BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE

    MDR report key: 6546095 · Received May 4, 2017

    Report

    Report Number
    2015691-2017-01217
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    January 26, 2017
    Report Date
    April 12, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P150036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE CLINICAL OBSERVATION WAS UNABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE SERIAL NUMBER WAS NOT PROVIDED. A, FOLLOWING SURGICAL AORTIC VALVE REPLACEMENT (AVR), NEW-ONSET BUNDLE BRANCH BLOCK HAS BEEN REPORTED IN 16% TO 32% OF PATIENTS AND THE NEED FOR PERMANENT PACEMAKERS IN 3% TO 8% OF PATIENTS. THE REASON FOR POST-OPERATIVE AV BLOCK AFTER SURGICAL AVR IS RELATED TO INJURY TO THE CARDIAC CONDUCTION SYSTEM DURING SURGICAL EXCISION OF THE ADJACENT DISEASED VALVE AND ANNULAR TISSUE. THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVULAR COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE EXPLAINS THE POSSIBLE DEVELOPMENT OF CONDUCTION ABNORMALITIES FOLLOWING PROSTHETIC AORTIC VALVE PROCEDURES. ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TAVR AND AVR ARE ASSOCIATED WITH MANY PATIENT-RELATED AND PROCEDURAL-RELATED FACTORS. THE MECHANISM OF THE DEVELOPMENT OF HEART BLOCK AFTER TAVR AND SURGICAL AVR ARE WELL DOCUMENTED AND DESCRIBED IN LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING TAVR OR SURGICAL AVR AND ANOTHER 4-6% WILL DEVELOP POST OPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    A PERMANENT PACEMAKER WAS IMPLANTED THE DAY AFTER THE SURGERY (POD+1)TO TREAT THE ISSUE. THE SUBJECT DEVICE WAS IMPLANTED WITH 4 SINGLE SUTURES DUE TO A VERY BOG AND DEEPER NON-CORONARY SINUS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT A PATIENT WITH AN EDWARDS VALVE IMPLANTED IN THE AORTIC POSITION EXPERIENCED AN ARRHYTHMIA EVENT. AN AV BLOCK OCCURRED. A PERMANENT PACEMAKER WAS IMPLANTED TO TREAT THE ISSUE. AS REPORTED, THE PATIENT UNDERWENT SURGICAL PROCEDURE FOR AN AVR + CAD. SURGICAL APPROACH WAS FULL STERNOTOMY AND CABG X 2. THE SURGEON SAID THAT AFTER THE CABG, THE BYPASS FLOW WAS NOT SATISFACTORY, PATIENT BECAME ASYSTOLE AND A TEMPORARY PM WAS REQUIRED. HOWEVER, DUE TO AV BLOCK, THE PACEMAKER BECAME PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325692 EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE TISSUE, HEART-VALVE LWR EDWARDS LIFESCIENCES 8300AB27

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention