BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 2220889 · Received August 23, 2011

    Report

    Report Number
    2015691-2011-16086
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 29, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL DATED REPORTED FOR RECEIVED DATE OF DEVICE IS CORRECT AND SHOULD BE REFLECTED AS (B)(6) 2011. WRONG DATE READ FROM FILE.

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE UNKNOWN PARTICLES WERE SENT TO CHEMISTRY FOR ANALYSIS. FTIR ANALYSIS WAS PERFORMED ON FOUR (4) SEPARATE PARTICLE SAMPLES AND CONCLUDED THE IR SPECTRUM SHOWED SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO CELLULOSE LIKE MATERIAL (1), CELLULOSE/LIGNIN LIKE MATERIAL (2), AND SILK LIKE MATERIAL (1). METHOD: FTIR ANALYSIS. ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. CONCLUSION: ALTHOUGH THE SOURCE OF THE CELLULOSE, CELLULOSE/LIGNIN AND SILK LIKE MATERIAL CANNOT BE CONCLUSIVELY DETERMINED, THESE MATERIALS CAN INCLUDE THOSE SUCH AS PAPER OR COTTON, AND SILK. THE EVALUATION IMAGES APPEAR CONSISTENT WITH THE FTIR ANALYSIS RESULTS. DURING MANUFACTURE OF THE HEART VALVES, THERE ARE INSPECTION STEPS WHICH CHECK FOR GENERAL APPEARANCE AND CHECK UNDER MAGNIFICATION. SUBSEQUENTLY, IN THE PRELIMINARY PACKAGING STEPS, WHICH ARE PERFORMED IN A CLASS 10,000 CLEANROOM UNDER A CLASS 100 HOOD, THE VALVES ARE AGAIN INSPECTED FOR FOREIGN PARTICULATES. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE PARTICULATE OBSERVED IN THE COMPLAINT WAS DUE TO THE MANUFACTURING PROCESSES. (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, IT WAS ALLEGED THAT A FLAW WAS ON ONE LEAFLET OF VALVE BEFORE IMPLANTATION. THE VALVE WAS NOT USED. THERE APPEARED TO BE A METALLIC FLAKE PARTIALLY EMBEDDED IN ONE LEAFLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 11D080

    Patients

    Seq Age Sex Outcome Treatment
    1