BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3233758 · Received July 18, 2013

    Report

    Report Number
    2015691-2013-20637
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE SOURCE OF THE REPORTED CALCIFICATION COULD NOT BE ASSESSED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED, IT APPEARS THAT THE PATIENT'S STENOSIS WAS LIKELY CAUSED BY THE CALCIFIED VALVE. CALCIFICATION PLAYS A MAJOR ROLE IN THE FAILURE OF BIOPROSTHETIC HEART VALVES. CALCIFICATION OF VALVES OCCURS AS A PROGRESSIVE, TIME-DEPENDENT PROCESS. TISSUE VALVE CALCIFICATION IS INITIATED PRIMARILY WITHIN RESIDUAL CELLS THAT HAVE BEEN DEVITALIZED, USUALLY BY GLUTARALDEHYDE PRETREATMENT. THE PROCESS OF CALCIFICATION INVOLVES THE REACTION OF CALCIUM-CONTAINING EXTRACELLULAR FLUID WITH MEMBRANE-ASSOCIATED PHOSPHORUS, CAUSING CALCIFICATION OF THE CELLS. INITIAL CALCIFICATION DEPOSITS EVENTUALLY ENLARGE AND GROW INTO A MASS, WHICH STIFFEN AND WEAKEN THE TISSUE AND THEREBY CAUSE THE PROSTHESIS TO MALFUNCTION. THE MINERALIZATION OF A BIOMATERIAL IS GENERALLY ENHANCED AT THE SITES OF INTENSE MECHANICAL DEFORMATIONS GENERATED BY MOTION, SUCH AS THE POINTS OF FLEXION IN HEART VALVES. ULTIMATELY, THE RESULT OF CALCIFICATION IS VALVE FAILURE DUE TO TEARING OR STENOSIS. CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE¿S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS¿ TISSUE VALVES DUE TO ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF ALL THREE LEAFLETS. THE FREE MARGINS OF LEAFLETS 1 AND 2 EXHIBITED MINIMAL CALCIFICATION. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE. HOST TISSUE WAS HEAVY AT THE STENT INFLOW AND MODERATE AT THE STENT OUTFLOW. THE X-RAY DEMONSTRATED CALCIFICATION. CALCIFICATION AND HOST TISSUE RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. THE EXPLANTED VALVE WAS RETURNED TO EDWARDS FOR ANALYSIS, WHICH CONFIRMED THE REPORT OF CALCIFICATION LEADING TO STENOSIS. THERE IS NO CHANGE IN THE ORIGINAL CONCLUSION OF THIS CASE.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 YEARS DUE TO SEVERE PROSTHETIC AORTIC STENOSIS WITH CALCIFICATION. PER THE OP REPORT, HE HAS DEVELOPED WORSENING DYSPNEA AND OCCASIONAL CHEST HEAVINESS WITH EXERTION. CORONARY CATHETERIZATION DEMONSTRATED NORMAL CORONARIES; HOWEVER, IT DID DEMONSTRATE A MEAN TRANSAORTIC VALVE PRESSURE OF 48 RNMHG AND THAT THE AORTIC VALVE AREA WAS 0.852 CM SQ. FOR THESE REASONS, HE WAS BROUGHT FORWARD FOR OPERATIVE INTERVENTION. EXPLANTING THE VALVE WAS A LITTLE BIT RIGOROUS IN THAT IT WAS VERY CLOSE TO THE MEMBRANOUS SEPTUM, AND IT APPEARS THAT IT HAD BEEN SUTURED TO THE VERY TOP OF THE ANTERIOR LEAFLET OF THE MITRAL VALVE, THUS EXCISION OF THE VALVE ESSENTIALLY DETACHED THE MIDDLE 2/3 OF THE ANTERIOR LEAFLET MITRAL VALVE FROM ITS NORMAL AORTOMITRAL CURTAIN. THIS WAS REPAIRED. THE VALVE STITCHES WERE PLACED THROUGH THE ANTERIOR PORTION OF THE EDGE OF THE MITRAL VALVE AND THEN PASSED BACK THROUGH THE AORTIC ROOT. A 25 MM MAGNA EASE VALVE WAS IMPLANTED WITHOUT DIFFICULTY. THE PATIENT WEANED OFF BYPASS WITHOUT ISSUE. POSTOP ECHOCARDIOGRAM DEMONSTRATED A WELL-SEATED AORTIC PROSTHESIS AND IT APPEARED TO OPEN WELL. THE GRADIENT WAS NORMAL. NO OPERATIVE COMPLICATIONS REPORTED. PER THE PATHOLOGY REPORT, THE EXPLANTED VALVE DEMONSTRATED DEGENERATIVE CHANGES WITH CALCIFICATION; 2/3 OF THE LEAFLETS SHOWED MARKEDLY DECREASED MOBILITY DUE TO CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333753 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 4L1750

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R