BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 8388712 · Received March 4, 2019

    Report

    Report Number
    3005687633-2019-00154
    Event Type
    Death
    Date Received
    March 4, 2019
    Date of Event
    March 18, 2013
    Report Date
    March 21, 2019
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    LWR
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IF AN INFECTIOUS MICROORGANISM WAS PRESENT ON OUR TISSUE VALVE BEFORE STERILIZATION, IT WOULD BE KILLED VERY EASILY BY OUR LIQUID CHEMICAL STERILANT. THE STERILANT CONTAINS A MIXTURE OF GLUTARALDEHYDE AND ALCOHOL, BOTH OF WHICH ARE HIGHLY EFFECTIVE AGAINST INFECTIOUS MICROORGANISMS. WE HAVE VALIDATED THIS LIQUID CHEMICAL STERILIZATION PROCESS WITH SPORE FORMING BACILLUS ATROPHAEUS, WHICH IS THE MOST RESISTANT MICROORGANISM KNOWN FOR ALDEHYDES. FOLLOWING ROUTINE STERILIZATION, THE VALVES ARE ASEPTICALLY PACKAGED IN A SOLUTION THAT INHIBITS GROWTH OF MICROORGANISMS WITH STEAM STERILIZED CLOSURES AND JARS. THE PACKAGING PROCESS OCCURS IN A VAPOROUS HYDROGEN PEROXIDE (VHP) DECONTAMINATED ISOLATOR; THEREFORE THERE IS NO RISK OF VALVE CONTAMINATION POST-STERILIZATION. EACH CLOSURE/JAR CONTAINING THE VALVE IS INTEGRITY TESTED AFTER PACKAGING, THUS ENSURING A SEALED BARRIER FOR THE PRODUCT TO REMAIN STERILE DURING TRANSPORT UP UNTIL THE CLOSURE/JAR IS OPENED. DUE TO THE ABOVE REASONING, BASED ON THE VERIFICATION OF DEVICE STERILIZATION AND THE LATE ONSET OF THE ENDOCARDITIS (MORE THAN 60 DAYS AFTER THE PERCEVAL IMPLANT), IT IS UNLIKELY THAT THE PATIENT'S ENDOCARDITIS ORIGINATED FROM THE DEVICE, WHICH WAS RECORDED TO BE PROPERLY FUNCTIONING AT HOSPITAL DISCHARGE (3 MONTHS PRIOR TO THE EVENT). HOWEVER, SINCE THERE IS NO AVAILABLE INFORMATION ON THE DEVICE FUNCTIONALITY AT THE TIME OF THE EVENT (ECHO DATA FROM (B)(6) 2013 DISPLAYS N/A FOR BOTH THE MEAN GRADIENT AND THE REGURGITATION), AND BECAUSE NO FURTHER INVESTIGATION ON THE DEVICE WAS POSSIBLE, THE ROOT CAUSE OF THE EVENT REMAINS ULTIMATELY UNKNOWN.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED ABOUT THIS EVENT THROUGH THE SURE AVR STUDY DATABASE. ON (B)(6) 2012, AN 80 YEARS OLD MALE PATIENT RECEIVED A PVS25 IN AORTIC POSITION. THE PROCEDURE WAS PERFORMED IN MINI-THORACOTOMY AND NO CONCOMITANT PROCEDURES OCCURRED. AT DISCHARGE (B)(6) 2012, A GOOD VALVE FUNCTIONALITY IS REPORTED (MEAN GRADIENT IS 15MMHG, WITH NO PERIVALVULAR/CENTRAL LEAKS). ON (B)(6) 2013, THE PATIENT HAD ENDOCARDITIS (PRIMARY, MICROORGANISM UNKNOWN). IT IS ALSO REPORTED THAT THE PATIENT HAD A DISABLING STROKE ON (B)(6) 2013. IT IS NOT SPECIFIED WHAT TYPE OF TREATMENT WAS PROVIDED TO THE PATIENT. THE PATIENT ULTIMATELY DIED ON (B)(6) 2013 (CARDIOVASCULAR MORTALITY, DUE TO ENDOCARDITIS). NO AUTOPSY WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE DEVICE HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE DEVICE SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. DEVICE NOT EXPLANTED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED ABOUT THIS EVENT THROUGH THE SURE AVR STUDY DATABASE. ON (B)(6) 2012, AN (B)(6) MALE PATIENT RECEIVED A PVS25 IN AORTIC POSITION. THE PROCEDURE WAS PERFORMED IN MINI-THORACOTOMY AND NO CONCOMITANT PROCEDURES OCCURRED. AT DISCHARGE, A GOOD VALVE FUNCTIONALITY IS REPORTED (MEAN GRADIENT IS 15MMHG, WITH NO PERIVALVULAR/CENTRAL LEAKS). ON (B)(6) 2013, THE PATIENT HAD ENDOCARDITIS (PRIMARY, MICROORGANISM UNKNOWN). IT IS ALSO REPORTED THAT THE PATIENT HAD A DISABLING STROKE ON (B)(6) 2013. IT IS NOT SPECIFIED WHAT TYPE OF TREATMENT WAS PROVIDED TO THE PATIENT. THE PATIENT ULTIMATELY DIED ON (B)(6) 2013 (CARDIOVASCULAR MORTALITY, ENDOCARDITIS). NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181843 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVES LWR SORIN GROUP ITALIA S.R.L. PVS25

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| O| S