BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 3223084 · Received July 12, 2013

    Report

    Report Number
    2015691-2013-20581
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VEGETATIONS. 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 PATIENT'S MEDICAL RECORDS DOCUMENT A HISTORY OF (B)(6) REQUIRING MITRAL VALVE REPLACEMENT. 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. IT APPEARS THAT THE PATIENT'S ENDOCARDITIS MAY HAVE BEEN RELATED TO HER PREVIOUS CASE OF ENDOCARDITIS. HOWEVER, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITHOUT THE SAMPLE DEVICE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 YEARS DUE TO ENDOCARDITIS. PER THE PATIENT'S PRE-OP WORKUP, SHE HAS A HISTORY OF (B)(6) REQUIRING MITRAL VALVE REPLACEMENT (MVR) IN 2008 (IMPLANTATION OF SUBJECT DEVICE). THE PATIENT RECENTLY UNDERWENT TEE SHOWING SEVERE MITRAL REGURGITATION AND VEGETATION OF THE PROSTHETIC MITRAL VALVE. THE PATIENT UNDERWENT REDO-MVR WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323607 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R