BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 2063410 · Received April 19, 2011

    Report

    Report Number
    2015691-2011-15259
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 21, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - LEAFLET DISRUPTION. 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. THERE ARE SEVERAL POTENTIAL CAUSES FOR PROSTHETIC VALVE STENOSIS (E.G. CALCIFICATION, PANNUS GROWTH). UNFORTUNATELY, THE VALVE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS, AND THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE INVESTIGATED.

    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 REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO TRICUSPID STENOSIS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT HAD MITRAL AND TRICUSPID VALVE REPLACEMENT IN 2010, AND PRESENTED WITH HEMOLYSIS AND PERIVALVULAR LEAK AT HER MITRAL VALVE AND TRICUSPID VALVE STENOSIS. UPON INSPECTION OF THE TRICUSPID VALVE, THERE WAS A LARGE AMOUNT OF MATERIAL ON THE VALVE LEAFLETS, PREDOMINANTLY ON THE VENTRICLE SIDE. THE MATERIAL LOOKED LIKE POTENTIAL INFECTIOUS MATERIAL AND THE VALVE WAS MECHANICALLY OBSTRUCTED BY IT, SO IT WAS DECIDED TO REPLACE IT. FURTHERMORE, THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-10B0334

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention