BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

    MDR report key: 7345015 · Received March 16, 2018

    Report

    Report Number
    2015691-2018-00945
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    August 1, 2017
    Report Date
    February 21, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF EVENT IS UNKNOWN, THEREFORE THE FIRST DAY THAT THE PUBLICATION WAS RECEIVED WAS NOTED.

    Additional Manufacturer Narrative · 0

    THE VALVE REMAINS IMPLANTED AND WAS THEREFORE NOT RETURNED TO EDWARDS FOR EVALUATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL CASE INFORMATION WERE MADE, HOWEVER, THE INFORMATION WAS NOT FORTHCOMING. PER THE INSTRUCTIONS FOR USE (IFU), INFECTION INCLUDING SEPTICEMIA AND ENDOCARDITIS, IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH AORTIC 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. THE EXACT SOURCE OF THE INFECTION CANNOT BE CONFIRMED WITH THE LIMITED INFORMATION THAT WAS MADE AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. DATE LISTED IS DATE ARTICLE WAS PUBLISHED. ARTICLE WAS UNCLEAR IF A SAPIEN XT OR SAPIEN 3 HAD BEEN IMPLANTED, THEREFORE THE INFORMATION PERTAINING TO BOTH WILL BE NOTED [EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 9300TFX26, PMA/510(K): P130009 & EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 9600TFX26, PMA/510(K): P140031]. INVESTIGATION IS ONGOING. BIBLIOGRAPHY: CHOURDAKIS, EMMANOUIL, ET AL. "EARLY PROSTHETIC VALVE ENDOCARDITIS AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION WITH PERIANNULAR COMPLICATION." JOURNAL OF GERIATRIC CARDIOLOGY: JGC 14.11 (2017): 711.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS AFFILIATE IN (B)(4), A JOURNAL ARTICLE TITLED, "EARLY PROSTHETIC VALVE ENDOCARDITIS AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION WITH PERIANNULAR COMPLICATION", REPORTED THAT 26 DAYS POST DEPLOYMENT OF A 26MM SAPIEN VALVE VIA TRANSFEMORAL APPROACH IN THE AORTIC POSITION DUE TO SEVERE SYMPTOMATIC AORTIC STENOSIS, THE PATIENT DEVELOPED ENDOCARDITIS. THE PATIENT WAS ADMITTED WITH SIGNS OF SEPTIC ARTHRITIS OF THE LEFT KNEE AND WAS FEBRILE. BIOCHEMISTRY REVEALED ELEVATED C-REACTIVE PROTEIN INDICATIVE OF AN ONGOING INFLAMMATORY PROCESS. THE PATIENT WAS OPERATED URGENTLY AND THE ENDOPROSTHESIS (KNEE) WAS EXPLANTED. BLOOD CULTURES DEMONSTRATED STAPHYLOCOCCUS AUREUS. ON TOE, A FLOATING MOBILE MASS WAS DETECTED WHICH WAS ATTACHED ON AORTIC BIOPROSTHESIS (SAPIEN) AND ALSO A SATELLITE-ENDOCARDITIS OF THE MITRAL VALVE AND THE AORTOMITRAL CONTINUITY. ANTIBIOTIC THERAPY WAS ADMINISTERED. DUE TO HIGH SURGICAL RISK CONSERVATIVE TREATMENT WAS FOLLOWED. IN THE NEXT THREE WEEKS, A REPEAT TOE SHOWED A FURTHER EXTENSION OF ENDOCARDITIS-LESIONS WITH MITRAL VALVE INVOLVEMENT, FORMATION OF A NEW ABSCESS-CAVITY AND A RUPTURE WITH FISTULA BETWEEN AORTIC ANNULUS AND LEFT ATRIUM. THE MITRAL REGURGITATION INCREASED WITHOUT ANY DIFFERENCE ON AORTIC REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189036 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention