BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2231317 · Received September 1, 2011

    Report

    Report Number
    2015691-2011-16130
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    April 27, 2011
    Report Date
    August 5, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VEGETATIONS ON VALVE. DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. IN THIS CASE, IT WAS INDICATED THAT THE PATIENT WAS DISCOVERED TO HAVE ESCHERICHIA COLI URINARY TRACT INFECTION. ADDITIONALLY, THE PATIENT UNDERWENT BLOOD CULTURES, WHICH CAME BACK POSITIVE FOR COAG-NEGATIVE STAPH.

    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, IT WAS LEARNED FROM OUR IMPLANT PATIENT REGISTRY THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 MONTHS. IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS INVOLVING THE PROSTHETIC MITRAL VALVE. ACCORDING TO THE OPERATIVE REPORT, "[THE PATIENT] IS A (B)(6) YEAR-OLD WOMAN WHO PRESENTED WITH RADIATION-INDUCED VALVITIS INVOLVING THE AORTIC AND MITRAL VALVES, AS WELL AS PREVIOUS CORONARY DISEASE. THE PATIENT HAD CONGESTIVE HEART FAILURE AND UNDERWENT DOUBLE VALVE REPLACEMENT WITH TISSUE VALVES AND CORONARY BYPASS GRAFTING TO THE OBTUSE MARGINAL BRANCH OF THE CIRCUMFLEX. THE PATIENT RE-PRESENTED POSTOPERATIVELY, NOW FIVE MONTHS POSTOP, WITH FEVER, MALAISE, AND POSITIVE BLOOD CULTURES FOR COAG-NEGATIVE STAPH. THE PATIENT WAS PLACED ON IV ANTIBIOTICS. ECHO CONFIRMED THE PRESENCE OF MITRAL VALVE VEGETATION WITH NO SIGNIFICANT MR. THE PATIENT DID HAVE GOOD LV FUNCTION. NO EVIDENCE OF VEGETATION OR INVOLVEMENT OF THE AORTIC VALVE PROSTHESIS. THE PATIENT WAS TRANSFERRED FOR REDO STERNOTOMY AND REDO MITRAL VALVE REPLACEMENT." UPON REMOVAL, THE MITRAL VALVE WAS NOTED TO BE ABNORMAL. "THERE WAS EVIDENCE OF ENDOCARDITIS WITH VEGETATION PRESENT IN THE POSTERIOR ASPECT OF THE MITRAL VALVE ANNULUS. THERE WAS SOME ASSOCIATED SPREAD OF THE INFECTION TO THE LEVEL OF THE SEWING CUFF. THERE WAS NO ANNULAR ABSCESS." THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX R-10K2816

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R