BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3232982 · Received July 18, 2013

    Report

    Report Number
    2015691-2013-20632
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PATIENT HAS A HISTORY OF ENDOCARDITIS. 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. ENDOCARDITIS OF A VALVE OFTEN REQUIRES REPLACEMENT. IT IS NOT UNUSUAL TO HAVE A RECURRENCE OF ENDOCARDITIS THAT RESULTS EITHER IN DEATH OR REMOVAL OF THE IMPLANTED DEVICE. IT WAS REPORTED THAT THIS PATIENT EXPIRED DURING THIS PROCEDURE FROM IRREVERSIBLE CARDIOGENIC SHOCK. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED, IT APPEARS THAT THE PATIENT LIKELY EXPIRED FROM COMPLICATIONS OF HIS INFECTION. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EDWARDS VALVE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PATIENT HAD REDO-AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 MONTHS. THE SURGEON INDICATED THAT THIS EVENT WAS DUE TO PATIENT RELATED FACTORS AND NOT A DEVICE MALFUNCTION. THE VALVE WAS EXPLANTED DUE TO ENDOCARDITIS AND PARAVALVULAR LEAK (PVL). PER THE OP REPORT, THE PATIENT PRESENTED WITH EVIDENCE OF PVL SECONDARY TO THE FIBROUS TRIGONE DISRUPTION. EVEN THOUGH HE WAS NOT FEBRILE OR BACTEREMIC, IV ANTIBIOTICS WERE PUT ON. REFERRAL FOR ATTEMPTED PERCUTANEOUS CLOSURES WERE DENIED SECONDARY TO THE POSSIBILITY OF ENDOCARDITIS. DURING EXPLANTATION OF THE AORTIC PROSTHESIS, THE FIBROUS TRIGONE WAS THEN NOTED TO BE COMPLETELY DESTROYED. THE ONLY AREA OF DEHISCENCE WAS AT THE FIBROUS TRIGONE. IT WAS INITIALLY DECIDED TO PRESERVE THE AORTIC VALVE AND PERFORM A PATCH REPAIR OF THE FIBROUS TRIGONE. HOWEVER, AFTER WEANING THE PATIENT OFF CARDIOPULMONARY BYPASS (CPB), THERE WAS SEVERE MITRAL AND AORTIC INSUFFICIENCY (AI), AGAIN THROUGH THE FIBROUS TRIGONE. IT WAS DECIDED TO PLACE THE PATIENT BACK ON CPB AND RE-EXPLORE THE AORTIC VALVE. THERE WERE OTHER AREAS OF DEHISCENCE NOT PREVIOUSLY SEEN; THEREFORE, THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. THERE SEEMED TO BE LESS AI. THE PATIENT WAS WEANED OFF CPB ONCE AGAIN. UNFORTUNATELY, THE PATIENT WAS IN IRREVERSIBLE CARDIOGENIC SHOCK IN SPITE OF WIDE OPEN PRESSORS AND INOTROPES AND THE PATIENT WAS PRONOUNCED AT 7:30 P.M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334620 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R