BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3771824 · Received April 24, 2014

    Report

    Report Number
    2015691-2014-00945
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 27, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VSD. ADDITIONAL MANUFACTURER NARRATIVE: IT WAS REPORTED THAT THIS VALVE WAS EXPLANTED DUE TO AORTIC INSUFFICIENCY. AORTIC REGURGITATION (AR) IN BIOPROSTHETIC HEART VALVES, ALSO KNOWN AS AORTIC INSUFFICIENCY, OCCURS WHEN THE VALVE DOES NOT CLOSE PROPERLY IN DIASTOLIC PHASE, WHICH RESULTS IN RETROGRADE FLOW OF BLOOD INTO THE LEFT VENTRICLE. IF THE REGURGITATION WORSENS OR BECOMES SYMPTOMATIC, REOPERATION MAY BE NECESSARY. THE OPERATIVE REPORT NOTES INFECTED TISSUE UNDERNEATH THE VALVE. THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE EVENT; HOWEVER, THE AORTIC INSUFFICIENCY WAS LIKELY RELATED TO THE PATIENT'S INFECTION. THERE IS NO INFORMATION SUGGESTING THERE WAS A MALFUNCTION OR DEFICIENCY OF THE EDWARDS VALVE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THIS VALVE WAS EXPLANTED DUE TO 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. THE HEALTHCARE PROVIDER REPORTED THAT THERE WAS NO MALFUNCTION OF THE EDWARDS VALVE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO FURTHER ACTIONS ARE BEING TAKEN.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT." THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, EDWARDS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED APPROXIMATELY SIX (6) WEEKS, WAS EXPLANTED. IT WAS IDENTIFIED, THROUGH REVIEW OF SOURCE DOCUMENTATION PROVIDED, THAT THE PATIENT HAD SEVERE AORTIC INSUFFICIENCY. THE PATIENT HAD QUESTIONABLE INFECTED PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECTS AFTER RECENT AORTIC VALVE REPLACEMENT AND SUBANNULAR ABSCESS FOR ENDOCARDITIS. THE PATIENT WAS NOTED TO BE A DRUG ADDICT. DURING EXPLANTATION, THE VALVE DID NOT APPEAR INFECTED. THE DEVICE WAS REPLACED WITH A NEW BIOPROSTHETIC VALVE. THE PATIENT WAS HEMODYNAMICALLY STABLE POST-IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249883 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX S-13C1130

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R