BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 20797339 · Received November 27, 2024

    Report

    Report Number
    2015691-2024-09021
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    October 29, 2024
    Report Date
    November 27, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    UDI-DI
    00690103192087
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), STRUCTURAL VALVE DETERIORATION (WEAR, FRACTURE, CALCIFICATION, LEAFLET TEAR/TEARING FROM THE STENT POSTS, LEAFLET RETRACTION, SUTURE LINE DISRUPTION OF COMPONENTS OF A PROSTHETIC VALVE, THICKENING, STENOSIS), IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PER A TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO SUBSEQUENT ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESIS FROM CALCIFYING. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THIS PRODUCT PROBLEM. HOWEVER, PATIENT FACTORS MIGHT HAVE CONTRIBUTED TO THE EVENT, INCLUDING THE PATIENT'S ADVANCED AGE OF 80 YEARS AND HISTORY OF HYPERLIPIDEMIA. 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. THE DEVICE WAS USED IN OFF-LABEL IMPLANTATION IN THE MITRAL POSITION. AS THERE ARE NO SPECIFIC IFU OR TRAINING MATERIALS RELATED TO MITRAL PROCEDURES, THE AVAILABLE TRAINING MATERIALS WERE REVIEWED ONLY FOR INFORMATION POTENTIALLY RELEVANT TO THE DEVICE USE.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 7 YEARS AND 11 MONTHS POST TRANSAPICAL TMVR (TRANSCATHETER MITRAL VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN XT VALVE IN A PRE-EXISTING 27MM NON-EDWARDS PROSTHETIC VALVE, THE PATIENT WAS READMITTED DUE TO HEART FAILURE. IT WAS DISCOVERED THAT THE SAPIEN XT VALVE FAILED DUE TO STENOSIS CAUSED BY CALCIFICATION, WITH THE MEAN GRADIENT MEASURING 17MMHG. THE PATIENT UNDERWENT A SUCCESSFUL VALVE IN VALVE PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA WITH +2CC NOMINAL VOLUME AND NO COMPLICATIONS. PER REPORT, THE MEAN GRADIENT WAS 5MMHG AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832066 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9300TFX26A 00690103192087

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention