BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H10

    MDR report key: 7219505 · Received January 25, 2018

    Report

    Report Number
    2015691-2018-00275
    Event Type
    Malfunction
    Date Received
    January 25, 2018
    Date of Event
    January 1, 2018
    Report Date
    January 5, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: UPDATED EVENT OR PROBLEM.

    Description of Event or Problem · 0

    EDWARDS RECEIVED ADDITIONAL INFORMATION THROUGH FOLLOW-UP THAT THE VALVE WAS EXPLANTED. NO ADDITIONAL DETAILS WERE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED, MARKETED, OR SOLD IN THE U.S.; HOWEVER, IT IS SIMILAR TO MODEL 2800 WHICH IS MARKETED IN THE U.S., PMA NUMBER P860057/S001. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE CLINICAL OBSERVATION WAS UNABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. STRUCTURAL VALVE DETERIORATION (SVD), A COMMON REASON FOR BIOPROSTHESIS EXPLANT OR REOPERATION, ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFIC AND NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. A MANUFACTURING NON-CONFORMANCE WAS NOT IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. THE INSTRUCTIONS FOR USE (IFU) HAS BEEN REVIEWED AND NO INADEQUACIES WERE IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS THROUGH THE USE OF EDWARDS QUALITY SYSTEMS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A PATIENT WITH AN EDWARDS AORTIC VALVE IS LEAKING AFTER AN IMPLANT DURATION OF APPROXIMATELY 13 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62760 H10 HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES H10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization