BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3852434 · Received June 5, 2014

    Report

    Report Number
    2015691-2014-01312
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE IT REMAINS IMPLANTED. THE VALVE-IN-VALVE PROCEDURE HAS NOT BEEN CONFIRMED AS HAVING OCCURRED. THERE IS NO SERIAL NUMBER OR IMPLANT DATE OF THE DEVICE; THEREFORE, WE ARE UNABLE TO PERFORM THE DEVICE HISTORY RECORD (DHR) REVIEW. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO IDENTIFY THE DEVICE OR THE PATIENT. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. REPLACEMENT OF A BIOPROSTHETIC VALVE OVER TIME CAN OCCUR DUE TO REGURGITATION, STRUCTURAL VALVE DETERIORATION (SVD) (FROM STENOSIS - CALCIFICATION OR HOST TISSUE OVERGROWTH), DEHISCENCE, FIBROSIS OR NON-CALCIFIC DEGENERATION. IN THIS CASE, THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED TO EDWARDS FOR ANALYSIS. BASED ON THE AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM THE CLINICAL STATEMENTS IF NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EDWARDS WAS INFORMED OF A FAILED 23MM AORTIC VALVE DUE TO AORTIC INSUFFICIENCY THAT WILL BE REPLACED IN A VALVE-IN-VALVE PROCEDURE. THE 23MM AORTIC VALVE HAS BEEN IMPLANTED FOR APPROXIMATELY FOURTEEN (14) YEARS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328778 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R