BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3852330 · Received June 5, 2014

    Report

    Report Number
    2015691-2014-01309
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 8, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO STRUCTURAL VALVE DETERIORATION (SVD). SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. THE OPERATIVE REPORT DOCUMENTS LAYERED TISSUE WITHIN TWO (2) LEAFLETS OF THE VALVE. THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A BIOPROSTHETIC AORTIC VALVE, IMPLANTED APPROXIMATELY TEN (10) YEARS AND FOUR (4) MONTHS, WAS EXPLANTED DUE TO STRUCTURAL VALVE DETERIORATION. THE OPERATIVE REPORT INDICATES THE PATIENT EXPERIENCED AORTIC STENOSIS. DURING EXPLANTATION, THERE WAS SOME DECREASED LEAFLET MOBILITY AND LAYERED TISSUE WITHIN TWO (2) LEAFLETS OF THE VALVE. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328752 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R