BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 19426553 · Received May 30, 2024

    Report

    Report Number
    2015691-2024-04020
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    January 1, 2012
    Report Date
    June 17, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2021-04017. 2015691-2021-04018. 2015691-2021-04019. 2015691-2021-04020. 2015691-2021-04021. 2015691-2021-04022. 2015691-2021-04023. 2015691-2021-04024. 2015691-2021-04025. 2015691-2021-04026. 2015691-2021-04027.

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF ELEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS BETWEEN JANUARY 2012 AND JUNE 2021. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01 JANUARY 2012) WAS USED AS THE OCCURRENCE DATE.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: P110021 EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; P140031 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; P140031 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM REFERENCE ARTICLE OKUNO, TAISHI, ET AL. 5 YEAR OUTCOMES WITH SELFEXPANDING VS BALLOON EXPANDABLE TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH SMALL ANNULI. CARDIOVASCULAR INTERVENTIONS 16.4 (2023): 429440.PER THE INSTRUCTIONS FOR USE (IFU), VALVE MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIALADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT (THV) PROCEDURE. THERE AREMULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TOMALPOSITION, INCLUDING IMPROPER POSITIONING BEFORE DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POORCOAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY ORBULKY SEVERELY CALCIFIED LEAFLETS, PRESERVED EJECTION FRACTION, SIGNIFICANT LANDING ZONE CALCIFICATION,LOSS OF PACING CAPTURE, RAPID DEPLOYMENT, THE RELEASE OF STORED TENSION DURING DEPLOYMENT, ANDMOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE IFU CAUTIONS THAT INCORRECT SIZING OF THEVALVE MAY LEAD TO PARAVALVULAR LEAK, MIGRATION, OR EMBOLIZATION.THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THEVALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINEDBY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV (ALL MODELS). TRAINING INCLUDESPATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE SPECIFICTRAINING MANUALS, AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICEAT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR IN THE PLACEMENT AND FIXATION OF THEDEVICE. 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 INDICATEPOTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT.IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THISADVERSE EVENT. INVESTIGATION RESULTS SUGGEST, BASED ON THE LIMITED INFORMATION FROM THE ARTICLE, THE CAUSE COULD NOT BE DETERMINED. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WASPERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVEPROCEDURE, 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 IDENTIFIEDWITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS CONDITIONS FOR THE SUCCESSFUL USEOF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROLLIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED ASPART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE ORPREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN SWITZERLAND, THROUGH REVIEW OF MEDICAL ARTICLE 5 YEAR OUTCOMES WITH SELF EXPANDING VS BALLOON EXPANDABLE TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH SMALL ANNULI, CORRESPONDING AUTHOR THOMAS PILGRIM, THE FOLLOWING EVENT(S) WAS/WERE IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE. ALL PATIENTS UNDERGOING TAVR AT (B)(6) HOSPITAL. THE PRESENT ANALYSIS INCLUDED CONSECUTIVE PATIENTS WITH AN AORTIC VALVE ANNULUS AREA LESS THAN 430 MM2 WHO UNDERWENT TRANSFEMORAL TAVR WITH EITHER A MEDTRONIC SELF EXPANDING (SUPRA ANNULAR) THV OR AN EDWARDS BALLOON EXPANDABLE (INTRA ANNULAR) THV BETWEEN (B)(6) 2021. THERE WERE 4 PATIENTS WITH AN UNKNOWN SAPIEN VALVE HAD A VALVE DISLOCATION EMBOLIZATION DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178020 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 NA Unknown Required Intervention