BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 3012960 · Received March 20, 2013

    Report

    Report Number
    2015691-2013-19596
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CUSTOMER REPORT OF PARTICULATES ON THE LEAFLET WAS CONFIRMED. BLACK, BROWN AND BLUE FILAMENTS WERE EVIDENT AT THE CUSP AREA OF ALL THREE LEAFLETS AT THE INFLOW ASPECT. THE FILAMENTS VARY IN SIZE AND MEASURE FROM APPROXIMATELY LESS THAN 1MM-3MM. AS RECEIVED, THE VALVE WAS ATTACHED TO THE HOLDER. NO SUTURE HOLES WERE DETECTED IN THE SEWING RING. PARTICULATES WERE ISOLATED AND SENT TO CHEMISTRY FOR ANALYSIS. CHEMISTRY REPORT: IR SPECTRUM OF THE UNKNOWN PARTICLE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO CELLOPHANE LIKE MATERIAL. IR SPECTRUM OF THE UNKNOWN PARTICLE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO CELLOPHANE LIKE MATERIAL. IR SPECTRUM OF THE UNKNOWN PARTICLE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO CELLOPHANE LIKE MATERIAL. SAMPLE WAS INADVERTENTLY LOST DURING TRANSFER TO THE ATR PLATFORM FROM SAMPLE CASSETTE. THE UNKNOWN PARTICULATE COULD NOT BE IDENTIFIED. METHOD: X-RAY. EACH VALVE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO PACKAGING. DURING MANUFACTURE OF THE HEART VALVES THERE ARE INSPECTION STEPS WHICH CHECK FOR GENERAL APPEARANCE AND INSPECT THE LEAFLETS UNDER MAGNIFICATION. SUBSEQUENTLY IN THE PRELIMINARY PACKAGING STEPS, WHICH ARE PERFORMED IN A CLASS 10,000 CLEANROOM UNDER A CLASS 100 HOOD, THE VALVES UNDERGO A 100% INSPECTION FOR FOREIGN PARTICULATES. THIS IS PERFORMED FOR 100% OF ALL VALVES IN THE WORK ORDER. THEREFORE DUE TO THESE REDUNDANT INSPECTION STEPS, THE LIKELIHOOD OF DEVICES CONTAINING PARTICULATES BEING RELEASED TO THE CUSTOMER IS SIGNIFICANTLY REDUCED. SINCE THE MATERIAL WAS IDENTIFIED AS A FIBER, AND THERE IS NO INCREASE IN OCCURRENCE, NO FURTHER CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    MODEL #: THIS DEVICE IS NOT DISTRIBUTED, MARKETED, OR SOLD IN THE U.S.; HOWEVER, IT IS SIMILAR TO MODEL NO. 2800 WHICH IS MARKETED IN THE U.S. METHOD: DEVICE NOT RECEIVED FOR EVALUATION. CONCLUSION: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. DEVICE WAS RECEIVED BY AND FORWARDED FROM OUR OFFICE IN (B)(4) TO THE U.S. FOR EVALUATION. THE DEVICE IS CURRENTLY IN TRANSIT AND EVALUATION WILL BE CONDUCTED AS SOON AS RECEIVED. SUPPLEMENTAL WILL BE FILED WITH EVALUATION RESULTS. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    REPORTEDLY, PARTICULATES WERE DETECTED ON THE DEVICE. THE VALVE WAS NOT USED AND WILL BE RETURNED FOR EVALUATION. THE SURGEON REPORTED HE FOUND SOME BLACK PARTICLES STUCK ON THE TISSUE LEAFLET WHICH HE TRIED WASHING WITH NORMAL SALINE BUT THOSE PARTICLES COULD NOT COME OUT. HE SAW THIS AT THE TIME OF IMPLANT ONLY SO HE DID NOT IMPLANT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115261 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 12J277

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR