BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 24681220 · Received March 24, 2026

    Report

    Report Number
    2015691-2026-13461
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 24, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVES ARE: P140031 - EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; P140031 - EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE; P140031 - EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE. PER THE INSTRUCTIONS FOR USE (IFU), VALVE MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO MALPOSITION, INCLUDING IMPROPER POSITIONING BEFORE DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY OR BULKY/SEVERELY CALCIFIED LEAFLETS, PRESERVED EJECTION FRACTION, SIGNIFICANT LANDING ZONE CALCIFICATION, LOSS OF PACING CAPTURE, RAPID DEPLOYMENT, THE RELEASE OF STORED TENSION DURING DEPLOYMENT, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE IFU CAUTIONS THAT INCORRECT SIZING OF THE VALVE MAY LEAD TO PARAVALVULAR LEAK, MIGRATION, OR EMBOLIZATION. THE DEVICE TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVES. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR IN THE PLACEMENT AND FIXATION OF THE DEVICE. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN PATIENTS WITH HIGH-RISK ANATOMICAL FEATURES FOR MALPOSITION (I.E., MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BALLOON VALVULOPLASTY MAY INDICATE POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED, INVESTIGATION RESULTS SUGGEST PROCEDURAL FACTORS (PUSHER WAS BEHIND THE SECOND MARKER) MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. 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. 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 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.

    Description of Event or Problem · 0

    AS REPORTED BY OUR EDWARDS LIFESCIENCES AFFILIATE IN CANADA, THE PATIENT UNDERWENT A VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) USING AN EDWARDS SAPIEN VALVE. DURING THE PROCEDURE, THE SAPIEN VALVE WAS IMPLANTED WITHIN A PRE-EXISTING NON-EDWARDS TRANSCATHETER HEART VALVE (THV). THE FIRST SAPIEN VALVE WAS SEATED LOWER THAN INTENDED, WHICH REQUIRED IMPLANTATION OF A SECOND SAPIEN VALVE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED, AND THE PATIENT REMAINED IN STABLE CONDITION. IT WAS REPORTED THAT THE VALVE WAS DEPLOYED WHILE POSITIONED BETWEEN THE MARKERS AND THAT THE PUSHER HAD BEEN RETRACTED; HOWEVER, IT WAS ALSO REPORTED THAT THE PUSHER WAS BEHIND THE SECOND MARKER. IT WAS REPORTED THAT THIS MAY HAVE RESULTED IN THE FIRST VALVE BEING POSITIONED CLOSER TO THE LEFT CORONARY CUSP SIDE AND ANCHORING WITHIN THE NON-EDWARDS VALVE ALONG THE INNER CURVATURE INSTEAD OF THE OUTER CURVATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740020 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention