BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 4132514 · Received October 1, 2014

    Report

    Report Number
    2015691-2014-02290
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 2, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD = DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT THE RETURN OF THE DEVICE OR ADDITIONAL INFORMATION, EDWARDS IS UNABLE TO DRAW ANY CONCLUSIONS AS TO THE REASON FOR EXPLANT OR ROOT CAUSE. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THIS BIOPROSTHETIC MITRAL VALVE WAS DISCARDED DUE TO MITRAL ENDOCARDITIS, WITH PRESENCE OF A PARAVALVULAR LEAK (PVL) AND RESPIRATORY FAILURE. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM BIOPROSTHETIC MITRAL VALVE. HEART FUNCTION WAS REPORTED TO BE EXCELLENT AT CONCLUSION OF THE OPERATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT." THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, A 25MM BIOPROSTHETIC MITRAL VALVE, IMPLANTED APPROXIMATELY FIVE (5) YEARS AND SEVEN (7) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER 25MM MITRAL VALVE. ATTEMPTS TO RETRIEVE DETAILS ON THE EVENT AND PATIENT HAVE BEEN MADE. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. SHOULD NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611948 CARPENTIER-EDWARDS PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX25

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention