BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN M3 VALVE

    MDR report key: 17623907 · Received August 25, 2023

    Report

    Report Number
    2015691-2023-15473
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    July 26, 2023
    Report Date
    November 22, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    UDI-DI
    00690103214291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THE REPORTABILITY OF THE EVENT PREVIOUSLY REPORTED DUE TO RECEIPT OF MEDICAL RECORDS. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN CORRECTED/UPDATED: B2 (OUTCOMES ATTRIBUTED TO ADVERSE EVENTS), B7 (OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS), H6 (HEALTH EFFECT - IMPACT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) AND H10 (PROVIDE NARRATIVE/DATA). ADDITIONAL INFORMATION WAS RECEIVED VIA MEDICAL RECORDS REVEALING APPROXIMATELY 31 DAYS POST TMVR PROCEDURE, THE PATIENT HAD A DOG SCRATCH ON THEIR LEFT HAND THAT BROKE THE SKIN AND BLED. BLOOD CULTURES WERE PERFORMED APPROXIMATELY 61 DAYS POST TMVR PROCEDURE REVEALING THERE WAS BACTEREMIA THAT WAS IDENTIFIED AS STREPTOCOCCUS AGALACTIAE. METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) WAS NOTED TO BE NEGATIVE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS ALSO PERFORMED AND REVEALED A SMALL MOBILE ECHO DENSITY ATTACHED TO THE MITRAL VALVE. IT WAS SUSPECTED TO BE ENDOCARDITIS. THE PATIENT WAS TREATED MEDICALLY. THE CAUSES OF PROSTHETIC VALVE ENDOCARDITIS (PVE) ARE WELL DOCUMENTED IN THE LITERATURE AND ARE TYPICALLY CLASSIFIED AS EARLY (LESS THAN 60 DAYS) OR LATE (GREATER THAN 60 DAYS). IN EARLY CASES OF PVE, SUBSEQUENT INFECTIONS MAY BE RELATED TO CONTAMINATION AT THE TIME OF SURGERY (POOR STERILE TECHNIQUE). OTHER CAUSES OF EARLY PVE CAN OCCUR FROM OTHER SOURCES OF INFECTION AND NOT FROM THE VALVE. ADDITIONALLY, A NON-CONFORMANCE IN THE STERILITY OR PACKAGING PROCESSES OF THE VALVE MAY ALSO MANIFEST IN THE EARLY POST-OPERATIVE PERIOD CAUSING EARLY PVE. HOWEVER, THERE ARE SEVERAL TYPES OF BACTERIA THAT WOULD NOT SURVIVE THE EDWARDS STERILIZATION PROCESS. A MEMO PROVIDED BY EDWARDS MICROBIOLOGY CONFIRMED STREPTOCOCCUS AGALACTIAE WOULD NOT BE ABLE TO SURVIVE THE STERILIZATION PROCESS. IT CAN BE CONCLUDED THAT THE SEALED PACKAGE CONTAINING THE BIOPROSTHETIC VALVE, AS SUPPLIED BY EDWARDS LIFESCIENCES, WAS NOT THE SOURCE OF INFECTION. IN THIS CASE, INVESTIGATION RESULTS SUGGEST A DOG SCRATCH MAY HAVE CAUSED THE EARLY ENDOCARDITIS. THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THEREFORE, BASED ON THE FINDINGS, THIS EVENT IS NO LONGER CONSIDERED TO BE FDA REPORTABLE AND A CORRECTED REPORT IS BEING SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE, SAPIEN M3 VALVE - MODEL 9880TFX29MCLUS, IS NOT SOLD OR MARKETED IN THE US; HOWEVER, IT IS DEEMED SIMILAR TO THE SAPIEN 3 TRANSCATHETER HEART VALVE - MODEL 9600TFX29, PMA # P140031. THE PMA/510K FIELD WILL BE BLANK. 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 NON-CONFORMANCES 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 EDWARDS LIFESCIENCES, 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. THE ROOT CAUSE OF THE EARLY ENDOCARDITIS IS UNKNOWN; HOWEVER, IT MAY BE DUE TO PATIENT FACTORS AND/OR PROCEDURAL FACTORS NOT PROVIDED. 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. H3 OTHER TEXT: DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    AS REPORTED FROM A CLINICAL STUDY, APPROXIMATELY 55 DAYS POST TRANSSEPTAL TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) PROCEDURE WITH A 29 MM SAPIEN M3 VALVE, THE PATIENT WAS DIAGNOSED WITH BACTEREMIA. SUBSEQUENTLY, APPROXIMATELY 61 DAYS POST TMVR PROCEDURE, IT WAS FOUND THAT THE PATIENT HAD ENDOCARDITIS. THE SOURCE OF THE BACTEREMIA IS UNKNOWN AS NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932726 SAPIEN M3 VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9880TFX29MCLUS 00690103214291

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R