BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1871915 · Received October 16, 2010

    Report

    Report Number
    2015691-2010-14213
    Event Type
    Death
    Date Received
    October 16, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 17, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: HEAVY CALCIFICATION IS DETECTED IN THE CUSP AREA OF LEAFLETS 1 AND 3. MODERATE CALCIFICATION IS DETECTED IN THE CUSP AREA OF LEAFLET 2. THE FREE MARGINS OF LEAFLETS 1 AND 3 EXHIBIT MODERATE TO HEAVY CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. A GAP IS NOTED AT THE COAPTATION REGION. MODERATE TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 7MM. AT THE OUTFLOW ASPECT, HOST TISSUE OVERGROWTH FUSED THE FREE MARGINS OF LEAFLET 1 AND 3 AT COMMISSURE 1 BY APPROXIMATELY 3MM. HOST TISSUE IS MINIMAL AT THE STENT INFLOW AND THE STENT OUTFLOW. SECTION OF THE SEWING RING IS CUT OFF. THE X-RAY DEMONSTRATES CALCIFICATION. TISSUE CALCIFICATION IS A CHRONIC AND USUALLY LATE EVENT FOR THE VAST MAJORITY OF BIOPROSTHETIC HEART VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. THE INCIDENCE OF TISSUE CALCIFICATION IN BIOPROSTHETIC HEART VALVES IS HIGHLY VARIABLE AMONG PATIENTS, SUGGESTING THAT BIOLOGICAL FACTORS, SUCH AS PATIENT'S AGE, DISEASE STATE, IMMUNE STATUS, AND PHARMACOLOGICAL INTERVENTION CAN PLAY IMPORTANT ROLES IN THIS PROCESS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCES.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA VOICEMAIL FROM A HEALTHCARE PROVIDER, PATIENT CAME IN FOR AN AORTIC VALVE IMPLANT DUE TO THE (B)(6) TISSUE VALVE "NOT WORKING AFTER MANY YEARS". ON 09/20/10, THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER VIA THE TELEPHONE, ON THURSDAY, (B)(6) 2010, THE SURGEON EXPLANTED (2800, 19MM) VALVE FROM PATIENT AFTER AN APPROXIMATE 111 MONTH IMPLANT DURATION. UNFORTUNATELY, THE PATIENT DID NOT SURVIVE LONG AFTER THE REDO IMPLANTATION OF A NEW VALVE. THE PATIENT EXPIRED ON (B)(6)2010. THE VALVE THAT WAS EXPLANTED IS EXTREMELY STENOSED. PER THE DISCHARGE SUMMARY RECEIVED FROM THE HOSPITAL DATED (B)(6)2010, THIS (B)(6) FEMALE WITH A HISTORY OF AORTIC VALVE REPLACEMENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINT OF ACUTE SHORTNESS OF BREATH. SHE ALSO HAD INCREASE IN HER CHRONIC LOWER EXTREMITY EDEMA. SHE WAS DIAGNOSED WITH CONGESTIVE HEART FAILURE. CARDIAC CATHETERIZATION PERFORMED REVEALED CRITICAL AORTIC STENOSIS, AS WELL AS 30% STENOSIS IN THE RIGHT RCA. AT OPERATION, THE AORTIC VALVE WAS FOUND TO BE SEVERELY CALCIFIED AND TRULY HAD AN AORTIC VALVE AREA OF 0.2 CM SQUARED. THE PATIENT DEVELOPED RIGHT VENTRICULAR HYPOKINESIS FOLLOWING THE AORTIC VALVE REPLACEMENT AND MITRAL VALVE REPAIR, SUGGESTING RIGHT CORONARY ISCHEMIA. THERE WAS A TREMENDOUS AMOUNT OF SCAR TISSUE IN THE AORTIC ROOT AND SCAR AND CALCIFICATION AROUND THE ORIFICE OF THE RIGHT CORONARY ARTERY FOLLOWING EXPLANTATION OF THE BIOPROSTHESIS. IT WAS HYPOTHESIZED THAT THE PATIENT WAS EXPERIENCING RIGHT CORONARY ISCHEMIA, THEREFORE A SAPHENOUS VEIN GRAFT WAS HARVESTED FROM THE LOWER EXTREMITY AND ANASTOMOSED END TO SIDE TO THE RIGHT CORONARY ARTERY. THIS RESULTED IN IMPROVEMENT OF THE RIGHT VENTRICULAR HYPOKINESIS. HOWEVER, THE PATIENT HAD BORDERLINE HEMODYNAMICS, DESPITE INCREASING SUPPORT WITH DEBUTAMINE, DOPAMINE, AND EPINEPHRINE. THEREFORE, AN INTRAAORTIC BALLOON PUMP WAS PLACED, WHICH INITIALLY IMPROVED THE BLOOD PRESSURE, BUT THE PATIENT HAD AN OBVIOUS RIGHT VENTRICULAR INJURY, WHICH DID NOT ALLOW FOR TRANSPORT OF BLOOD TO THE LEFT SIDE OF THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 1C0429

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death