BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3203271 · Received July 2, 2013

    Report

    Report Number
    2015691-2013-20519
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 3, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. IN THIS CASE, THE SURGEON CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE EDWARDS VALVE. THE INFECTION SOURCE WAS PROVIDED AS: FUNGAL. 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. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 MONTHS. THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO PROSTHETIC AORTIC VALVE ENDOCARDITIS WITH STENOSIS AND REGURGITATION. THE SURGEON ALSO NOTED THAT THE INFECTION SOURCE WAS FUNGAL; THERE WAS NO MALFUNCTION OF THE EXPLANTED VALVE. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302886 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 3464831

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R