BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3150743 · Received June 6, 2013

    Report

    Report Number
    2015691-2013-20268
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 9, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, ALL 3 LEAFLETS HAD CUT SECTIONS REMOVED. CUT SECTIONS WERE NOT RETURNED WITH THE VALVE. HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF ALL THREE LEAFLETS. THE FREE MARGINS OF LEAFLET 1 AND 2 EXHIBITED MODERATE CALCIFICATION, FREE MARGIN OF LEAFLET 3 EXHIBITED MINIMAL CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 2 MM. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 5 MM. HOST TISSUE WAS MODERATE AT THE STENT INFLOW AND MINIMAL AT THE STENT OUTFLOW. NO VISIBLE DAMAGE TO WIREFORM OBSERVED ON X-RAY; X-RAY DEMONSTRATED CALCIFICATION. THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS, WHICH CONFIRMED THE REPORTED EVENT. THERE WAS CALCIFICATION OBSERVED ON THE PROSTHETIC VALVE, CAUSING THE PATIENT'S STENOSIS. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 15 YEARS, 8 MONTHS DUE TO PROSTHETIC VALVE AORTIC STENOSIS. PER THE OP REPORT, THERE WAS ALSO MODERATE CALCIFIC DISEASE OF THE ASCENDING AORTA. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. POSTOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED NO PARAVALVULAR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251173 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R