BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3163617 · Received June 11, 2013

    Report

    Report Number
    2015691-2013-20322
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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 MARGIN OF LEAFLET 3 EXHIBITED MINIMAL CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE. HOST TISSUE WAS HEAVY AT THE STENT INFLOW AND MINIMAL AT THE STENT OUTFLOW. LEAFLET 3 HAD A TEAR AT COMMISSURE 3. LEAFLET 2 HAD A TEAR ACROSS THE CUSP OF LEAFLET 2. CALCIFICATION WAS ALSO VISIBLE AT THE REGIONS OF THE TEARS. THE X-RAY ALSO DEMONSTRATED CALCIFICATION. ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS, WHICH CONFIRMED THE REPORTED STENOSIS. HEAVY CALCIFICATION WAS DEMONSTRATED ON THE VALVE, EXPLAINING 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

    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 VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 YEARS, 9 MONTHS DUE TO AORTIC PROSTHETIC VALVE STENOSIS. PATIENT ALSO HAD A RIGHT CORONARY ARTERY BYPASS GRAFT, WHICH HAD A OSTIAL STENOSIS ABOUT 60% TO 70%. LEFT VENTRICLE WAS ABOUT 45% TO 50%. GRADIENT ACROSS THE PROSTHETIC AORTIC VALVE WAS MORE THAN 60 MM. AORTOTOMY WAS PERFORMED THROUGH THE SAME PREVIOUS INCISION AND LOT OF CALCIFIC ATHEROMAS WERE ENDARTERECTOMIZED AND THEN THE OLD PROSTHETIC VALVE WHICH WAS COMPLETELY STENOTIC SHARP DISSECTION WAS USED TO EXCISE THE VALVE. THOROUGH IRRIGATION WAS DONE MULTIPLE TIMES. PREVIOUS SURGEON HAD PLACED MULTIPLE PLEDGETS AND AS MANY PLEDGETS WERE REMOVED AS POSSIBLE. A NEW 21 MM EDWARDS BIOPROSTHETIC VALVE WAS THEN IMPLANTED. NO OPERATIVE COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264194 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R