BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2242020 · Received September 9, 2011

    Report

    Report Number
    2015691-2011-16158
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 11, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO INCONSISTENCIES DETECTED IN THE RETURNED VALVE. THE LEAFLETS ARE INTACT AND FLEXIBLE. NO INCONSISTENCIES DETECTED IN THE X-RAY AS THE WIREFORM IS INTACT. X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE EVALUATION RESULTS CONFIRM THAT THE EDWARDS VALVE WAS FUNCTIONING PROPERLY; NO DEVICE MALFUNCTION. THE INFORMATION SUGGESTS THAT THE LEAK EXPERIENCED WAS LIKELY DUE TO THE PATIENT'S PRE-EXISTING FRIABLE TISSUE.

    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 AT IMPLANT. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS NOTED THAT THE PATIENT NEEDED "REPAIR OF LV RUPTURE - REPLACED AVR." ACCORDING TO THE OPERATIVE REPORT, "THE PATIENT IS AN (B)(6) GENTLEMAN WHO PRESENTS WITH INCREASING SHORTNESS OF BREATH AND FATIGABILITY, WITH A LONGSTANDING MURMUR OF AORTIC VALVULAR STENOSIS. HE UNDERWENT ECHO, WHICH DEMONSTRATED CRITICAL AORTIC VALVE STENOSIS AND MODERATE MITRAL VALVULAR INSUFFICIENCY... THE PATIENT'S AORTIC VALVE WAS ABLE TO BE REPLACED WITH A 25 CE MAGNA THERMAFIX PERICARDIAL VALVE. UPON WEANING FROM CARDIOPULMONARY BYPASS, THOUGH, THE PATIENT WAS NOTED TO HAVE A SMALL PERIVALVULAR LEAK. AT THIS POINT, IT WAS NOTED THAT A FAIR AMOUNT OF FRIABILITY OF THE TISSUES WAS BECOMING MANIFEST WITH VERY FRIABLE AORTA AND ATRIA, AND THE NEED TO RETURN TO THE HEART/LUNG MACHINE TO REPAIR THIS PERIVALVULAR LEAK LENT THE DECISION TO OPEN THE STERNUM IN ITS ENTIRETY. THIS WAS ABLE TO BE ACCOMPLISHED AND THE PERIVALVULAR LEAK EASILY FIXED." THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. ADDITIONALLY, IT WAS INDICATED BY THE HEALTH-CARE PROVIDER THAT THE REASON FOR EXPLANTING THE VALVE WAS NOT RELATED TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-11E1618

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention