BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE

    MDR report key: 6200553 · Received December 22, 2016

    Report

    Report Number
    2015691-2016-03867
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 29, 2016
    Report Date
    December 6, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P150036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE INSTRUCTIONS FOR USE (IFU) WAS REVIEWED AND NO INADEQUACIES WERE IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE IFU PROVIDES THE FOLLOWING INFORMATION: THE FINAL DECISION TO USE THE EDWARDS INTUITY ELITE VALVE SYSTEM SHOULD BE MADE AFTER THE NATIVE AORTIC VALVE IS EXCISED AND THE ANNULUS IS DEBRIDED, OR DECALCIFIED. AN ASSESSMENT OF THE POTENTIAL INTERACTION BETWEEN THE EDWARDS INTUITY ELITE VALVE SYSTEM AND SURROUNDING CARDIAC STRUCTURES ¿ SUCH AS, THE AORTIC ANNULUS, ANTERIOR LEAFLET OF THE MITRAL VALVE, AND CORONARY OSTIA ¿ SHOULD BE CONDUCTED TO INFORM APPROPRIATE USE OF THE DEVICE. FAILURE TO CONSIDER THESE FACTORS MAY LEAD TO IMPLANT FAILURE AND CLINICAL COMPLICATIONS INCLUDING, BUT NOT LIMITED TO, PARAVALVULAR LEAK, INTERFERENCE WITH MITRAL VALVE FUNCTION, AND SEVERE CONDUCTION DISTURBANCES REQUIRING PERMANENT PACEMAKER IMPLANTATION. CAUTION: OVER-INFLATION MAY CAUSE EXCESSIVE FRAME EXPANSION AND MAY RESULT IN ANNULAR DAMAGE, CONDUCTION INTERFERENCE/ARRHYTHMIA, OR SUBANNULAR TISSUE DAMAGE. USE OF THE EDWARDS INTUITY ELITE VALVE SYSTEM MAY BE ASSOCIATED WITH NEW OR WORSENED CONDUCTION SYSTEM DISTURBANCES, WHICH MAY REQUIRE A PERMANENT CARDIAC PACEMAKER IMPLANT. " THE IFU PRESENTS THE NUMBER OF NEW OR WORSENED CARDIAC CONDUCTION DISTURBANCES OR ARRHYTHMIAS DETERMINED TO BE DEVICE-RELATED BY THE INVESTIGATIONAL SITE THROUGH THE TRANSFORM TRIAL. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS THROUGH THE USE OF EDWARDS QUALITY SYSTEMS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A PATIENT EXPERIENCED A HEART BLOCK EVENT SOON AFTER THE IMPLANTATION OF AN EDWARDS VALVE. PER MEDICAL RECORDS, THERE WERE NO ISSUES DURING SIZING, DEPLOYMENT OR SEATING OF VALVE. INTRA-OPERATIVE ECHO SHOWED THE VALVE WAS WORKING WELL. THERE WERE NO INTRAOPERATIVE COMPLICATIONS AND THE PATIENT WAS WEANED FROM BYPASS EASILY WITH AN SPONTANEOUS RECOVERY OF THE SINUS RHYTHM. AS PER DISCHARGE SUMMARY, THE PATIENT WAS DOING WELL AFTER SURGERY AND WAS WEANED FROM PHARMACOLOGICAL SUPPORT AND EXTUBATION 8 HOURS AFTER SURGERY. SOON AFTER, IT WAS REPORTED THE OCCURRENCE OF TRANSIENT SIGNALS OF AVB THAT REQUIRED DDD STIMULATION WITH SUBSEQUENT RECOVERY OF SINUS RHYTHM. SUBSEQUENT APPEARANCE OF A PERSISTENT 3RD DEGREE AVB LEAD TO THE IMPLANT OF A PACEMAKER AT POD+6. THERE WAS AN EPISODE OF PAROXYSMAL AF IN THIS POST-OPERATIVE PERIOD WITH RESTORATION OF SINUS RHYTHM AT POD+7. THE AORTIC VALVE REMAINS IMPLANTED. PATIENT WAS DISCHARGED AT POD+13 IN GOOD CONDITION. BASED ON THE CONCOMITANT DISEASES IN THE DISCHARGE SUMMARY AND THE EKG BASAL, THERE IS NO EVIDENCE OF THE PATIENT HAVING A HISTORY OF CARDIAC DISTURBANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850419 EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE TISSUE, HEART-VALVE LWR EDWARDS LIFESCIENCES 8300AB25

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention