BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 3884214 · Received June 19, 2014

    Report

    Report Number
    2015691-2014-01410
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO AVAILABLE INFORMATION PROVIDED IDENTIFYING THE NAME, MODEL OR SERIAL NUMBER OF THIS DEVICE. THE DEVICE REMAINS IMPLANTED AFTER A VALVE-IN-VALVE PROCEDURE; THEREFORE, THE DEVICE IS NOT AVAILABLE FOR RETURN AND IDENTIFICATION. SHOULD THIS INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THERE IS NO ADDITIONAL PATIENT HISTORY OR MEDICAL INFORMATION. THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE DONE AT THIS TIME. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. REPLACEMENT OF A BIOPROSTHETIC VALVE OVER TIME IS MORE LIKELY DUE TO STRUCTURAL VALVE DETERIORATION (SVD) AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), DEHISCENCE, FIBROSIS OR NON-CALCIFIC DEGENERATION. IN THIS CASE, THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE IT REMAINS IMPLANTED. THE CAUSE OF THE REPORTED STENOSIS IS MOST LIKELY DUE TO PATIENT RELATED FACTORS. HOWEVER, MINIMAL INFORMATION REGARDING THIS VALVE WAS RECEIVED AND SUBSEQUENT ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE AT THE TIME OF THE PROCEDURE WERE UNSUCCESSFUL; THEREFORE, THE CLINICAL STATEMENTS CANNOT BE CONFIRMED AND THE ROOT CAUSE FOR THE AORTIC STENOSIS REMAINS INDETERMINABLE.

    Description of Event or Problem · 1

    EDWARDS HAS LEARNED OF A VALVE-IN-VALVE PROCEDURE IN A FAILED 27 MM MITRAL PERICARDIAL VALVE DUE TO STENOSIS. THE LENGTH OF IMPLANT IS UNKNOWN AND THE PATIENT INFORMATION IS NOT CURRENTLY AVAILABLE. PATIENT IS REPORTED AS HOSPITALIZED (STABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359832 SEE H10 HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R