOW LXA23 AORTIC HEART VALVE PROSTHESIS WAS IMPLANTED. THE MANUFACTURER WAS NOTIFIED OF AN IMPLANT OF A CROWN CNA23 AT THE SAME LOCATION ON (B)(6) 2018. THE OPERATING ROOM TEAM NOTED THAT THE LXA VALVE MAY HAVE BEEN COMPROMISED BY THE PATIENTS ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455350 MITROFLOW LXA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. LXA23 00896208000115

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention