BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3071203 · Received April 22, 2013

    Report

    Report Number
    2015691-2013-19874
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE, PARAVALVULAR LEAK IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVE AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS SAPIEN RETROFLEX 3 TRANSFEMORAL DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. IN ADDITION, THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PARAVALVULAR LEAK, INCLUDING DEVICE MALPOSITIONING, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, IMPROPER VALVE SIZING, AND UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE. IN THIS CASE, PER REPORT, AFTER BEING DISCHARGED FOLLOWING THE TAVR PROCEDURE THE PATIENT UNDERWENT A PROCEDURE TO PLACE A DIALYSIS CATHETER. DURING THIS PROCEDURE, THE PATIENT ARRESTED DURING THE ADMINISTRATION OF ANESTHESIA. DURING THE SUBSEQUENT AGGRESSIVE CPR, THE SAPIEN VALVE DISLODGED AND BECAME CANTED, WHICH RESULTED IN THE PVL. 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 AT THIS TIME.

    Description of Event or Problem · 1

    PER THE EDWARDS FIELD REPRESENTATIVE, SIX DAYS AFTER HAVING A 23MM SAPIEN VALVE SUCCESSFULLY IMPLANTED 50:50 ACROSS A SEVERELY CALCIFIED NATIVE AORTIC ANNULUS, THE PATIENT RETURNED TO THE HOSPITAL FOR PLACEMENT OF A DIALYSIS CATHETER. THE PATIENT WAS NOTED TO HAVE TOLERATED THE TAVR PROCEDURE WELL AND HAD BEEN DISCHARGED FROM THE HOSPITAL PRIOR TO THE PROCEDURE TO PLACE THE DIALYSIS CATHETER. DURING THE ADMINISTRATION OF ANESTHESIA, THE PATIENT ARRESTED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. DURING CPR THE SAPIEN VALVE DISLODGED AND BECAME CANTED WITHIN THE AORTA, RESULTING IN A LARGE PARAVALVULAR LEAK (PVL). THE SAPIEN VALVE WAS EXPLANTED AND WAS REPLACED WITH A 23MM EDWARDS MAGNA EASE VALVE. THE PATIENT WAS IN A STABLE CONDITION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172516 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention