BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA? PERICARDIAL BIOPROSTHESIS

    MDR report key: 4354033 · Received December 22, 2014

    Report

    Report Number
    2015691-2014-03093
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    August 18, 2014
    Report Date
    November 24, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. WITHOUT RETURN OF THE DEVICE THE CLINICAL OBSERVATION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. PROSTHETIC VALVE ENDOCARDITIS (PVE) IS A MICROBIAL INFECTION OCCURRING ON VALVE PROSTHESES OR ON RECONSTRUCTED NATIVE HEART VALVES AND IS A SERIOUS COMPLICATION OF CARDIAC VALVE SURGERY. IT IS WELL ESTABLISHED THAT POTENTIAL CAUSES OF PVE ARE RELATED TO SURGICAL, NOSOCOMIAL, OR PATIENT FACTORS. THE RISK OF INFECTION OF THE PROSTHETIC DEVICES IS HIGHEST DURING THE FIRST 6 WEEKS AFTER OPERATION, AS PERI-OPERATIVE ANTIBIOTIC PROPHYLAXIS MAY BE INSUFFICIENT TO PREVENT INFECTION. THE LIKELIHOOD OF DEVELOPING PVE WITHIN THE FIRST 60 DAYS OF IMPLANTATION IS APPROXIMATELY 3 PERCENT. THE INCIDENCE OF DEVELOPING PVE 60 DAYS OR MORE AFTER VALVE IMPLANTATION RANGES BETWEEN 0.1 PERCENT AND 2.3 PERCENT PER PATIENT YEAR DEPENDING ON PATIENT AGE. EDWARDS LIFESCIENCES PRODUCES AND PROVIDES STERILE TISSUE BIOPROSTHESES TO ITS CUSTOMERS BY FOLLOWING CAREFULLY DESIGNED ROBUST STERILIZATION PROCESSES. THESE MANUFACTURING PROCESSES HAVE BEEN VALIDATED AND DEMONSTRATED TO CONSISTENTLY PROVIDE A SIGNIFICANT SAFETY FACTOR FROM WHICH MICROORGANISMS COULD NOT SURVIVE. MICROBIOLOGY AND PROCESS MONITORING IS ROUTINELY REVIEWED WITHIN QUALITY SYSTEMS TO MAINTAIN STERILITY CONTROL. VALIDATED TESTING HAS DEMONSTRATED THAT MICROORGANISMS COULD NOT SURVIVE EDWARDS' MULTI-STAGE PROCESSING WITH ENHANCED STERILANT OR HEATED GLUTARALDEHYDE TERMINAL STERILANT SOLUTION. THESE MULTIPLE, REDUNDANT MANUFACTURING CONTROLS ENSURE THE STERILITY OF EDWARDS' VALVES AS PROVIDED TO CUSTOMERS. THEREFORE THE PROBABILITY OF ENDOCARDITIS RELATED TO EDWARDS' BIOPROSTHESES IS REMOTE. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A (B)(4) BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THROUGH ITS IMPLANT PATIENT REGISTRY THAT A 23MM AORTIC PERICARDIAL VALVE EXPLANTED DUE TO EARLY ENDOCARDITIS AFTER AN IMPLANT DURATION OF APPROXIMATELY 30 DAYS. IT WAS LEARNED THE PATIENT PRESENTED WITH FEBRILE SYNDROME AND IT WAS NOTED VEGETATIONS AND PARAVALVULAR LEAK WERE SEEN UNDER ECHO. HOWEVER AT EXPLANT AND THROUGH MICROBIOLOGY THESE COULD NOT BE CONFIRMED. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER 23MM BIOPROSTHETIC VALVE. THERE WAS GOOD VALVE FUNCTION AFTER IMPLANT. THE PATIENT HAS SINCE BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840770 CARPENTIER-EDWARDS® PERIMOUNT MAGNA? PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention