BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3024147 · Received March 27, 2013

    Report

    Report Number
    2015691-2013-19673
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 27, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE SOURCE OF THE REPORTED CALCIFICATION COULD NOT BE ASSESSED. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED, IT APPEARS THAT THE STENOSIS WAS LIKELY CAUSED BY THE CALCIFICATION NOTED ON THE VALVE. 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 OTHER DETAILS PROVIDED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF LEAFLETS 1 AND 2, MODERATE TO HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 3. THE FREE MARGINS OF LEAFLETS 1 AND 2 EXHIBITED HEAVY CALCIFICATION, FREE MARGIN OF LEAFLET 3 EXHIBITED MINIMAL TO MODERATE CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MODERATE TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE. HOST TISSUE WAS MODERATE TO HEAVY AT THE STENT OUTFLOW AND MINIMAL AT THE STENT INFLOW. THROMBUS WAS OBSERVED ON BOTH THE INFLOW AND OUTFLOW OF LEAFLET 3. THE X-RAY DEMONSTRATED CALCIFICATION. X-RAY. THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS AND EVALUATED. THE INITIAL REPORT OF STENOSIS CAUSED BY CALCIFICATION WAS CONFIRMED. THE HEAVY CALCIFICATION ON THE PATIENT'S PROSTHETIC VALVE LED TO STENOSIS, REQUIRING THE REDO-VALVE REPLACEMENT. THERE ARE NO CHANGES TO THE ORIGINAL CONCLUSION OF THE THIS EVENT.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 YEARS AND 9 MONTHS DUE TO SEVERE MITRAL STENOSIS AND CALCIFICATION. PER THE OP REPORT, THIS PATIENT PRESENTED WITH DYSPNEA ON EXERTION AND CLASS III CONGESTIVE HEART FAILURE AND WAS FOUND TO ON EVALUATION TO HAVE MITRAL STENOSIS WITH A GRADIENT OF 18. EJECTION FRACTION WAS PRESERVED AND CORONARIES WERE NORMAL. SHE WAS REFERRED FOR REOPERATIVE VALVE REPLACEMENT. THE OPERATIVE FINDINGS INDICATE THAT THE MITRAL VALVE WAS SEVERELY FIXED WITH CALCIFIC CHANGES. A NEW EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED AND SHOWED GOOD APPOSTION OF THE SEWING RING TO THE VALVE ANNULUS. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE SATISFACTORILY AND WAS TAKEN TO THE ICU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127337 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R