BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS THV VALVE UNKNOWN

    MDR report key: 12562201 · Received October 1, 2021

    Report

    Report Number
    2015691-2021-05456
    Event Type
    Death
    Date Received
    October 1, 2021
    Date of Event
    April 13, 2021
    Report Date
    October 1, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2021-05450, 2015691-2021-05451, 2015691-2021-05452, 2015691-2021-05453, 2015691-2021-05454, AND 2015691-2021-05458.

    Additional Manufacturer Narrative · 1

    CITATION: URENA, MARINA, ET AL. 'CAUSES AND PREDICTORS OF MORTALITY AFTER TRANSCATHETER MITRAL VALVE IMPLANTATION IN PATIENTS WITH SEVERE MITRAL ANNULUS CALCIFICATION.' CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2021). THIS IS ONE OF SEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. THE IMPLANTED VALVE MODEL AND SIZE IS UNKNOWN. POSSIBLE VALVES USED: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE-PMA P130009 OR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE-PMA P140031. PER THE INSTRUCTIONS FOR USE (IFU), INFECTION INCLUDING SEPTICEMIA AND ENDOCARDITIS, IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH VALVE REPLACEMENT. 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, THERE WAS NO ALLEGATION OR INDICATION OF A DEVICE MALFUNCTION. WITH THE LIMITED INFORMATION PROVIDED, THE SOURCE OF THE INFECTIVE ENDOCARDITIS IS UNKNOWN BUT MAY BE RELATED TO THE MECHANISMS ABOVE. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. 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

    THROUGH REVIEW OF THE EUROPEAN ARTICLE: 'CAUSES AND PREDICTORS OF MORTALITY AFTER TRANSCATHETER MITRAL VALVE IMPLANTATION IN PATIENTS WITH SEVERE MITRAL ANNULUS CALCIFICATION', TWO PATIENTS WHO RECEIVED EITHER A SAPIEN XT OR SAPIEN 3 IN THEIR NATIVE MITRAL VALVE PRESENTED WITH INFECTIVE ENDOCARDITIS BY THEIR 30 DAY FOLLOW UPS. ONE OF THEM EXPIRED. THE CAUSE OF THE INFECTIONS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457991 EDWARDS THV VALVE UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES EDWARDS THV VALVE UNKNOWN NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R