BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 6089357 · Received November 9, 2016

    Report

    Report Number
    2015691-2016-03311
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO A MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. 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. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. 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 LEAKS BY PROVIDING MORE EFFICIENT HEMODYNAMICS AND LONGER TISSUE DURABILITY. BASED ON THE INFORMATION RECEIVED THE CLINICAL OBSERVATION WAS CONFIRMED. THE CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT FACTORS LIKELY CONTRIBUTED TO THE EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS WAS NOTIFIED THAT A 25MM AORTIC PERICARDIAL VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 12 YEARS, NINE MONTHS, DUE TO DEGENERATED PROSTHETIC VALVE, SEVERE AORTIC REGURGITATION, AND MILD STENOSIS. A 26MM TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED INSIDE THE FAILING 25MM VALVE. PATIENT WAS REPORTED TO BE STABLE AND TRANSFERRED TO PACU. THE PATIENT WAS REPORTED AS WELL RECOVERED AND DISCHARGED ON POST OPERATIVE DAY TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740533 CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R