BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 6340653 · Received February 17, 2017

    Report

    Report Number
    2015691-2017-00409
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    November 11, 2016
    Report Date
    January 23, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, VALVE MIGRATION REQUIRING INTERVENTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH TRANSCATHETER AORTIC VALVE REPLACEMENT. STENT VALVES ARE SUBJECTED TO ANTEGRADE EJECTION FORCES DURING SYSTOLE. LESS-THAN-SEVERE AND NON-UNIFORMLY DISTRIBUTED CALCIFICATION OF THE NATIVE LEAFLETS, INCORRECT BIOPROSTHETIC VALVE SIZING, AND INCOMPLETE FRAME EXPANSION, CAN CONTRIBUTE TO VALVE MIGRATION. THE EDWARDS S3 TRANSCATHETER HEART VALVE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS. DEPLOYMENT OF THE S3 VALVE IN A NATIVE MITRAL VALVE IS NOT INDICATED PER THE LABELING; THEREFORE THE LABELING (IFUS AND EW TRAINING MANUALS) DO NOT INSTRUCT THE OPERATOR HOW TO POSITION THE S3 VALVE IN THIS SCENARIO. IN THIS CASE, THE CAUSE OF THE REPORTED MIGRATION OF THE S3 VALVE IMPLANTED IN THE NATIVE MITRAL VALVE CANNOT BE DETERMINED. HOWEVER, THERE WAS NO ALLEGATION OR INDICATION OF A DEVICE MALFUNCTION. 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. REFERENCE: BAUERNSCHMITT R, BAUER S, LIEWALD C, EMINI R, OECHSNER W, BEER M, SODIAN R, LIEBOLD A. FIRST SUCCESSFUL TRANSCATHETER DOUBLE VALVE REPLACEMENT FROM A TRANSAPICAL ACCESS AND NINE-MONTH FOLLOW-UP. EUROINTERVENTION: JOURNAL OF EUROPCR IN COLLABORATION WITH THE WORKING GROUP ON INTERVENTIONAL CARDIOLOGY OF THE EUROPEAN SOCIETY OF CARDIOLOGY. 2017 JAN 20;12(13):1645.

    Description of Event or Problem · 1

    A CASE REPORT PUBLISHED BY THE "EUROINTERVENTION: JOURNAL OF EUROPCR IN COLLABORATION WITH THE WORKING GROUP ON INTERVENTIONAL CARDIOLOGY OF THE EUROPEAN SOCIETY OF CARDIOLOGY" DESCRIBED THE LATE MIGRATION OF A SAPIEN 3 VALVE THAT HAD BEEN IMPLANTED IN MITRAL POSITION DURING A SUCCESSFUL DOUBLE VALVE REPLACEMENT INTO NATIVE VALVES VIA TRANSAPICAL APPROACH AT A GERMAN HOSPITAL. A (B)(6), HIGHLY SYMPTOMATIC FEMALE PATIENT CONSIDERED INOPERABLE DUE TO SEVERE CALCIFICATION OF THE MITRAL ANNULUS AND COMORBIDITIES WAS SCHEDULED FOR TRANSCATHETER DOUBLE VALVE REPLACEMENT BY THE LOCAL HEART TEAM. PREOPERATIVE PLANNING WAS CARRIED OUT BY MULTI-PLANAR RECONSTRUCTION FROM CARDIAC CT. THROUGH A TRANSAPICAL ACCESS, THE MITRAL VALVE WAS REPLACED FIRST BY AN INVERTED 29 MM EDWARDS SAPIEN 3 PROSTHESIS, THEN THE AORTIC VALVE BY A 23 MM SAPIEN 3, BOTH DURING RAPID PACING. BOTH PROSTHESES REVEALED EXCELLENT FUNCTION IN ANGIOGRAPHY AND ECHOCARDIOGRAPHY. THE PATIENT WAS EXTUBATED EARLY AFTER SURGERY AND TRANSFERRED TO THE NORMAL WARD THE FOLLOWING DAY. AFTER FIVE MONTHS, THE PATIENT AGAIN EXHIBITED SIGNS OF CARDIAC FAILURE, THE REASON BEING MIGRATION OF THE MITRAL PROSTHESIS TOWARDS THE LEFT VENTRICLE OUTFLOW TRACK (LVOT). TEE REVEALED A GRADIENT OF 63 MMHG ACROSS THE LVOT, PARAVALVULAR REGURGITATION BEING ONLY TRACE. THE MITRAL PROSTHESIS SHOWED A MEAN GRADIENT OF 4 MMHG AND MILD REGURGITATION. AS THE OVERALL CONDITION OF THE PATIENT HAD MEANWHILE MARKEDLY IMPROVED, REPLACEMENT OF THE MITRAL PROSTHESIS BY OPEN HEART SURGERY WAS POSSIBLE. THE EXPLANTED PROSTHESIS APPEARED TO BE SLIGHTLY IMPRESSED AT THE REGION TOUCHING THE AORTIC PROSTHESIS, WHILE THE LEAFLETS DID NOT REVEAL ANY SIGNS OF DEGENERATION. THE PATIENT RECOVERED WELL FROM THE SURGERY. THE AUTHORS CONCLUDED THAT THE REASON FOR THE LATE EMBOLIZATION OF THE MITRAL PROS­THESIS IS DIFFICULT TO SPECULATE ON. CARDIOPULMONARY RESUSCITATION (CPR) WAS NEVER NECESSARY IN THIS PATIENT. ¿LOOSENING¿¿ OF THE MITRAL PROSTHESIS BY IMPLANTATION OF THE AORTIC PROSTHESIS SEEMS UNLIKELY, BECAUSE THE MITRAL PROSTHESIS STAYED IN PLACE FOR SEVERAL MONTHS. THE CASE DESCRIBED REVEALS THE FEASIBILITY AND SAFETY OF DOU­BLE VALVE REPLACEMENT INTO NATIVE VALVES FROM A SINGLE TRANSAPICAL ACCESS IN SELECTED PATIENTS AT HIGH OR EXTREME RISK FOR CONVENTIONAL SURGERY. THE KEY TO SUCCESS IS THOROUGH PREOPERATIVE ANALYSIS BASED ON CT, NOT ONLY FOR SIZING, BUT ALSO TO ALLOW ESTIMATION OF THE INTERFERENCE OF BOTH PROSTHESES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120891 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention