BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 2853794 · Received December 3, 2012

    Report

    Report Number
    2015691-2012-18741
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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 CHECK UNDER MAGNIFICATION PER SOP. (B)(4). THEREFORE, DUE TO THESE REDUNDANT INSPECTION STEPS, THE LIKELIHOOD OF DEVICES CONTAINING PARTICULATES BEING RELEASED TO THE CUSTOMER IS SIGNIFICANTLY REDUCED. SINCE THE SOURCE OF THE SILK AND CELLOPHANE LIKE MATERIALS CANNOT BE CONCLUSIVELY DETERMINED, AND THE OCCURRENCE OF SIMILAR EVENTS IS REMOTE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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. EVALUATION SUMMARY ATTACHED: CUSTOMER REPORT OF FOREIGN BODY ON LEAFLET WAS CONFIRMED. AS RECEIVED BLACK FILAMENTS WERE EVIDENT IN THE CUSP AREA OF 2 LEAFLETS AT THE INFLOW ASPECT, AS WELL AS A BLUE FILAMENT. BLACK SPECKS WERE ALSO NOTED ON THE INFLOW ASPECT. VALVE WAS RINSED WITH WATER AND FILAMENTS WERE NOT REMOVED FROM INFLOW SIDE OF LEAFLETS. SAMPLES WILL BE SENT TO CHEMISTRY FOR EVALUATION. ADDITIONAL MANUFACTURER NARRATIVE: PARTICULATE WAS REMOVED FROM THE DEVICE AND SENT TO CHEMISTRY FOR ANALYSIS. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ADDITIONAL INVESTIGATION WAS CONDUCTED INTO EDWARDS' RETURNED VALVE, FOCUSED ON THE FOUR (4) MICROSCOPIC PARTICULATES FOUND ON INFLOW SIDE OF TISSUE LEAFLETS. THESE FOUR UNKNOWN PARTICULATES (FIBER LIKE MATERIALS) WERE REMOVED FROM THE PRODUCT BY PRODUCT EVALUATION LAB PERSONNEL PRIOR TO EVALUATION. IR SPECTRUM TESTING DONE BY EDWARDS LIFESCIENCES CHEMISTRY RESULTS INDICATE: DSI2-291A - THE IR SPECTRUM OF THE UNKNOWN PARTICULATE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO CELLOPHANE LIKE MATERIAL. DS12-291B - DUE TO MICROSCOPIC SIZE OF THE PARTICLE, SAMPLE WAS INADVERTENTLY LOST DURING TRANSFER TO GOLD MIRROR PLATE FROM UNI-CASSETTE. DSI2-291C -THE LR SPECTRUM OF THE UNKNOWN PARTICULATE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO CELLOPHANE LIKE MATERIAL. DS12-291D - THE IR SPECTRUM OF THE UNKNOWN PARTICULATE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO SILK LIKE MATERIAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT THAT OCCURED DURING AN AORTIC VALVE REPLACEMENT PROCEDURE BY (B)(6). WHEN RINSING A SIZE 23MM AORTIC CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, FOREIGN BODY (HAIR) WAS EMBEDDED IN A LEAFLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 3129932

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening