BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 2001454 · Received February 25, 2011

    Report

    Report Number
    2015691-2011-14897
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 25, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, A BLACK FILAMENT WAS EVIDENT AT THE OUTFLOW. THE FILAMENT MEASURED TO APPROXIMATELY 11MM. OTHER PARTICULATES WERE ALSO DETECTED AT THE INFLOW ASPECT; TWO OTHER FILAMENTS WERE ISOLATED AND THEY MEASURED APPROXIMATELY TO LESS THAN 3MM. THE SECOND FILAMENT WAS BLACK IN COLOR AND THE THIRD FILAMENT WAS BLUE IN COLOR. ALTHOUGH OTHER PARTICULATES WERE DETECTED AT THE INFLOW ASPECT, ISOLATION OF THE PARTICULATES WAS NOT POSSIBLE DUE TO THEIR MICRO SIZE. FILAMENTS FOUND ONTO THE VALVE TISSUE EXAMINED VISUALLY AND WITH A DIGITAL MICROSCOPE. ALL THREE FILAMENTS WERE SENT TO CHEMISTRY ANALYTICAL LABORATORY FOR EVALUATION. LABORATORY RESULTS CONCLUDED THAT THE IR SPECTRUM OF THE UNKNOWN FIRST FILAMENT SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO POLYACRYLONITRILE. THE SECOND WHICH IS ALSO BLACK IN COLOR WAS FOUND TO BE SIMILAR CHARACTERISTICS WHEN COMPARING TO CELLULOSE LIKE MATERIAL. FINALLY THE THIRD BLUE FILAMENT WAS SIMILAR TO POLYESTER LIKE MATERIAL. SUBSEQUENTLY, EDWARDS ENGINEERING CONDUCTED A THOROUGH SEARCH OF ALL MATERIALS UTILIZED IN THE MANUFACTURING PROCESSES OF THIS DEVICE, AND CONCLUDED THAT NO MATERIALS MATCHING THE PHYSICAL AND CHEMICAL CHARACTERISTICS OF THE SUBJECT FOREIGN FILAMENTS WERE FOUND. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE INVESTIGATION REVEALS NO QUALITY DEFICIENCIES DURING MANUFACTURING. THE ORIGIN OF THE FOREIGN MATERIALS IS INCONCLUSIVE; HOWEVER IT IS HIGHLY UNLIKELY TO HAVE ORIGINATED FROM EDWARDS' PROCESSES.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.ADDITIONAL MANUFACTURER NARRATIVE - THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS.RETURN OF THE DEVICE AND A COPY OF THE OPERATIVE REPORT HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE OPERATING ROOM STAFF FOUND A FIBER ON A REPLACEMENT HEART VALVE. THIS WAS DETECTED AFTER OPENING THE PACKAGING AND BEFORE USE IN THE PATIENT. THE DEVICE WAS NOT USED AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS HEART VALVE REPLACEMENT DYE EDWARDS LIFESCIENCES 3000TFX R-10F1674

    Patients

    Seq Age Sex Outcome Treatment
    1