BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4222162 · Received November 3, 2014

    Report

    Report Number
    2015691-2014-02601
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, DEVICE MIGRATION REQUIRING INTERVENTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH TRANSCATHETER AORTIC 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, AND INCORRECT BIOPROSTHETIC VALVE SIZING, 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 AORTIC VALVE AND ROOT, 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. THE SAPIEN XT VALVE WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. VISUAL EVALUATION REVEALED NO ABNORMALITIES ON THE FRAME, SKIRT OR LEAFLETS. SINCE THE VALVE HAS BEEN ALREADY BEEN MANIPULATED (CRIMPED, DEPLOYED AND EXPLANTED), NO FURTHER RELEVANT EVALUATION COULD BE PERFORMED. IN ADDITION, THE CAUSE OF THE EVENT WAS PROVIDED BY THE REPORTER. IN THIS CASE, PER REPORT, THE VALVE MIGRATION WAS ATTRIBUTED TO POST PROCEDURE VIOLENT EPISODES OF VOMITING IN COMBINATION WITH THE LACK OF LEAFLET/NATIVE ANNULAR CALCIFICATION. 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

    ONE DAY POST SUCCESSFUL TRANSFEMORAL TAVR PROCEDURE, TTE REVEALED THE SAPIEN XT VALVE HAD MIGRATED INTO THE LVOT. THE SAPIEN XT VALVE WAS EXPLANTED AND WAS REPLACED WITH A SURGICAL VALVE. INITIALLY, THE VALVE HAD BEEN DEPLOYED IN A 50:50 POSITION. THE POST DEPLOYMENT ECHO SHOWED NO CENTRAL AI OR PVL. ONE DAY POST IMPLANT, THE PATIENT WAS SITTING UP IN BED FOR TTE. ECHO SHOWED THV VALVE HAD MIGRATED INTO THE LVOT BUT HAD NOT EMBOLIZED. THE THV VALVE WAS STILL FUNCTIONING FINE; HOWEVER, THERE WAS A CONCERN FOR EMBOLIZATION. THE THV VALVE WAS ALSO IMPEDING ON THE ANTERIOR MITRAL LEAFLET. THE PATIENT'S NATIVE LEAFLETS WERE WORKING AGAIN THOUGH MODERATE CENTRAL AI WAS NOTED. THE SAPIEN XT WAS EXPLANTED AND WAS REPLACED WITH A SURGICAL VALVE. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION POST PROCEDURE. THE PATIENT¿S NATIVE ANNULUS MEASURED 23MM BY TEE AND HAD AN AREA OF 450-460MM² BY CT. THE NATIVE ANNULUS AND ROOT HAD NO CALCIFICATION, AND PER THE SURGEON, ONLY MINIMAL CALCIFICATION WAS NOTED ON THE DISTAL TIPS OF THE LEAFLETS WHICH ALSO APPEARED TO BE THICK AND RUBBERY. THE VALVE MIGRATION WAS ATTRIBUTED TO POST PROCEDURE VIOLENT EPISODES OF VOMITING IN COMBINATION WITH THE LACK OF LEAFLET/NATIVE ANNULAR CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702756 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention