BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 5354316 · Received January 8, 2016

    Report

    Report Number
    2015691-2016-00076
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    December 16, 2015
    Report Date
    December 16, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS. DEPLOYMENT OF THE SAPIEN VALVE IN A PREVIOUSLY IMPLANTED PULMONIC SURGICAL VALVE IS NOT INDICATED PER THE LABELING; THEREFORE THE LABELING (IFUS AND EW TRAINING MANUALS) DO NOT INSTRUCT THE OPERATOR HOW TO POSITION THE SAPIEN VALVE IN THIS SCENARIO. IT IS NORMAL TO HAVE A SMALL GRADIENT ACROSS A PROSTHETIC VALVE AFTER IMPLANT. IF ELEVATED, IT MAY INDICATE OBSTRUCTED FLOW ACROSS THE VALVE. AN INCREASE IN GRADIENTS MAY RESULT FROM PATIENT FACTORS SUCH AS HYPERTROPHIC CARDIOMYOPATHY (HCM) OR SUB-VALVULAR AORTIC STENOSIS. ADDITIONALLY, AN INCREASE IN GRADIENTS CAN INDICATE THAT A LEAFLET IS NOT FUNCTIONING OPTIMALLY DUE TO CALCIFICATION OR EARLY THROMBUS FORMATION. IN THE INSTANCE OF A BIOPROSTHETIC VALVE IN VALVE IMPLANT AN INCREASED GRADIENT CAN BE A RESULT OF INTRAVALVULAR REGURGITATION AND IS NOT A RESULT OF A VALVE LEAFLET MALFUNCTION. IF MILD, THESE PATIENTS WILL NOT REQUIRE INTERVENTION AND WILL BE FOLLOWED WITH SERIAL ECHOCARDIOGRAPHY. IF SIGNIFICANT AND RESULTS IN SYMPTOMS, IT MAY REQUIRE INTERVENTION. IN THIS CASE, THE CAUSE OF THE INCREASE IN THE PATIENT¿S GRADIENTS 9 MONTHS POST TAVR CANNOT BE CONFIRMED. IT IS POSSIBLE, THAT THE PATIENT¿S CO-MORBIDITIES MIGHT HAVE CONTRIBUTED TO THE EVENT. THE PATIENT WAS PLACED ON A COUMADIN TREATMENT WHICH HELPED TO DECREASE HER GRADIENT. 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

    AS REPORTED BY OUR AFFILIATES IN FRANCE, THREE YEARS POST SAPIEN VALVE PLACEMENT IN A SURGICAL PULMONIC VALVE, THERE WAS INCREASED GRADIENT AND A LEAK OBSERVED. PULMONARY HOMOGRAPH ROSS INTERVENTION WAS PREVIOUSLY PERFORMED. NINE YEARS LATER, A MALFUNCTION OF THE HOMOGRAPH WAS FOUND AS THE PATIENT WAS SYMPTOMATIC WITH HIGH PRESSURE IN THE RIGHT VENTRICLE (60MMHG). LESS THAN A YEAR AFTER THE MALFUNCTION WAS FOUND, A SAPIEN VALVE WAS IMPLANTED INSIDE THE HOMOGRAFT WITH GOOD RESULTS. THREE YEARS POST SAPIEN VALVE IMPLANT, THERE WAS A VALVE DYSFUNCTION WITH A GRADIENT OF 63MMHG AND AN "IMPORTANT LEAK" INTO THE RIGHT VENTRICLE. EF LEFT VENTRICLE WAS 64%. LESS THAN A YEAR LATER, A VALVULOPLASTY WITH A NON-EDWARD'S BALLOON WAS PERFORMED. THE CONDUIT MEASUREMENT WAS 24.5MM. PHYSICIANS DECIDED TO IMPLANT A SAPIEN XT 26MM WITH VERY GOOD RESULTS AND NO LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12773 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention