BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 3801167 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01076
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 6, 2013
    Report Date
    April 11, 2014
    Manufacturer
    UNK
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE REMAINS IMPLANTED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THAT THIS MITRAL BIOPROSTHETIC VALVE IS A NON-EDWARDS DEVICE. THE MANUFACTURER OF THE VALVE REMAINS UNKNOWN. THEREFORE, THE BRAND NAME, MODEL NUMBER AND PMA NUMBER ARE BEING REDACTED. THE SERIAL NUMBER THAT WAS ORIGINALLY REPORTED IS AN EDWARDS SERIAL NUMBER - HOWEVER, THIS IS FOR AN AORTIC BIOPROSTHESIS WHEREAS THIS REPORT PERTAINS TO A MITRAL BIOPROSTHESIS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE CUSTOMER THAT A PATIENT HAS A MITRAL VALVE THAT IS EXPERIENCING SEVERE REGURGITATION. WHEN MADE AWARE, THE LENGTH OF IMPLANTATION WAS ONE (1) YEAR, SEVEN (7) MONTHS. THE PATIENT WAS DIAGNOSED WITH RHEUMATIC HEART DISEASE (RHD). NO ADDITIONAL DETAILS WERE PROVIDED AND THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THIS DEVICE IS A NON-EDWARDS BIOPROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278508 SEE H10 REPLACEMENT HEART VALVE DYE UNK SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR