BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INTUITY ELITE VALVE SYSTEM

    MDR report key: 21637718 · Received March 18, 2025

    Report

    Report Number
    2015691-2025-02035
    Event Type
    Injury
    Date Received
    March 18, 2025
    Report Date
    April 22, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MEDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. ONITORED ON A THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    ADDED INFORMATION TO H6. HEART BLOCK, ALSO KNOWN AS AV BLOCK, IS WHEN THE ELECTRICAL SIGNAL THAT CONTROLS THE HEARTBEAT IS PARTIALLY OR COMPLETELY BLOCKED. THIS MAKES THE HEARTBEAT SLOWLY OR SKIP BEATS HINDERS THE ABILITY FOR THE HEART TO PUMP BLOOD EFFECTIVELY. SYMPTOMS INCLUDE DIZZINESS, SYNCOPE, TIREDNESS AND SHORTNESS OF BREATH. PACEMAKER IMPLANTATION IS A COMMON TREATMENT. THE REASON FOR POSTOPERATIVE AV BLOCK AFTER SURGICAL VALVE REPLACEMENT IS RELATED TO INJURY TO THE CARDIAC CONDUCTION SYSTEM DURING SURGICAL EXCISION OF THE ADJACENT DISEASED VALVE AND ANNULAR TISSUE. IN ADDITION, HEART BLOCK CAN RESULT FROM MECHANICAL PRESSURE FROM THE DEVICE SEWING RING AGAINST THE CONDUCTIVE SYSTEM. THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE VALVULAR COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE EXPLAINS THE POSSIBLE DEVELOPMENT OF CONDUCTION ABNORMALITIES FOLLOWING PROSTHETIC VALVE PROCEDURES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED, AS NO SERIAL/LOT NUMBER WAS PROVIDED. THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN REVIEWED, AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARD TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT AND/OR PROCEDURAL FACTORS LIKELY CAUSED OR CONTRIBUTED.

    Description of Event or Problem · 0

    ORAL PRESENTATION POSITION OF EDWARDS INTUITY ELITE VALVE SYSTEM IN TERM OF EARLY RESULTS THE 53RD JAPAN ANNUAL MEETING OF THE JAPANESE SOCIETY FOR CARDIOVASCULAR SURGERY. ON (B)(6) 2023. BACKGROUND: INVESTIGATION OF EARLY RESULTS OF AORTIC VALVE REPLACEMENT (AVR) WITH EDWARDS INTUITY ELITE VALVE SYSTEM (EIE) AND CONSIDERATION OF EIES POSITION. METHODS: ASSESSED 77 PATIENTS (77 MALES, AGES 57-89 (MEAN 76.1) WHO UNDERWENT AVR WITH EIE FROM ON (B)(6) 2019. THE INDICATION AT THE TIME OF EIE IMPLANT WAS AS FOLLOWS: 67 AORTIC STENOSIS (AS) CASES, AND 10 REDO-AVR CASES (REASONS WERE SVD 7, PROSTHETIC VALVE ENDOCARDITIS (PVE) 2, PARAVALVULAR LEAKAGE (PVL) 1) (INDICATION FOR THE INITIAL AVR WITH AN UNKNOWN VALVE WERE AS 6 AND AORTIC REGURGITATION (AR) 4). THIS INCLUDED 22 CASES OF HEMODIALYSIS AND 7 CASES WITH PREOPERATIVE (PRE-OP) CONDUCTION DISTURBANCE (5 COMPLETE RIGHT BUNDLE BRANCH BLOCK (CRBBB) CASES AND 2 COMPLETE LEFT BUNDLE BRANCH BLOCK (CLBBB) CASES). RESULTS: THE TYPES OF SURGERY WERE ISOLATED AVR 20, SIMULTANEOUS SURGERY 57 (CABG 32, ASCENDING AND/OR ARCH REPLACEMENT 10, MITRAL ANNULOPLASTY 8, MITRAL VALVULOPLASTY 2, MAZE 5, ETC.). THE BREAKDOWN OF EIE VALVE SIZES WAS 19MM IN 15 CASES, 21MM IN 25 CASES, 23MM IN 19 CASES, 25MM IN 17 CASES, AND 27MM IN 1 CASE. OPERATION TIME: 130-420 (MEAN 250) MINUTES, EXTRA CORPOREAL CIRCULATION TIME: 54-178 (MEAN 110) MINUTES, TIME OF CARDIAC ISCHEMIA: 38-122 (MEAN 84) MINUTES. OF THE 77 CASES, EXCLUDING 5 CASES WITH PRE-OP PACEMAKER (PM) IMPLANTED, 72 CASES INCLUDED 14 CASES DEVELOPED CLBBB, 2 CASES DEVELOPED COMPLETE ATRIOVENTRICULAR BLOCK (BOTH HAD PRE-OP CRBBB), AND 4 CASES RECEIVED PM IMPLANTATION. HEMODYNAMICS THE RESULTS WERE COMPARED WITH THOSE OF AVR CASES USING NON-EVERTING MATTRESS TECHNIQUE WITH MAGNA-EASE/INSPIRIS VALVES (VALVE SIZE: 19MM IN 12 CASES, 21MM IN 38 CASES, 23MM IN 26 CASES, AND 25MM IN 21 CASES) DURING THE SAME PERIOD. A COMPARISON OF MEAN PRESSURE GRADIENT ON ECHOCARDIOGRAPHY BETWEEN EIE AND MAGNA-EASE SHOWED A FAVORABLE TREND FOR 19MM EIE VALVE CASES. CT IMAGES OF THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) SHOWED THAT IN EIE CASES, THE SKIRT THAT EXPANDS INTO LVOT DOES NOT REDUCE ITS ORIGINAL ORIFICE AREA, WHEREAS IN THE MAGNA-EASE CASES, THE SEWING RING MADE THE ORIFICE AREA SMALLER THAN ITS ORIGINAL ORIFICE AREA, WHICH WAS CONSIDERED TO BE PARTICULARLY NOTICEABLE IN SMALL-SIZE VALVES. [OPERATION TIME] IN CASES WHERE SIMULTANEOUS SURGERY (WITH CABG GREATER THAN EQUAL TO X2), THE TIME OF CARDIAC ISCHEMIA WAS SIGNIFICANTLY SHORTER WITH EIE CASES THAN WITH MAGNA-EASE CASES. [CONDUCTION DISTURBANCE] A COMPARISON OF THE OCCURRENCE OF CONDUCTION DISTURBANCES IN 25 CASES PERFORMED 1 YEAR WITHIN THE INTRODUCTION OF EIE WITH 52 CASES PERFORMED THEREAFTER SHOWED THAT THE OCCURRENCE SIGNIFICANTLY DECREASED WITH EXPERIENCE. [PVL] THE GRADE OF PVL AT DISCHARGE WAS 0 IN 71 CASES AND 1 IN 6 CASES. THE 3 OF 6 CASES WITH GRADE 1 PVL IMPROVED TO GRADE 0 IN THE REMOTE PHASE, WHILE 2 CASES (BOTH HAD BICUSPID AORTIC VALVE AND REDO-AVR CASE POST AVR FOR AR) WORSENED TO GRADE 2 IN THE REMOTE PHASE. CONCLUSION: EIE HAS SHOWN FAVORABLE HEMODYNAMIC TRENDS, ESPECIALLY IN SMALL-SIZE PROSTHETIC VALVES, AND HAS ENABLED SHORTENING OF OPERATION TIME. WITH EXPERIENCE, IT WAS ABLE TO REDUCE THE OCCURRENCE OF CONDUCTION DISTURBANCE. CASES IN WHICH GRADE GREATER THAN OR EQUAL TO 2 PVL WAS OBSERVED WERE ALL CASES OTHER THAN AS CASES WITH TRICUSPID AORTIC VALVE. THE USE OF EIE IS EFFECTIVE IN IMPROVING THE HEMODYNAMICS IN AS PATIENTS WITH TRICUSPID AORTIC VALVE AND NARROW AORTIC ANNULUS, AS WELL AS SHORTENING OPERATION TIME IN SIMULTANEOUS SURGERIES. HOWEVER, CAUTION IS REQUIRED WHEN USING IN CASES OTHER THAN TRICUSPID AORTIC VALVE AS PATIENTS OR IN PATIENTS WITH PRE-OP CRBBB. WITH THE UNDERSTANDING OF THE ADVANTAGES AND DISADVANTAGES, EIE COULD BE A WELL-SUITED OPTION. THIS EVENT CAPTURES THE PACEMAKER IMPLANTED: 4 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4133 EDWARDS INTUITY ELITE VALVE SYSTEM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 8300AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R