BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3112502 · Received May 14, 2013

    Report

    Report Number
    2015691-2013-20075
    Event Type
    Death
    Date Received
    May 14, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED 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 HEAVILY 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. IT WAS ALSO REPORTED THAT THE PATIENT EXPIRED AT THE END OF THE PROCEDURE. THERE IS NO EVIDENCE SUGGESTING THAT THE EDWARDS DEVICE(S) CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. 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 PROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 19 YEARS DUE TO CRITICAL AORTIC STENOSIS. PER THE OP REPORT, THE PREVIOUSLY PLACED VALVE WAS HEAVILY CALCIFIED AND HAD CHANGES CONSISTENT WITH CRITICAL AORTIC STENOSIS. THE DEVICE WAS REPLACED WITH A NEW PROSTHETIC VALVE. POSTOPERATIVE TEE SHOWED A NORMALLY FUNCTIONING BIOPROSTHESIS INT HE AORTIC POSITION WITHOUT EVIDENCE OF PARAVALVULAR LEAK. INITIALLY, LEFT VENTRICULAR FUNCTION SEEMED GOOD; HOWEVER, THE PATIENT COULD NOT SUSTAIN ADEQUATE PERFUSION PRESSURE DESPITE GOING BACK ON PUMP AND RESTING FOR QUITE A WHILE AND MAXIMIZING INOTROPIC SUPPORT AND PUTTING IN AN INTRAAORTIC BALLOON PUMP. DESPITE ALL THE ABOVE EFFORTS, THE PATIENT COULD NOT DEVELOP HEMODYNAMIC STABILITY AND WAS PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212906 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| R