BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 6823919 · Received August 28, 2017

    Report

    Report Number
    2015691-2017-02646
    Event Type
    Injury
    Date Received
    August 28, 2017
    Date of Event
    September 30, 2014
    Report Date
    August 10, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVE ARE LISTED BELOW. P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT¿ TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE WITH COMMANDER DELIVERY SYSTEM (TF INDICATION). 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, THE EXACT SOURCE OF THE INFECTION IS UNKNOWN. NO ADDITIONAL PATIENT OR PROCEDURAL FACTORS WERE PROVIDED. 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

    AS REPORTED BY OUR AFFILIATES IN (B)(6), AS PER ARTICLE "TRANSCATHETER AORTIC VALVE IMPLANTATION WITH A GIANT VEGETATION SUCCESSFULLY TREATED WITH ANTIBIOTICS: INSIGHTS INTO A NEW GROUP OF PATIENTS WITH ENDOCARDITIS", A (B)(6) MALE PRESENTED WITH FEVER. ONE MONTH BEFORE ADMISSION, THE PATIENT HAD UNDERGONE A TRANSCATHETER TRANSFEMORAL IMPLANTATION OF AN EDWARDS SAPIEN 26 MM PROSTHESIS. THE PERIPROCEDURAL COURSE WAS COMPLICATED BY AN ENTEROCOCCUS FAECALIS BACTEREMIA IN THE CONTEXT OF ABDOMINAL PAIN AND COLELITHIASIS. PATIENT WAS TREATED WITH GENTAMICIN, AMPICILLIN AND METRONIDAZOLE, AND DISCHARGED IN GOOD CONDITION. TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED A LARGE OSCILLATING VEGETATION ATTACHED TO THE PROSTHETIC NON-CORONARY CUSP. ANTIBIOTIC TREATMENT WITH CEFTRIAXONE AND AMPICILLIN WAS STARTED AND A CONSERVATIVE APPROACH WAS DECIDED. THE CLINICAL EVOLUTION WAS SATISFACTORY, WITH DISAPPEARANCE OF FEVER AND NEGATIVE BLOOD CULTURES IN 48 H. AT ONE WEEK DISAPPEARANCE OF THE ENORMOUS VEGETATION. PATIENT WAS DISCHARGED AFTER FOUR WEEKS OF ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604000 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention