BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

    MDR report key: 5487088 · Received March 8, 2016

    Report

    Report Number
    2015691-2016-00712
    Event Type
    Injury
    Date Received
    March 8, 2016
    Date of Event
    February 16, 2016
    Report Date
    February 16, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FOUR MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. 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: 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. THE SOURCE OF THE INFECTION IS UNKNOWN. IN THIS CASE, REPORTING AND CAPTURE ARE BEING DONE CONSERVATIVELY. NO ADDITIONAL PATIENT OR PROCEDURAL FACTORS WERE PROVIDED THAT COULD HELP DETERMINE A ROOT CAUSE. 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)(4), IN THE (B)(6) SESSION A TOTAL OF 10 EDWARDS VALVES BETWEEN 2008 AND 2015 NEEDED SURGICAL EXPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED. SIX VALVES WERE EXPLANTED DUE TO ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142919 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention