BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3131912 · Received May 29, 2013

    Report

    Report Number
    2015691-2013-20183
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 29, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THERE ARE SEVERAL POTENTIAL CAUSES FOR PROSTHETIC VALVE STENOSIS (E.G. CALCIFICATION, PANNUS GROWTH). UNFORTUNATELY, THE VALVE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE REPORTED STENOSIS. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 YEARS DUE TO AORTIC STENOSIS. PER THE OP REPORT, TRANSESOPHAGEAL ECHOCARDIOGRAM CONFIRMED MODERATE AORTIC STENOSIS, AS WELL AS SEVERE MITRAL STENOSIS. NO FINDINGS ON THE VALVE DURING EXPLANT WERE DOCUMENTED. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. BIVENTRICULAR FUNCTION WAS EXCELLENT WITH NO PARAVALVULAR LEAKS AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237399 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R