BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 12131948 · Received July 7, 2021

    Report

    Report Number
    2015691-2021-03936
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    January 13, 2021
    Report Date
    August 13, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR CORRECTION AND ADDITIONAL INFORMATION BASE ON THE DEVICE EVALUATION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN UPDATED: CORRECTED H.6 COMPONENT CODES. THE SAPIEN 3 XT VALVE WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. WITHOUT THE DEVICE RETURNED FOR EVALUATION, VISUAL INSPECTION, FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS WERE UNABLE TO BE COMPLETED. NO IMAGERY WAS PROVIDED FOR REVIEW. THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. IN ADDITION, THE EVENT DOES NOT ALLEGE A LABELING ISSUE OR DEVICE RELATED INFECTION; THEREFORE NO DHR IS REQUIRED. A REVIEW OF THE LOT HISTORY WAS NOT PERFORMED. A RISK ASSESSMENT WAS PERFORMED ON THE REPORTED EVENT AND REVEAL THE FOLLOWING APPLICABLE ITEMS IN THE RISK MANAGEMENT WORKSHEET AS A POTENTIAL CAUSE THAT MAY LEAD TO REDUCED IMPLANT LONGEVITY. NO EVIDENCE OF A PRODUCT NONCONFORMANCE OR LABELING/IFU INADEQUACIES WERE IDENTIFIED IN EVALUATION. THE RISK OF VALVE DEGENERATION HAS BEEN REDUCED AS LOW AS POSSIBLE THROUGH DESIGN AND MANUFACTURING PROCESSES. EDWARDS HAS PROVIDED GUIDELINES AND INSTRUCTIONS TO THE PHYSICIANS IN THE IFU AND TRAINING MATERIALS/REFRESHER TRAINING REGARDING REGULAR MEDICAL FOLLOW-UP TO EVALUATE VALVE PERFORMANCE. USERS ARE INFORMED OF THE RESIDUAL RISKS ASSOCIATED WITH USE OF THE VALVE THROUGH THE POTENTIAL ADVERSE EVENTS SECTION IN THE INSTRUCTIONS FOR USE (IFU) AND/OR DEVICE TRAINING MATERIALS. THE BENEFITS OF THE SYSTEM OUTWEIGH THE RISKS ASSOCIATED WITH VALVE DEGENERATION. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION WAS PERFORMED, AND THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. DEVICE DEGENERATION IS A KNOWN POTENTIAL RISK ASSOCIATED WITH THE TAVR PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT. STRUCTURAL VALVE DETERIORATION (SVD) MAY BE MANIFESTED AS STENOSIS WITH THICKENED LEAFLETS. SVD REFERS TO CHANGES INTRINSIC TO THE VALVE, AND CAN INCLUDE FAILURE MODES SUCH AS WEAR, CALCIFICATION, LEAFLET TEAR, STENT CREEP, LEAFLET DISRUPTION, OR LEAFLET RETRACTION. 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 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. IN THIS CASE, COMPLAINT WAS CONFIRMED BY MEDICAL RECORD. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE FOR THE VALVE DEGENERATION APPROXIMATELY 7 YEARS, 10 MONTHS POST VALVE IMPLANT COULD NOT BE DETERMINED, BUT MAY BE RELATED TO THE PATIENT'S CO-MORBIDITIES AND/OR PROGRESSION OF THE PRE-EXISTING VALVULAR DISEASE PROCESS. 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. NO IFU/LABELING/TRAINING MANUAL INADEQUACIES WERE IDENTIFIED. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTION NOR PRODUCT RISK ASSESSMENT IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AS REPORTED BY CLINICAL SAFETY, APPROXIMATELY 7 YEARS, 10 MONTHS POST-IMPLANTATION OF 23 MM SAPIEN XT VALVE IN THE AORTIC POSITION, PATIENT PRESENTED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) EXACERBATION AND SHOWS WORSENING AORTIC STENOSIS (AS). THE ECHO REVEALED WORSENING AS WITH MEAN GRADIENT OF 44 MG AND AORTIC VALVE AREA (AVA) OF 0.4 CM2 AND A HEART CATH CONFIRM SEVERE AS. AFTER CONSULTATION, THE PATIENT WAS DEEMED 'HIGH RISK' AND A RECOMMENDATION FOR A VALVE IN VALVE (VIV) PROCEDURE. THE PATIENT WAS DEEMED STABLE ENOUGH TO BE DISCHARGED AND CONTINUE EVALUATION AS AN OUTPATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024693 SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention