BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3288158 · Received August 14, 2013

    Report

    Report Number
    2015691-2013-20814
    Event Type
    Death
    Date Received
    August 14, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) VEGETATIONS AND PANNUS GROWTH. ENDOCARDITIS IS AN INFLAMMATION OF THE INSIDE LINING OF THE HEART CHAMBERS AND HEART VALVES. ENDOCARDITIS IS USUALLY THE RESULT OF A BLOOD INFECTION AS BACTERIA OR OTHER INFECTIOUS SUBSTANCES ENTER THE BLOODSTREAM AND TRAVEL TO THE HEART, WHERE THEY CAN SETTLE ON HEART VALVES. ENDOCARDITIS CAN POTENTIALLY LEAD TO DISORDERS SUCH AS SEVERE VALVULAR INSUFFICIENCY AND REGURGITATION. PATIENT RISK FACTORS FOR DEVELOPING ENDOCARDITIS INCLUDE INTRAVENOUS DRUG USE, CENTRAL VENOUS ACCESS LINES, PRIOR VALVE SURGERY, RECENT DENTAL SURGERY, RHEUMATIC FEVER, AND WEAKENED VALVES. EXISTING HEART DISEASE AND ABNORMALITIES INCREASE THE LIKELIHOOD OF DEVELOPING ENDOCARDITIS. ENDOCARDITIS IS TYPICALLY CLASSIFIED AS EITHER INFECTIVE OR NON-INFECTIVE, DEPENDING ON WHETHER A MICROORGANISM IS THE SOURCE OF THE INFLAMMATION OR NOT. ENDOCARDITIS IS OFTEN ASSOCIATED WITH NOSOCOMIAL (I.E. HOSPITAL-ACQUIRED) SOURCES. INFECTIOUS ENDOCARDITIS (IE) IS AN INFECTION OF THE ENDOCARDIAL SURFACE OF THE HEART, WHICH MAY INCLUDE ONE OR MORE HEART VALVES, THE MURAL ENDOCARDIUM, OR A SEPTAL DEFECT. INFECTIVE ENDOCARDITIS CAN POTENTIALLY LEAD TO LEAFLET DISRUPTION. TYPICALLY, INFECTIVE ENDOCARDITIS CONSISTS OF LARGE VEGETATIONS WHICH HAVE MANIFESTED FROM BACTERIA. REPORTED ENDOCARDITIS AGENTS ARE MOST COMMONLY MICROBES THAT INHABIT THE HUMAN BODY (E.G. SKIN, MUCOUS MEMBRANES, RESPIRATORY TRACT, INTESTINAL TRACT, OR COMMON INFECTIONS), OR THE ENVIRONMENT, AND CAN CONTRIBUTE TO NOSOCOMIAL SOURCES OF IE. FOR EXAMPLE, THE MOST COMMON BACTERIA OF IE INCLUDE STAPHYLOCOCCUS, STREPTOCOCCUS, AND ENTEROCOCCUS. STREPTOCOCCI RELATED BACTERIAL ENDOCARDITIS IS LINKED TO PATIENT TRANSIENT BACTEREMIA ORIGINATING FROM DENTAL PLAQUE AND DECAY. VARIOUS MICROBES ARE FOUND IN ORAL CAVITIES AND CAN BE TRANSMITTED THROUGH THE BLOODSTREAM FROM DISRUPTION OF THE ORAL MUCOSA OR AFTER DENTAL WORK. IN THIS CASE, THE PATIENT HAD POSITIVE BLOOD CULTURES FOR STREPTOCOCCUS, STATUS POST DENTAL EXTRACTIONS. EDWARDS LIFESCIENCES PRODUCES AND PROVIDES STERILE TISSUE BIOPROSTHESES TO ITS CUSTOMERS BY FOLLOWING CAREFULLY DESIGNED ROBUST STERILIZATION PROCESSES. THESE MANUFACTURING PROCESSES HAVE BEEN VALIDATED AND DEMONSTRATED TO CONSISTENTLY PROVIDE A SIGNIFICANT SAFETY FACTOR FROM WHICH MICROORGANISMS COULD NOT SURVIVE. MICROBIOLOGY AND PROCESS MONITORING IS ROUTINELY REVIEWED WITHIN QUALITY SYSTEMS TO MAINTAIN STERILITY CONTROL. VALIDATED TESTING HAS DEMONSTRATED THAT MICROORGANISMS COULD NOT SURVIVE EDWARDS¿ MULTI-STAGE PROCESSING WITH ENHANCED STERILANT OR HEATED GLUTARALDEHYDE TERMINAL STERILANT SOLUTION. THESE MULTIPLE, REDUNDANT MANUFACTURING CONTROLS ENSURE THE STERILITY OF EDWARDS¿ VALVES AS PROVIDED TO CUSTOMERS. THEREFORE THE PROBABILITY OF ENDOCARDITIS RELATED TO EDWARDS¿ BIOPROSTHESES IS REMOTE. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED WITHOUT THE EXPLANTED VALVE, IT APPEARS THAT THE PATIENT'S INFECTION WAS LIKELY RELATED TO HIS DENTAL WORK. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE VALVE.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1 YEAR DUE TO PROSTHETIC AORTIC VALVE ENDOCARDITIS WITH GROUP ALPHA STREPTOCOCCUS. PER THE OP REPORT, PATIENT ALSO HAD SEVERE PROSTHETIC AORTIC VALVE STENOSIS WITH A MEAN GRADIENT OF 39 MMHG AND A PEAK OF 67.6. DURING EXPLANTATION, A LARGE MOBILE VEGETATION ON THE RIGHT CORONARY CUSP WAS IDENTIFIED. THERE WAS ALSO A MODERATE TO SEVERE AMOUNT OF PANNUS ON THE INTERIOR PORTION OF THE VALVE, WHICH WAS EXCISED SHARPLY. THE VALVE WAS REMOVED AND THE PANNUS WAS DEBRIDED AS WELL AS THE POCKET ON THE RIGHT CORONARY CUSP. A NEW EDWARDS PROSTHETIC VALVE WAS SEATED AND TIED. PATIENT WAS SUCCESSFULLY WEANED FROM CARDIOPULMONARY BYPASS. THERE WERE NO OBVIOUS COMPLICATIONS. PATIENT WAS TRANSFERRED TO THE ICU IN STABLE YET CRITICAL CONDITION. POSTOPERATIVELY, THE PATIENT WAS FOUND TO HAVE A NEUROLOGIC DECLINE. AFTER NEUROSURGICAL AND NEUROLOGICAL CONSULTATION, PATIENT WAS FOUND TO HAVE ANOXIC BRAIN INJURY. DUE TO HIS POOR PROGNOSIS, CARE WAS WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392588 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death| L| R