BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 4251454 · Received November 14, 2014

    Report

    Report Number
    2015691-2014-02703
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL EVENT INFORMATION AND EXPLANTED DEVICES HAVE BEEN UNSUCCESSFUL. WITHOUT RETURN OF THE DEVICES OR ADDITIONAL INFORMATION, THE REPORTED EXPLANTS CANNOT BE INVESTIGATED AND A ROOT CAUSE CANNOT BE DETERMINED. 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. ADDITIONAL INFORMATION WILL BE REPORTED IF RECEIVED. THIS REPORT COVERS THE MITRAL VALVE, THE REPORT FOR THE AORTIC VALVE WAS FILED UNDER: 2015691-2014-02702.

    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, IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THE VALVES 21MM IN AORTIC POSITION AND A 27MM IN MITRAL POSITION WERE EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 YEARS. THE REASON FOR EXPLANT IS UNKNOWN. THE EXPLANTED DEVICES WERE REPLACED WITH A 21MM BIOPROSTHESIS IN AORTIC POSITION AND ANOTHER BIOPROSTHESIS IN MITRAL POSITION. NO COMPLICATIONS WERE REPORTED. THIS REPORT IS FOR THE DEVICE IN THE MITRAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736588 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R