BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 19085394 · Received April 10, 2024

    Report

    Report Number
    2015691-2024-02765
    Event Type
    Death
    Date Received
    April 10, 2024
    Report Date
    April 11, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103195040
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), INFECTIONS SUCH AS SEPTICEMIA AND ENDOCARDITIS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE THV PROCEDURE. 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). THE TWO CATEGORIES SHOW DEFINITE DIFFERENCES IN CLINICAL FEATURES, MICROBIAL PATTERNS, AND MORTALITY. EARLY PROSTHETIC VALVE ENDOCARDITIS IS USUALLY CAUSED BY PERIOPERATIVE BACTERIAL CONTAMINATION OF THE VALVE. IN EARLY CASES OF PROSTHETIC ENDOCARDITIS, SUBSEQUENT INFECTIONS ARE ALMOST UNIVERSALLY RELATED TO CONTAMINATION AT THE TIME OF SURGERY. IF THERE WERE EVER NONCONFORMANCES IN THE STERILITY OR PACKAGING PROCESSES, THEY WOULD MOST LIKELY MANIFEST IN THE EARLY POST-OPERATIVE PERIOD. CONSIDERING THIS, ONLY REPORTS OF PROSTHETIC ENDOCARDITIS OCCURRING WITHIN 60 DAYS OF IMPLANT, WITHOUT A KNOWN SOURCE OF INFECTION, WOULD BE MDR REPORTABLE. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY WRITTEN BY EW, EARLY PROSTHETIC VALVE ENDOCARDITIS OCCURRING WITHIN 60 DAYS OF VALVE IMPLANTATION GENERALLY REFLECTS CONTAMINATION ARISING IN THE PERIOPERATIVE PERIOD. THERE ARE MANY OPPORTUNITIES FOR ORGANISMS TO SEED A PROSTHESIS PERIOPERATIVELY, MOST CONTAMINATION PROBABLY OCCURS INTRAOPERATIVELY. EDWARDS LIFESCIENCES PRODUCES AND PROVIDES STERILE TISSUE BIOPROSTHESIS 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' BIOPROSTHESIS IS REMOTE. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE THAT UNKNOWN PATIENT FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE JAPANESE TAVI REGISTRY, A 26MM SAPIEN 3 VALVE WAS TRANSFEMORALLY DEPLOYED IN THE AORTIC ANNULUS. TWO (2) MONTHS AFTER THE TAVR PROCEDURE, THE PATIENT DEVELOPED SEPTIC SHOCK. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED NO OBVIOUS VEGETATION, BUT AN ECHO-FREE SPACE WAS FOUND IN THE VALVE ANNULUS. AN ANNULAR ABSCESS WAS SUSPECTED, AND INFECTIVE ENDOCARDITIS (IE) WAS OBSERVED (THE EXACT OCCURRENCE DATE OF IE WAS UNKNOWN). DUE TO DECREASED ACTIVITIES OF DAILY LIVING (ADL), SURGERY WAS DIFFICULT, SO CONSERVATIVE TREATMENT WITH ANTIBIOTICS WAS PERFORMED FOR IE AND SEPSIS SHOCK. DUE TO DECREASED ADL, HE WAS TRANSFERRED TO A CONVALESCENT HOSPITAL. SIX (6) MONTHS POST-TAVR PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REPORTED AS INFECTION. PER MEDICAL OPINION, THE DEATH WAS RELATED TO THE DEVICE BUT UNKNOWN TO THE TAVI PROCEDURE. THE DEVICE REMAINS IMPLANTED IN THE PATIENT'S BODY AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691117 SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26J 00690103195040

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| D