BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3233016 · Received July 18, 2013

    Report

    Report Number
    2015691-2013-20636
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE OP REPORT DOCUMENTS SEVERE STRUCTURAL VALVE DETERIATION (SVD) OF THE PROSTHETIC VALVE, CAUSING THE PATIENT'S STENOSIS. 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. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. NO FURTHER ACTIONS ARE POSSIBLE.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 YEARS DUE TO SEVERE AORTIC STENOSIS. PER THE OP REPORT, THE PATIENT PRESENTED WITH SEVERE STRUCTURAL VALVE DETERIORATION IN HIS BIOPROSTHETIC VALVE WITH RESULTANT AORTIC STENOSIS AND MILD AORTIC INSUFFICIENCY. THEREFORE, HE WAS REFERRED FOR REDO-AORTIC VALVE REPLACEMENT. NO FINDINGS ON THE PROSTHETIC VALVE WERE DOCUMENTED. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335741 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R