BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE

    MDR report key: 6490935 · Received April 13, 2017

    Report

    Report Number
    2015691-2017-00994
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    March 10, 2017
    Report Date
    March 22, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P150036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE CLINICAL OBSERVATION WAS UNABLE TO BE CONFIRMED. 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. 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 RECEIVED A PERMANENT PACEMAKER AFTER RECEIVING AN EDWARDS BIOPROSTHETIC VALVE. SURGEON REPORTED THAT THIS WAS HIS THIRD CASE OF PERMANENT PACEMAKER WITH THIS TYPE OF VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272069 EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE TISSUE, HEART-VALVE LWR EDWARDS LIFESCIENCES 8300AB23

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention