BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 4103432 · Received September 19, 2014

    Report

    Report Number
    2015691-2014-02194
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 22, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - THE REPORTED DEVICE WAS NOT RETURNED TO MANUFACTURER AS IT WAS DISCARDED. WITHOUT RECEIPT OF THE EXPLANTED DEVICE THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED. 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

    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 27MM BIOPROSTHETIC MITRAL VALVE IMPLANTED APPROXIMATELY SEVEN (7) YEARS AND FIVE (5) MONTHS WAS EXPLANTED DUE TO SEVERE MITRAL STENOSIS AND SEVERE MITRAL REGURGITATION SECONDARY TO CALCIFICATION. PATIENT IS NOTED TO BE FEMALE AND 44 YEARS OLD AT TIME OF EXPLANT AND HER MEDICAL HISTORY INCLUDES CHILDHOOD RHEUMATIC FEVER, CHRONIC ATRIAL FIBRILLATION AND HYPERTENSION. EXPLANTED VALVE WAS DISCARDED. PATIENT RECEIVED IMPLANT OF A MECHANICAL VALVE AND WAS REPORTED IN CRITICAL BUT STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584760 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R