BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3230505 · Received July 16, 2013

    Report

    Report Number
    2015691-2013-20624
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 7, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. STRUCTURAL VALVE DETERIORATION 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 WAS A TORN RIGHT CORONARY CUSP REPORTED, WHICH WAS CAUSING THE PATIENT'S LEAK. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED. 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 11 YEARS DUE TO PROSTHETIC AORTIC VALVE INSUFFICIENCY WITH POSSIBLE PERIVALVULAR LEAK (PVL). PER THE OP REPORT, EF WAS 35%. DURING EXPLANTATION OF THE AORTIC VALVE, IT DID NOT APPEAR TO HAVE A PVL. THERE WAS A LOT OF CALCIUM BUT NO PVL. THE CUSP OF THE RIGHT/LEFT AREA, WHICH WOULD BE THE RIGHT CORONARY CUSP, WAS TORN AND WAS THE CAUSE OF THE SEVERE LEAKING. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. TEE REVEALED THE NEW VALVE SEATING NICELY. PATIENT WAS WEANED OF CARDIOPULMONARY BYPASS SATISFACTORILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328143 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 HL0312

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R