BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 12685260 · Received October 22, 2021

    Report

    Report Number
    2015691-2021-05880
    Event Type
    Death
    Date Received
    October 22, 2021
    Date of Event
    October 1, 2009
    Report Date
    October 22, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691- 2021- 05878 AND 2015691 - 2021- 05879. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM OCTOBER 2009 AND OCTOBER 2019. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01- OCTOBER 2009) WAS USED AS THE OCCURRENCE DATE. 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 VALVES ARE: P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; AND P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE. 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. INVESTIGATION RESULTS ARE INCONCLUSIVE AS THE PATIENT AND PROCEDURAL INFORMATION WAS NOT 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. ARTICLE REFERENCE: VICTOR X MOSQUERA, ALBERTO BOUZAS-MOSQUERA, YAGO VILELA-GONZALEZ, BARBARA OUJO-GONZALEZ, CARLOS VELASCO-GARCIA, JOSE J CUENCA-CASTILLO, JOSE M HERRERA-NORENA, NON-CONTRAST TRANSOESOPHAGEAL ECHO-GUIDED TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT: 10-YEAR EXPERIENCE OF A RENOPROTECTIVE STRATEGY, INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY, VOLUME 33, ISSUE 2, AUGUST 2021, PAGES 195-202, HTTPS://DOI.ORG/10.1093/ICVTS/IVAB080. DEVICE STATUS UNKNOWN.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN (B)(6), THROUGH THE REVIEW OF THE MEDICAL ARTICLE: "NON-CONTRAST TRANSESOPHAGEAL ECHO-GUIDED TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT: 10-YEAR EXPERIENCE OF A RENOPROTECTIVE STRATEGY", CORRESPONDING AUTHOR VICTOR X. MOSQUERA, THE FOLLOWING EVENTS WERE IDENTIFIED: BETWEEN OCTOBER 2009 AND OCTOBER 2019, 236 CONSECUTIVE PATIENTS UNDERWENT TA TAVR BECAUSE OF SYMPTOMATIC SEVERE AORTIC VALVE DISEASE AT OUR INSTITUTION. AFTER TRANSAPICAL TAVR WITH SAPIEN, SAPIEN XT OR SAPIEN 3 VALVES BECAUSE OF SYMPTOMATIC SEVERE AORTIC VALVE DISEASE: AFTER HOSPITAL DISCHARGE, 6 PATIENTS PRESENTED PROSTHETIC AORTIC VALVE ENDOCARDITIS AND TWO OF THEM DIED WITHIN 10-YEARS FOLLOW-UP. SINCE 1 DEATH DUE TO VALVE ENDOCARDITIS WAS PREVIOUSLY CAPTURED, THIS COMPLAINT WILL ONLY CAPTURE 5 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582715 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death