BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10.

    MDR report key: 10729473 · Received October 23, 2020

    Report

    Report Number
    2015691-2020-14108
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    September 29, 2020
    Report Date
    September 29, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10.
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H11. CORRECTED DATA: CORRECTED D4 SERIAL NUMBER TO ASKU. SERIAL NUMBER ORIGINALLY PROVIDED IS INVALID. SERIAL NUMBER REMAINS UNKNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION IS IN PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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) WHICH OCCURS AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), DEHISCENCE, FIBROSIS OR NON-CALCIFIC DEGENERATION AND/OR ENDOCARDITIS. THE CAUSE OF THE EVENT CANNOT BE DETERMINED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESOS , MODEL# 6625LP, PMA# P870077.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT THIS PATIENT WITH A 31MM MITRAL PORCINE VALVE UNDERWENT INTERVENTION FOR A VALVE-IN-VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF 13 YEARS AND 1 MONTH FOR UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188328 SEE H10. REPLACEMENT HEART-VAVLE DYE EDWARDS LIFESCIENCES SEE H10.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R