BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3163589 · Received June 11, 2013

    Report

    Report Number
    2015691-2013-20319
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    April 30, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 2, MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF LEAFLETS 1 AND 3. THE FREE MARGIN OF LEAFLET 1 EXHIBITED MINIMAL CALCIFICATION. MODERATE TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 5 MM. HOST TISSUE WAS HEAVY AT THE STENT INFLOW. THE X-RAY DEMONSTRATED CALCIFICATION, AND BENT COMMISSURE 3 WIREFORM. X-RAY. THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS, WHICH CONFIRMED THE INITIAL REPORT OF AORTIC STENOSIS FROM A CALCIFIED PROSTHETIC VALVE. THERE IS NO CHANGE IN THE ORIGINAL CONCLUSION OF THIS CASE. NO FURTHER ACTIONS ARE BEING TAKEN.

    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. 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 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

    IN THIS CASE, IT WAS REPORTED PROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROX. 8 YEARS, 5 MONTHS DUE TO AORTIC STENOSIS. CARDIAC CATHETERIZATION SHOWED NORMAL CORONARIES. DURING EXPLANTATION, THE VALVE WAS NOTED TO BE SEVERELY STENOTIC. THE LEFT CUSP WAS THE MOST CALCIFIED. THE RIGHT CORONARY ARTERY WAS LOW-LYING AND DUE TO CONCERN, A CORONARY BYPASS GRAFT SURGERY WAS DONE TO THE RIGHT CORONARY ARTERY. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264117 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R