BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3102796 · Received May 9, 2013

    Report

    Report Number
    2015691-2013-20038
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TAVR PROCEDURE. THE EDWARDS THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER SAPIEN VALVE PERFORMANCE WILL BE IMPAIRED. IN THIS CASE, THE CAUSE OF THE CAI APPEARS TO BE OVERHANGING NATIVE LEAFLETS. IT WAS NOTED AFTER THE FACT THAT THE BAV PERFORMED A WEEK PRIOR CAUSE THE NATIVE LEAFLETS TO BECOME DETACHED AND FLAILING. THIS LED TO THE NATIVE LEAFLETS OVERHANGING THE FIRST IMPLANTED SAPIEN VALVE. THIS WAS RECTIFIED WITH THE DEPLOYMENT OF A SECOND VALVE SLIGHTLY MORE AORTIC. 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; THEREFORE NO FURTHER ACTIONS ARE REQUIRED. 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.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), POST DEPLOYMENT OF A SAPIEN VALVE, THERE WAS CENTRAL AORTIC INSUFFICIENCY (CAI) REQUIRING PLACEMENT OF A SECOND VALVE. THE PATIENT HAD A BAV WITH A 25MM BALLOON THE WEEK PRIOR AND WAS FAIRLY UNSTABLE DUE TO MODERATE TO SEVERE CAI. THE THV PROCEDURE WAS MOVED UP BECAUSE OF THE CAI. THE SAPIEN VALVE WAS PLACED 60:40 VENTRICULAR AS INTENDED, BUT IT WAS NOTED AFTER DEPLOYMENT TOO BE LOW TO COVER WHAT APPEARED FROM TEE TO BE TWO VERY LONG, DETACHED FLAILING NATIVE LEAFLETS. THE TEAM FIGURED OUT WHAT WAS HAPPENING WHEN THEY LOOKED AT THE TEE AND SAW THE NATIVE LEAFLETS PROTRUDING AND EVEN BEING DRAWN INTO THE SAPIEN VALVE, CAUSING CAI. IT WAS DECIDED TO PLACE A SECOND VALVE A BIT HIGHER THAN THE FIRST. THE SECOND VALVE WAS LANDED 50-50 ON THE FIRST SAPIEN FRAME. WHEN THE TEAM PULLED THE WIRE BACK THERE WAS TRACE PVL AND NO AI. PT IS DOING WELL AND STABLE. PER REPORT, THE ROOT CAUSE OF THE CAI WAS THE TWO VERY LONG, DETACHED FLAILING NATIVE LEAFLETS PROTRUDING AND COMING OVER TOP IF THE FIRST SAPIEN, CAUSING CAI. IT WAS ALSO BELIEVED THAT THE LEAFLETS WERE FLAILING FROM THE BAV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204148 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention