BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 3233788 · Received July 18, 2013

    Report

    Report Number
    2015691-2013-20638
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 21, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE SEVERAL POTENTIAL CAUSES FOR PROSTHETIC VALVE STENOSIS (E.G. CALCIFICATION, PANNUS GROWTH). UNFORTUNATELY, THE VALVE WAS NOT EXPLANTED FROM THE PATIENT; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE INVESTIGATED. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE REPORTED STENOSIS. NO FURTHER ACTIONS ARE POSSIBLE.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PATIENT UNDERWENT VALVE-IN-VALVE (VIV) PROCEDURE IN AN EXISTING EDWARDS PROSTHETIC MITRAL VALVE, AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 YEARS DUE TO MITRAL STENOSIS (MS). PER THE OP REPORT, TEE SHOWED SEVERE BIOPROSTHETIC MS WITH AN EF OF 40%. A 26 MM EDWARDS SAPIEN TRANSCATHETER HEART VALVE WAS USED TO REPLACE THE BIOPROSTHETIC MITRAL VALVE. TEE EVALUATION REVEALED EXCELLENT VALVE POSITION AND FUNCTION WITH NO PERIVALVULAR LEAK. THERE WAS NO MS OR MITRAL REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333801 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R