BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3230373 · Received July 16, 2013

    Report

    Report Number
    2015691-2013-20621
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 OP REPORT DOCUMENTS A HISTORY OF ENDOCARDITIS REQUIRING VALVE REPLACEMENT. THE PATIENT ALSO HAS A PREVIOUS HISTORY OF IV DRUG ABUSE. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED WITHOUT THE SAMPLE DEVICE, IT APPEARS THAT THIS EVENT WAS LIKELY RELATED TO THE PATIENT PREVIOUS INFECTION. 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.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 18 MONTHS DUE TO RECURRENT TRICUSPID PROSTHETIC VALVE ENDOCARDITIS. PER THE OP REPORT, THIS PATIENT HAS A HISTORY OF PREVIOUS IV DRUG ABUSE WITH TRICUSPID VALVE ENDOCARDITIS REQUIRING TRICUSPID VALVE REPLACEMENT (TVR) IN 2011. HE PRESENTED IN EARLY 2012 WITH RECURRENT ENDOCARDITIS FOR WHICH HE UNDERWENT 6-8 WEEKS OF ANTIBIOTICS. RECENTLY, HE WAS ADMITTED AGAIN AND WAS FOUND TO BE SEPTIC WITH MRSA BACTEREMIA. THIS WAS THE SAME ORGANISM AS HIS ENDOCARDITIS. ECHO SHOWED SIGNIFICANTLY THICKENED TRICUSPID VALVE WITH REGURGITATION. PATIENT WAS REFERRED FOR REDO-TVR. DURING EXPLANTATION OF THE PROSTHETIC VALVE, THERE WAS NO OBVIOUS ANNULAR ABSCESS. THE VALVE WAS WELL SEATED. THERE WAS SIGNIFICANT DESTRUCTION AND OVERGROWTH OF ENDOCARDITIS ON THE OLD VALVE. THIS WAS REMOVED AND ANOTHER EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED. PATIENT WAS WEANED OFF CARDIOPULMONARY BYPASS. IT WAS NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329035 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX

    Patients

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