BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3033047 · Received April 3, 2013

    Report

    Report Number
    2015691-2013-19720
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 4, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED IN PATIENT; EVALUATION NOT POSSIBLE. UNFORTUNATELY, THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, EDWARDS COULD NOT ASSESS THIS VALVE TO CONFIRM THE ROOT CAUSE OF THIS EVENT. AORTIC REGURGITATION (AR) IN BIOPROSTHETIC HEART VALVES, ALSO KNOWN AS AORTIC INSUFFICIENCY, OCCURS WHEN THE VALVE DOES NOT CLOSE PROPERLY IN DIASTOLIC PHASE, WHICH RESULTS IN RETROGRADE FLOW OF BLOOD INTO THE LEFT VENTRICLE. TRIVIAL/TRACE TO MILD AMOUNTS OF AR ARE NOT UNUSUAL POST OPERATIVELY IN BIOPROSTHETIC VALVES. THIS IS USUALLY TOLERATED BY THE PATIENTS. LIKE MR, IF THE REGURGITATION WORSENS OR BECOMES SYMPTOMATIC, REOPERATION MAY BE NECESSARY. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. IN THIS CASE, THE SURGEON NOTED THAT THE REGURGITATION WAS PREDICTED SINCE THE VALVE HAD BEEN IMPLANTED FOR 14 YEARS. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION. HOWEVER, ADVANCES IN VALVE DESIGN AND BIOPROSTHETIC MATERIAL HAVE BEEN MADE WITH THE INTENTION OF REDUCING PERIVALVULAR OR CENTRAL LEAKS BY PROVIDING MORE EFFICIENT HEMODYNAMICS AND LONGER TISSUE DURABILITY.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PATIENT HAD RE-OPERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY 14 YEARS DUE TO AORTIC REGURGITATION. THE SURGEON NOTED THAT THIS WAS PREDICTED SINCE THE VALVE WAS IMPLANTED FOR 14 YEARS. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137020 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 GG6919

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R