BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 22311658 · Received June 23, 2025

    Report

    Report Number
    2015691-2025-05103
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    March 4, 2025
    Report Date
    June 23, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GIUSTINO, GENNARO, ET AL. FIRST IN HUMAN PERCUTANEOUS TRANSSEPTAL RETRIEVAL OF EMBOLIZED TRANSCATHETER VALVE IN THE LEFT VENTRICLE (RETRIEVE). CARDIOVASCULAR INTERVENTIONS (2025). THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, THE ARTICLE WAS ACCEPTED FOR PUBLICATION ON MARCH 4, 2025. THEREFORE, THE SUBMISSION FOR PUBLICATION DATE WAS USED AS THE OCCURRENCE DATE. PER THE INSTRUCTIONS FOR USE (IFU), VALVE EMBOLIZATION 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 EMBOLIZATION OF THE DEVICE, 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, LOSS OF PACING CAPTURE, A NARROW SINOTUBULAR JUNCTION (IN AORTIC POSITION PROCEDURES), RAPID DEPLOYMENT, THE RELEASE OF STORED TENSION DURING DEPLOYMENT, INACCURATE MEASUREMENT OF THE LANDING ZONE, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE IFU CAUTIONS THAT INCORRECT SIZING OF THE LANDING ZONE 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 (ALL MODELS). 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 EMBOLIZATION (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. INVESTIGATION RESULTS SUGGEST/INDICATE PROCEDURAL FACTORS (LOW VALVE IMPLANTATION) 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, PER ARTICLE FIRST IN HUMAN PERCUTANEOUS TRANSSEPTAL RETRIEVAL OF EMBOLIZED TRANSCATHETER VALVE IN THE LEFT VENTRICLE 88 YEAR OLD WOMAN UNDERWENT LEFT ATRIAL VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) SUPPORTED VALVE IN VALVE WITH LEAFLET MODIFICATION OF A FAILED 26MM NON EDWARDS VALVE WITH A 20MM SAPIEN 3 RESULTING IN LEFT VENTRICULAR (LV) TRANSCATHETER HEART VALVE (THV) EMBOLIZATION WHILE ATTEMPTING A LOW IMPLANTATION. A SECOND 20MM SAPIEN 3 WAS IMPLANTED SUCCESSFULLY. ON POSTOPERATIVE DAY 1, THE EMBOLIZED THV WAS STABLE IN THE LEFT VENTRICULAR OUTFLOTRACT, CAUSING HIGH GRADIENT AND HEMOLYSIS. PERCUTANEOUS TRANSEPTAL RETRIEVAL OF THE EMBOLIZED VALVE WAS PERFORMED USING THE ONO DEVICE. THV WAS IMPLANTED IN THE INFERIOR VENA CAVA BELOW THE RENAL VEINS. THE PATIENT WAS DISCHARGED ALIVE FROM THE HOSPITAL AND REMAINS IN NYHA FUNCTIONAL CLASS I STATUS AT 30 DAYS OF FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940595 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX20A

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention