BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS THV VALVE UNKNOWN

    MDR report key: 12562319 · Received October 1, 2021

    Report

    Report Number
    2015691-2021-05458
    Event Type
    Death
    Date Received
    October 1, 2021
    Date of Event
    April 13, 2021
    Report Date
    October 1, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: URENA, MARINA, ET AL. 'CAUSES AND PREDICTORS OF MORTALITY AFTER TRANSCATHETER MITRAL VALVE IMPLANTATION IN PATIENTS WITH SEVERE MITRAL ANNULUS CALCIFICATION.' CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2021). THIS IS ONE OF SEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2021-05450, 2015691-2021-05451, 2015691-2021-05452, 2015691-2021-05453, 2015691-2021-05454, AND 2015691-2021-05456. THE IMPLANTED VALVE MODEL AND SIZE IS UNKNOWN. POSSIBLE VALVES USED: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE - PMA P130009 OR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE - PMA P140031. PER THE INSTRUCTIONS FOR USE (IFU), VALVE MIGRATION REQUIRING INTERVENTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH TRANSCATHETER VALVE REPLACEMENT. ACCORDING TO LITERATURE REVIEW, VALVE MIGRATION RESULTS WHEN FORCES ACTING ON THE TRANSCATHETER HEART VALVE (THV) OVERCOME THE STRENGTH OF ATTACHMENT OF THE VALVE TO THE AORTIC WALL. STENT VALVES ARE SUBJECTED TO ANTEGRADE EJECTION FORCES DURING SYSTOLE. LESS-THAN-SEVERE AND NON-UNIFORMLY DISTRIBUTED CALCIFICATION OF THE NATIVE LEAFLETS, INCORRECT BIOPROSTHETIC VALVE SIZING, AND INCOMPLETE FRAME EXPANSION, CAN CONTRIBUTE TO VALVE MIGRATION. ADDITIONALLY, RESIDUAL OVERHANGING LEAFLETS CAN EXERT DOWNWARDS FORCE DURING DIASTOLE, CAUSING MIGRATION OF THE THV TOWARDS THE LEFT VENTRICLE. THE EDWARDS THV PATIENT SCREENING MANUAL ADVISES THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE VALVE, TAKING INTO CONSIDERATION THE DEGREE AND DISTRIBUTION OF NATIVE LEAFLET CALCIFICATION. THE PROCEDURAL DIDACTIC INSTRUCTS 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 TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT SIZING, ALIGNMENT AND POSITIONING OF THE DEVICE ARE EMPHASIZED AS KEY FACTORS TO THE PLACEMENT AND FIXATION OF THE DEVICE. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION PROVIDED, THE CAUSE OF THE VALVE MIGRATION IS UNKNOWN BUT MAY BE RELATED TO THE MECHANISMS ABOVE. 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 ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THROUGH REVIEW OF THE EUROPEAN ARTICLE: 'CAUSES AND PREDICTORS OF MORTALITY AFTER TRANSCATHETER MITRAL VALVE IMPLANTATION IN PATIENTS WITH SEVERE MITRAL ANNULUS CALCIFICATION', ONE PATIENT WHO RECEIVED EITHER A SAPIEN XT OR SAPIEN 3 IN THEIR NATIVE MITRAL VALVE DIED DUE TO MIGRATION OF THE THV REQUIRING EMERGENT SURGICAL VALVE REPLACEMENT WITH UNFAVORABLE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462641 EDWARDS THV VALVE UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES EDWARDS THV VALVE UNKNOWN NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R