BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3864102 · Received June 10, 2014

    Report

    Report Number
    2015691-2014-01336
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    August 22, 2004
    Report Date
    May 12, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER, WITHOUT RECEIPT OF THE REPORTED DEVICE THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE INVESTIGATED OR DETERMINED. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS. ADDITIONAL INFORMATION WILL BE REPORTED IF RECEIVED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION OF A MITRAL BIOPROSTHETIC VALVE IMPLANTED IN 1999 AND THEN EXPLANTED IN 2004 DUE TO SEVERE CALCIFICATION. PATIENT RECEIVED REPLACEMENT DEVICE. PATIENT IS FEMALE AND (B)(6) AT TIME OF IMPLANT. THERE ARE NO ADVERSE EVENTS REPORTED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338376 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| L| R