BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3210877 · Received July 8, 2013

    Report

    Report Number
    2015691-2013-20552
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTION FOR USE (IFU), VALVE STENOSIS IS A POTENTIAL RISK ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PER THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), VALVE STENOSIS CAN RESULT FROM A NUMBER OF FACTORS, INCLUDING PANNUS, CALCIFICATION, SUPPORT STRUCTURE DEFORMATION (OUT-OF-ROUND CONFIGURATION), TRAUMA (CARDIO-PULMONARY RESUSCITATION, BLUNT CHEST TRAUMA), ENDOCARDITIS, PROSTHETIC VALVE THROMBOSIS, AND NATIVE LEAFLET PROLAPSE IMPEDING PROSTHETIC LEAFLET MOTION. ALTHOUGH THE CAUSE OF THE VALVE STENOSIS IN THIS CASE CANNOT BE CONFIRMED, THERE WAS NO MENTION OF PANNUS, THROMBUS OR ENDOCARDITIS IN THE ECHO REPORT. IT IS POSSIBLE THAT THE VALVE STENOSIS WAS THE RESULT OF CALCIFICATION. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. IN THIS CASE, THE PATIENT HAS A HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE, CAROTID DISEASE AND PVD WITH A PREVIOUS RENAL STENT. 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

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, FIVE YEARS AFTER THE IMPLANTATION OF A 23MM SAPIEN VALVE VIA A CLINICAL TRIAL, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CONGESTIVE HEART FAILURE (CHF) AND SHORTNESS OF BREATH. PER THE ECHO REPORT, THERE WAS PROBABLY MODERATE AORTIC REGURGITATION (AR) AND SEVERELY DECREASED AORTIC VALVE EXCURSION. THE PEAK GRADIENT ACROSS THE SAPIEN VALVE WAS 82MMHG. THE MEAN GRADIENT WAS 51MMHG. THE DIMENSIONLESS INDEX WAS 0.23, WHICH WAS DESCRIBED AS CONSISTENT WITH CLOSE TO SEVERE VALVULAR STENOSIS. THE PATIENT IS SCHEDULED TO HAVE A SECOND SAPIEN VALVE IMPLANTED WITHIN THE FIRST. PER THE CLINICAL TRIAL DATABASE, THE SAPIEN VALVE WAS IMPLANTED IN THE CORRECT POSITION WITH TRACE PARAVALVULAR LEAK (PVL) POST PROCEDURE. DURING THE PATIENT¿S ONE YEAR FOLLOW-UP VISIT IN (B)(6) 2009, AN ECHO REPORT NOTED A PEAK GRADIENT OF 53MMHG AND A MEAN GRADIENT OF 30MMHG. MILD AORTIC REGURGITATION WAS NOTED. NO ACTION WAS TAKEN AT THAT TIME TO TREAT THE AR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310131 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 1748819

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention