BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 6073795 · Received November 2, 2016

    Report

    Report Number
    2015691-2016-03243
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    February 10, 2009
    Report Date
    October 3, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: PRODUCT EVALUATION WAS NOT PERFORMED AS THE DEVICE REMAINS IMPLANTED. THE CLINICAL OBSERVATION WAS UNABLE TO BE CONFIRMED. ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER AORTIC VALVE REPLACEMENT (AVR) IS ASSOCIATED WITH MANY PATIENT-RELATED AND PROCEDURAL-RELATED FACTORS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER AVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENT UNDERGOING AVR AND WILL DEVELOP POST-OPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. ARRHYTHMIAS AND CONDUCTION DISTURBANCES ARE ALSO COMMON AFTER SURGICAL REPAIR OR REPLACEMENT OF THE TRICUSPID AND MITRAL VALVES DUE TO THE PROXIMITY OF THE CONDUCTION PATHWAYS. THIS ADVERSE EVENT IS NOT A MANUFACTURING RELATED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A PATIENT DEVELOPED A PERSISTENT BRADYCARDIA NODAL RHYTHM AFTER RECEIVING AN EDWARDS 29MM BIOPROSTHETIC VALVE. A PERMANENT PACEMAKER WAS IMPLANTED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722955 CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ MITRAL PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 7000TFX29MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention