BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 3191632 · Received June 26, 2013

    Report

    Report Number
    2015691-2013-20435
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 29, 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 WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 YEARS DUE TO MITRAL STENOSIS (MS). PER THE OP REPORT, TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED SEVERE BIOPROSTHETIC MS WITH AN EF OF 40%. THE PATIENT'S MITRAL VALVE WAS REPLACED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE NEW VALVE WAS CONFIRMED TO BE IN APPROPRIATE POSITION. THE PATIENT WAS THEN WEANED FROM CARDIOPULMONARY BYPASS. POST-PROCEDURE EF OF 40% WITH TRIVIAL PARAVALVULAR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290340 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R