BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 18336004 · Received December 15, 2023

    Report

    Report Number
    2015691-2023-18411
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    January 4, 2022
    Report Date
    January 18, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED B.4, G.3, AND H.2. ADDED ADDITIONAL INFORMATION TO A.2. THIS IS ONE OF SIX MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2023-18408, 2015691-2023-00496, 2015691-2023-00497, 2015691-2023-00498, AND 2015691-2023-00499.

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2023-18408. ERLEBACH, MAGDALENA, ET AL. ''THE 10-YEAR HORIZON: SURVIVAL AND STRUCTURAL VALVE DEGENERATION IN FIRST-GENERATION TRANSCATHETER AORTIC VALVES.'' ARCHIVES OF CARDIOVASCULAR DISEASES 115.6-7 (2022): 369-376. 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), AND DEVICE DEGENERATION ARE KNOWN POTENTIAL RISKS ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. THE IFU CAUTIONS THAT ACCELERATED DETERIORATION OF THE VALVE MAY OCCUR IN PATIENTS WITH AN ALTERED CALCIUM METABOLISM. LONG-TERM DURABILITY HAS NOT BEEN ESTABLISHED FOR THE VALVE. REGULAR MEDICAL FOLLOW-UP IS ADVISED TO EVALUATE VALVE PERFORMANCE. STRUCTURAL VALVE DETERIORATION (SVD) MAY BE MANIFESTED AS STENOSIS WITH THICKENED LEAFLETS. SVD MAY BE MILD AND NOT REQUIRE ANY INTERVENTION OR IT MAY BE MODERATE TO SEVERE. IT CAN CAUSE THE HEART TO WORK HARDER TO EJECT BLOOD FROM THE VENTRICLE. DEPENDING ON THE SEVERITY IT COULD BE AN INDICATION FOR VALVE REPLACEMENT OR MEDICAL INTERVENTION. TISSUE CALCIFICATION IS A VERY COMMON FAILURE MODE. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT YET FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT-RELATED (E.G., PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. DURING THE MANUFACTURING PROCESS, ALL SAPIEN THV VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% FUNCTIONALLY TESTED FOR PROPER COAPTATION UNDER PHYSIOLOGICAL BACKPRESSURE CONDITIONS PRIOR TO RELEASE FOR DISTRIBUTION. THEREFORE, IT IS HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION CONTRIBUTED TO THE EVENT. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. DUE TO LIMITED INFORMATION, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. 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: REMAINS IMPLANTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS EUROPEAN AFFILIATE, A REVIEW OF MEDICAL ARTICLE ''THE 10-YEAR HORIZON: SURVIVAL AND STRUCTURAL VALVE DEGENERATION IN FIRST-GENERATION TRANSCATHETER AORTIC VALVES'' WAS PERFORMED. THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: ONE (1) PATIENT WITH A SAPIEN XT VALVE PRESENTED STRUCTURAL VALVE DETERIORATION LEADING TO AORTIC STENOSIS THAT REQUIRED A REINTERVENTION WITH A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929278 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Unknown Required Intervention