BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 6808976 · Received August 21, 2017

    Report

    Report Number
    2015691-2017-02566
    Event Type
    Injury
    Date Received
    August 21, 2017
    Date of Event
    May 31, 2017
    Report Date
    July 28, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THIS EVENT REVEALED THIS EVENT WAS PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT NO. 2015691-2017-02077. AS SUCH, THE INFORMATION SUBMITTED UNDER MANUFACTURER REPORT NO. 2015691-2017-02566 IS A DUPLICATE REPORT. ANY ADDITIONAL INFORMATION PERTAINING TO THE REPORTED EVENT WILL BE SUBMITTED UNDER MANUFACTURER REPORT NO. 2015691-2017-02077.

    Additional Manufacturer Narrative · 1

    THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE 510K NUMBER FOR SAPIEN, SAPIEN XT AND SAPIEN 3: P100041, P130009, AND P140031. ENDOCARDITIS IS AN INFECTION OF A NATIVE OR PROSTHETIC VALVE, IS TREATED WITH ANTIBIOTICS, AND MAY REQUIRE VALVE REPLACEMENT IF ANTIBIOTIC THERAPY IS NOT EFFECTIVE. CAUSES OF PROSTHETIC VALVE ENDOCARDITIS ARE WELL DOCUMENTED IN THE LITERATURE AND ARE TYPICALLY CLASSIFIED AS EARLY (<60 DAYS) OR LATE (>60 DAYS). EARLY PROSTHETIC VALVE ENDOCARDITIS IS USUALLY CAUSED BY PERIOPERATIVE BACTERIAL CONTAMINATION OF THE VALVE. 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. IN THIS CASE, WITH THE LIMITED INFORMATION PROVIDED, THE SOURCE OF THE INFECTION CANNOT BE CONFIRMED. THERE IS NO INDICATION THE REPORTED ENDOCARDITIS IS RELATED TO A STERILIZATION FAILURE DURING THE MANUFACTURING PROCESS OF THE SAPIEN VALVES. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED THROUGH (B)(4) AFFILIATE, APPROXIMATELY ONE MONTH POST IMPLANT OF A SAPIEN VALVE, THE PATIENT WAS ADMITTED WITH ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587972 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention