BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM

    MDR report key: 19042680 · Received April 4, 2024

    Report

    Report Number
    2015691-2024-02565
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    March 13, 2024
    Report Date
    August 13, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECEIVED. SECTIONS: B7,G3, G6, H2.

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), VALVE THROMBOSIS IS A POTENTIAL RISK ASSOCIATED WITH THE USE OF THE TRANSCATHETER HEART VALVES (THV). 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. POTENTIAL PATIENT RISK FACTORS SUCH AS ATRIAL FIBRILLATION, SYSTEMIC DISEASE (E.G., SYSTEMIC LUPUS ERYTHEMATOSUS, INFLAMMATION, AND DAMAGE TO VARIOUS BODY TISSUES, INCLUDING JOINTS, SKIN, KIDNEYS, HEART, LUNGS, BLOOD VESSELS, AND BRAIN), THE VALVULAR DISEASE ITSELF, AND REDUCED CARDIAC EJECTION FRACTION CAN CONTRIBUTE TO INCREASED RISK OF THROMBUS THROMBOSIS. SUB OPTIMAL ANTICOAGULATION DURING THE PROCEDURE AND UNDERLYING PATIENT CONDITIONS CAN ALSO RESULT IN INCREASED THROMBOGENICITY. THESE PATIENTS ARE ANTICOAGULATED FOR THE PROCEDURE AND INTERVENTIONAL BEST PRACTICES MANDATE METICULOUS PREPARATION, ASPIRATION, AND FLUSHING OF THE DEVICES TO PREVENT AND OR REMOVE CLOTS. SHORT TERM ANTICOAGULATION THERAPY MAY ALSO BE NECESSARY AFTER VALVE REPAIR, ANTICOAGULATION IS PRESCRIBED PER INSTITUTIONAL GUIDELINES. INTRA PROCEDURAL INTRA CARDIAC THROMBUS AND POST PROCEDURE OR LATE VALVE THROMBOSIS ARE COMPLEX PROCESSES TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE WHICH ARE HIGHLY VARIABLE AMONG PATIENTS. IT IS THE NATURAL TENDENCY OF THE BODY TO FORM A CLOT ON FOREIGN OBJECTS IN THE VASCULAR SPACE AND A DEFINITIVE ROOT CAUSE CANNOT ALWAYS BE CONFIRMED. THE DEVICE TRAINING MANUALS INSTRUCT THE OPERATOR TO CONSIDER ALL PROCEDURAL AND ANATOMICAL FACTORS. EDWARDS EXTENSIVELY TRAINS PHYSICIANS BEFORE THEY ARE QUALIFIED TO USE THE DEVICE SYSTEM. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY IN CONJUNCTION WITH ECHOCARDIOGRAPHY FOR OPTIMAL VISUALIZATION DURING POSITIONING AND DEPLOYMENT AND CAUTIONS INCLUDE THE MAINTENANCE OF THE PATIENTS ANTICOAGULATION STATUS (ACT AT GREATER THAN 250 SECONDS) DURING THE PROCEDURE. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST THE CAUSE OF THE THROMBUS COULD NOT BE DETERMINED. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED BY EDWARDS LIFESCIENCES AFFILIATE IN FRANCE, ONE DAY AFTER THE IMPLANTATION OF A 23MM SAPIEN 3 ULTRA VALVE, THE PATIENT PRESENTED A 39MMHG GRADIENT BY ECHO. IT WAS CONFIRMED A VALVE THROMBOSIS BY SCANNER THE SAME DAY. AFTER THE PROCEDURE, THE PATIENT WAS TREATED WITH HEPARIN HNF. AS A CONSEQUENCE, THE PATIENT WAS NOT DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83667 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization