BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2171926 · Received July 22, 2011

    Report

    Report Number
    2015691-2011-15905
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    April 25, 2011
    Report Date
    June 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. 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.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED APPROXIMATELY HALF OF THE SEWING RING IS CUT OFF, MOST LIKELY AT EXPLANT. THE VALVE EXHIBITS HEAVY CALCIFICATION IN THE CUSP AREA OF ALL THREE LEAFLETS, MODERATE IN THE FREE MARGIN OF LEAFLETS 1. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE, AT BOTH ASPECTS, AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 6MM AT THE INFLOW ASPECT AND 4MM AT THE OUTFLOW ASPECT. HOST TISSUE IS HEAVY AT THE STENT INFLOW AND MODERATE TO HEAVY AT THE STENT OUTFLOW. THE X-RAY DEMONSTRATES CALCIFICATION. THE RETURNED DEVICE WAS EXAMINED VISUALLY AND WITH A LIGHT MICROSCOPE AND DIGITAL MICROSCOPE. THE DEVICE EVALUATION WAS COMPLETED ON (B)(4) 2011. THE EVALUATION RESULTS CONFIRM THE REPORTED EVENT.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6-1/2 YEARS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT DEVICE WAS EXPLANTED DUE TO SEVERE MITRAL STENOSIS WITH PROSTHETIC VALVE DEGENERATION. ACCORDING TO THE OPERATIVE REPORT, "THERE WAS A MODERATE AMOUNT OF ADHESION IN THE MEDIASTINUM. THE AORTA DID HAVE SOME CALCIFICATION IN THE ARCH, BUT [THE SURGEON] IDENTIFIED A NICE CROSS CLAMP CANNULATION SITE IN THE ASCENDING AORTA. THE MITRAL VALVE WAS HEAVILY CALCIFIED AND STIFF. IT WAS REMOVED." THE VALVE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. ADDITIONALLY, THE HEALTH-CARE PROVIDER HAS INDICATED THAT THE REASON FOR EXPLANT WAS NOT RELATED TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX 4F0916

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R