BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3122949 · Received May 21, 2013

    Report

    Report Number
    2015691-2013-20140
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 23, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. EXPLANTS AT IMPLANT ARE TYPICALLY A RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. IT WAS REPORTED THAT THIS DEVICE WAS REPLACED WITH ANOTHER PROSTHESIS, ONE SIZE SMALLER, SUGGESTING THAT THIS EVENT MAY HAVE BEEN RELATED TO A SIZING ISSUE. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. DUE TO PATIENT PRIVACY REGULATIONS, THE HEALTHCARE PROVIDER WAS NOT ABLE TO RELEASE ANY ADDITIONAL INFORMATION (E.G. OPERATIVE REPORT). THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS IMPLANTED THEN EXPLANTED DURING THE SAME PROCEDURE. THE REASON FOR EXPLANT IS UNKNOWN. ANOTHER EDWARDS VALVE WAS IMPLANTED, ONE SIZE SMALLER. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223666 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention