BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARSD SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 6492365 · Received April 13, 2017

    Report

    Report Number
    2015691-2017-01002
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    August 1, 2016
    Report Date
    March 20, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. BIBLIOGRAPHY M. MANGIONE, FERNANDA MD, TANNAS JATENE, MD, ALEXANDRA GONÇALVES, MD, PHD, MMSC, GREGORY A. FISHBEIN, MD, RICHARD N. MITCHELL, MD, PHD, MARC P. PELLETIER, MD,C TSUYOSHI KANEKO, MD, PINAK B. SHAH, MD, CHARLES B. NYMAN, MBBCH, DOUGLAS SHOOK, MD,RON BLANKSTEIN, MD, ROBERT F. PADERA, MD, PHD, AND DEEPAK L. BHATT, MD, MPH. ¿LEAFLET THROMBOSIS IN SURGICALLY EXPLANTED OR POST-MORTEM TAVR VALVES¿, JACC: CARDIOVASCULAR IMAGING 10, NO. 1 (2017): 82-85, HTTP://DX.DOI.ORG/10.1016/J.JCMG.2016.11.009.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL CASE INFORMATION WERE MADE, HOWEVER, THE INFORMATION WAS NOT FORTHCOMING. PER THE INSTRUCTIONS FOR USE (IFU), VALVE THROMBOSIS IS A POTENTIAL RISK ASSOCIATED WITH THE USE OF THE TRANSCATHETER HEART VALVE (THV). PER THE INSTRUCTIONS FOR USE (IFU), THROMBOSIS IS A RARE AND WELL-RECOGNIZED COMPLICATION ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES. VALVE THROMBOSIS IS THE FORMATION OF SIGNIFICANT BLOOD CLOTS FORMING ON THE VALVE. THESE CLOTS COULD SIGNIFICANTLY IMPACT THE FUNCTIONALITY OF THE VALVE RESULTING IN HEART FAILURE OR THROMBOEMBOLISM. ANTICOAGULATION THERAPY MUST BE EVALUATED PATIENT BY PATIENT. THE CAUSE FOR VALVE THROMBOSIS IS THOUGHT TO RESULT FROM AN INTERACTION BETWEEN COMPONENTS OF BLOOD AND THE PROSTHESIS OR TURBULENT BLOOD FLOW IN AND AROUND THE PROSTHESIS. SEVERAL FACTORS CAN CAUSE DEVELOPMENT OF THROMBOSIS, INCLUDING: INADEQUATE ANTICOAGULANT THERAPY AFTER VALVE IMPLANT, ATRIAL FIBRILLATION, MEDICATIONS, CANCEROUS TUMORS, SYSTEMIC DISEASES (E.G, SYSTEMIC LUPUS ERYTHEMATOSUS, INFLAMMATION AND DAMAGE TO VARIOUS BODY TISSUES, INCLUDING JOINTS, SKIN, KIDNEYS, HEART, LUNGS, BLOOD VESSELS, AND BRAIN), AND REDUCED CARDIAC PUMPING (LOW EJECTION FRACTION). THROMBOSIS HAS AN EXTREMELY LOW INCIDENCE RATE IN BIOPROSTHETIC HEART VALVES. THROMBOSIS IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. SINCE THE MECHANISM OF THROMBOTIC DEPOSITION ON BIOPROSTHETIC HEART VALVES IS NOT FULLY UNDERSTOOD, THE CAUSE CANNOT ALWAYS BE CONFIRMED. IN THIS CASE, THE CAUSE OF THE VALVE THROMBOSIS IS UNKNOWN; HOWEVER, IT IS PERCEIVED TO HAVE BEEN CAUSED BY LOW PLACEMENT AND INCOMPLETE EXPANSION CAUSING THROMBUS & DEFORMATION OF THE LEAFLETS. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED THROUGH A JOURNAL ARTICLE, SIX MONTHS POST A VALVE IN VALVE (SAPIEN VALVE IN BIOPROSTHETIC SURGICAL VALVE) TAVR PROCEDURE, THE PATIENT DEVELOPED STENOSIS AND UNDERWENT A SUCCESSFUL SURGICAL AORTIC VALVE REPLACEMENT. AN (B)(6) MAN, WHO PREVIOUSLY UNDERWENT SURGICAL AORTIC VALVE REPLACEMENT, DEVELOPED VERY RAPID STENOSIS OF THE BIOPROSTHETIC VALVE 2 YEARS AFTER THE SURGERY. HE UNDERWENT A SUCCESSFUL TAVR, BUT AFTER 6 MONTHS, HIS NEW VALVE ALSO DEVELOPED STENOSIS. TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED THE TRANSCATHETER VALVE WITH DIFFUSE THICKENING INSIDE THE BIOPROSTHETIC SURGICAL VALVE. NO THROMBUS WAS SEEN. THE MEAN PRESSURE GRADIENT WAS 56 MMHG. THE PATIENT HAD BEEN CHRONICALLY TREATED WITH ASPIRIN AND CLOPIDOGREL. HE UNDERWENT A SUCCESSFUL SURGICAL AORTIC VALVE REPLACEMENT. POST-EXPLANTATION ASSESSMENT OF THE VALVES SHOWED A MUCH CALCIFIED SURGICAL VALVE. THE EDWARDS SAPIEN VALVE HAD A LOW POSITION OF IMPLANTATION AND INCOMPLETE EXPANSION CAUSING DEFORMATION OF THE LEAFLETS. THERE WAS THROMBUS IN THE OUTFLOW OF ALL 3 CUSPS RESULTING IN RESTRICTION OF MOTION AND SUBSEQUENT STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271097 EDWARSD SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention