BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA RESILIA VALVE, 29MM

    MDR report key: 18717815 · Received February 15, 2024

    Report

    Report Number
    2015691-2024-01079
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    January 24, 2024
    Report Date
    February 16, 2024
    Manufacturer
    EDWARDS LIFESICENCES
    Product Code
    NPU
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE VALVE REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER VALVE REPLACEMENT (THV) PROCEDURE. THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PVL, INCLUDING DEVICE MALPOSITION, INACCURATE MEASUREMENT OF THE LANDING ZONE, UNEVEN DISTRIBUTION OF CALCIUM ON THE LANDING ZONE, BULKY OR SEVERE CALCIFICATION, A LANDING ZONE WITH AN ELLIPTICAL SHAPE, AND VALVE UNDER OR OVERSIZING. EDWARDS EXTENSIVELY TRAINS PHYSICIANS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV (ALL MODELS). THE THV TRAINING MANUALS INSTRUCTS THE OPERATOR ON PROPER IMAGING SCREENING REQUIREMENTS, INCLUDING THE USE OF GOOD QUALITY ECHOCARDIOGRAPHY AND/OR COMPUTED TOMOGRAPHY (CT) TO APPROPRIATELY MEASURE THE LANDING ZONE, ASSESS THE CONTENT AND DISTRIBUTION OF CALCIUM, AND OTHER PATIENT ANATOMICAL FACTORS. MULTIPLE IMAGING MODALITIES SHOULD BE CONSIDERED DURING VALVE SIZE SELECTION. CONTRAINDICATIONS, IMPORTANT CONSIDERATIONS WHEN ASSESSING THE VALVE, AND CHOOSING THE PROPER THV ARE ALSO DISCUSSED. THE THV TRAINING MANUALS ALSO INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING PATIENTS SCREENING AND PROCEDURAL CONSIDERATIONS. DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES ARE ALSO INCLUDED. PER THE INSTRUCTIONS FOR USE (IFU), VALVE MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT (THV) 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, 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, INACCURATE MEASUREMENT OF THE LANDING ZONE, A LANDING ZONE WITH AN ELLIPTICAL SHAPE, AND VALVE UNDER OR OVERSIZING. ADDITIONAL RISK FACTORS IN AORTIC POSITION INCLUDE A NARROW SINOTUBULAR JUNCTION AND SEVERE SEPTAL HYPERTROPHY. THE IFU CAUTIONS THAT INCORRECT SIZING OF THE VALVE MAY LEAD TO PARAVALVULAR LEAK, MIGRATION, OR EMBOLIZATION. THE THV 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 THV (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 MALPOSITION OR EMBOLIZATION, A 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 THAT PATIENT (NO VIABLE TISSUE FOR SURGICAL BIOPROSTHESIS WITH IMPLANT VIA OPEN STERNOTOMY APPROACH) AND PROCEDURE (IMPLANTED TOO ATRIAL) FACTORS 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. 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. H3 OTHER TEXT : THE VALVE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, AFTER IMPLANT OF A 29MM SAPIEN 3 ULTRA RESILIA IN THE NATIVE MITRAL POSITION VIA OPEN PROCEDURE, THE PATIENT WAS TAKEN OFF THE HEART PUMP AND ONCE THE PATIENT WAS OFF THE PUMP, A PARAVALVULAR LEAK WAS NOTED. A 2ND SAPIEN 3 29MM ULTRA RESILIA VALVE WAS IMPLANTED VIA TRANSAPICAL APPROACH WITH GOOD RESULTS. PER REPORT, THIS PATIENT HAD NO VIABLE TISSUE TO SEW INTO FOR A SURGICAL BIOPROSTHESIS. A DECISION WAS MADE TO DIRECTLY IMPLANT A SAPIEN 3 ULTRA RESILIA VALVE IN THE NATIVE MITRAL. THE 1ST S3UR VALVE WAS IMPLANTED TOO 'ATRIAL SHALLOW'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323048 EDWARDS SAPIEN 3 ULTRA RESILIA VALVE, 29MM PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESICENCES 9755RSL29A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention