BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3801151 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01077
    Event Type
    Death
    Date Received
    May 8, 2014
    Date of Event
    July 8, 2010
    Report Date
    April 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURE NARRATIVE THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC AORTIC VALVE EXHIBITED SEVERE REGURGITATION AFTER AN IMPLANT DURATION OF ONE (1) MONTH. INFORMATION OBTAINED THROUGH INVESTIGATION REVEALED THIS 61 YEAR OLD FEMALE PATIENT HAD A LONG HISTORY OF HEART DISEASE INCLUDING MITRAL VALVE REPLACEMENT AND TRICUSPID VALVE REPLACEMENT. THIS PATIENT EXPIRED WITH THE DEVICE IMPLANTED APPROXIMATELY TWO MONTHS POST-AVR. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278939 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death