BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3854561 · Received June 6, 2014

    Report

    Report Number
    2015691-2014-01320
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    September 22, 2005
    Report Date
    May 8, 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

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

    Description of Event or Problem · 1

    EDWARDS LEARNED OF A MITRAL BIOPROSTHETIC VALVE THAT WAS EXPLANTED 15 YEARS AFTER IMPLANT DUE TO SEVERE CALCIFICATION. PATIENT IS FEMALE AND WAS (B)(6) OLD AT TIME OF IMPLANT. THERE ARE NO ADVERSE PATIENT EFFECTS REPORTED POST EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332485 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R