BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3090706 · Received May 2, 2013

    Report

    Report Number
    2015691-2013-19978
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD = X-RAY. DEVICE EVALUATION SUMMARY: AS RECEIVED, LEAFLET 1 HAD 2 TEARS; ONE AT COMMISSURE 1, TEAR MEASURED APPROX 7MM, AND THE SECOND TEAR AT COMMISSURE 2 WHICH MEASURED TO APPROXIMATELY 10 MM. A HOLE WAS ALSO OBSERVED ON LEAFLET 1 NEAR THE WIREFORM, AREA APPROX 3MM X 1MM. LEAFLET 2 HAD A CUT AREA NEAR THE FREE MARGIN, AREA APPROX 3MM X 1MM. EDGES APPEARED SHARP AND CLEAN. LEAFLET 2 ALSO HAD A TEAR AT COMMISSURE 3, TEAR MEASURED APPROX 4MM. LEAFLET 3 HAD 2 TEARS, ONE TEAR AT COMMISSURE 3, TEAR MEASURED APPROX 4MM, AND ONE TEAR AT COMMISSURE 1, TEAR MEASURED APPROX 8MM. MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF LEAFLET 1 AND 2, MODERATE TO HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 3. THE FREE MARGIN OF LEAFLET 1 EXHIBITED MINIMAL TO MODERATE CALCIFICATION. THICKENED AND SWOLLEN TISSUE WAS ALSO OBSERVED ON THE FREE MARGINS OF ALL 3 LEAFLETS. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 2MM. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 2MM. HOST TISSUE WAS MODERATE TO HEAVY AT THE STENT INFLOW AND MINIMAL TO MODERATE AT THE STENT OUTFLOW.WIREFORM EXPOSED ON INFLOW ASPECT. WIREFORM WAS ALSO EXPOSED ON THE OUTFLOW AT COMMISSURES 1 AND 2. SEWING RING APPEARED CUT NEAR COMMISSURE 2. DEVICE EVALUATION CONFIRMS CALCIFIC TISSUE DEGENERATION AS THE PRIMARY CAUSE OF THE REPORTED DEGENERATION LEADING TO STENOSIS AND REGURGITATION OF THIS VALVE, IN ADDITION TO HOST TISSUE OVERGROWTH (PANNUS). 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. THERE IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT. IT IS LIKELY THAT THIS PATIENT'S HISTORY AND DISEASE STAGE MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY HOSPITAL OR STAFF MEMBER THAT AN EDWARDS AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 12 YEARS DUE TO AORTIC INSUFFICIENCY AND STENOSIS. OPERATIVE REPORT INDICATES, " THE PATIENT 12 YEARS AGO UNDERWENT AN UNCOMPLICATED AORTIC VALVE REPLACEMENT BY MYSELF. HE HAS DEVELOPED PROGRESSIVE AORTIC INSUFFICIENCY AND WAS FOUND TO HAVE 2 LEAFLETS DEGENERATED AND ALSO HAS AORTIC STENOSIS. HE COMES NOW FOR REDO STERNOTOMY AND AORTIC VALVE REPLACEMENT...[FINDINGS INDICATE] THE PROSTHETIC AORTIC VALVE WAS DEFINITELY END-OF-LIFE WITH 2 LEAFLETS OUT OF 3 DESTROYED. NO EVIDENCE OF INFECTION. THE STENTS WERE PRETTY CLOSELY ADHERENT TO THE WALL OF THE AORTA AND LIKEWISE THERE WAS HEAVY CALCIFICATION ABOUT THE AORTIC ANULUS. WE WERE ABLE TO SHARPLY RESECT THE AORTIC VALVE BIOPROSTHESIS AND REPLACE IT...[AT THE END OF PROCEDURE] THE PATIENT WAS TAKEN WITH STERILE DRESSINGS TO THE INTENSIVE CARE UNIT IN CRITICAL BUT STABLE CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191295 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R