BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3140805 · Received May 31, 2013

    Report

    Report Number
    2015691-2013-20222
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    February 28, 2013
    Report Date
    May 3, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE REPORTED LEAFLET PROLAPSE COULD NOT BE CONFIRMED. 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. IF THE REGURGITATION WORSENS OR BECOMES SYMPTOMATIC, REOPERATION MAY BE NECESSARY. 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 PERIVALVULAR OR CENTRAL LEAKS BY PROVIDING MORE EFFICIENT HEMODYNAMICS AND LONGER TISSUE DURABILITY. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 10 YEARS, 5 MONTHS DUE TO AORTIC INSUFFICIENCY (AI) SECONDARY TO PROSTHETIC DYSFUNCTION. PER THE OP REPORT, THIS PATIENT UNDERWENT CORONARY BYPASS GRAFTING AND AORTIC VALVE REPLACEMENT (AVR) IN 2002. HE NOW PRESENTED WITH AI. IT WAS ALSO NOTED THAT HE HAD PULMONARY HYPERTENSION WITH SIGNIFICANT TRICUSPID REGURGITATION AS WELL AS SIGNIFICANT MITRAL REGURGITATION. IT WAS FELT HE SHOULD UNDERGO REDO-AVR AND POSSIBLE MITRAL REPAIR AND TRICUSPID REPAIR. LV FUNCTION WAS PRESERVED. DURING EXPLANTATION OF THE AORTIC VALVE, THE NONCORONARY LEAFLET WAS DETACHED AT BOTH COMMISSURES, CAUSING THIS LEAFLET TO PROLAPSE. ALL ANNULAR SUTURES WERE REMOVED AND THE VALVE WAS REMOVED. VERY LITTLE DEBRIDEMENT WAS NECESSARY. A NEW EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED. THE PATIENT WAS WEANED UNEVENTFULLY FROM CARDIOPULMONARY BYPASS. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241274 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 2C0528

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R