BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 2080918 · Received May 7, 2011

    Report

    Report Number
    2015691-2011-15477
    Event Type
    Injury
    Date Received
    May 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: (B)(4) = DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: PRODUCT NAME, MODEL AND SERIAL NUMBER WERE NOT REPORTED AND THE PRODUCT WILL NOT BE RETURNED. THE IMPLANT DATE WAS REPORTED ONLY AS "(B)(4) 2011". THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE DONE WITHOUT THE DEVICE SERIAL NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING: A 23MM BIOPROSTHETIC VALVE WAS EXPLANTED AT IMPLANT DUE TO THE CALCIFIED NATURE OF THE PSEUDO ANNULUS. THE PATIENT HAD UNDERGONE THE REPLACEMENT OF HIS AORTIC ROOT APPROX 15 YEARS PREVIOUS TO THIS PROCEDURE. A HOMOGRAFT WAS INSERTED WHICH WITH THE PASSING OF TIME HAD CALCIFIED AND SUFFERED FROM LEAFLET DEGRADATION. DURING LATE (B)(6) 2011, IT WAS DECIDED TO PERFORM A SURGICAL AORTIC VALVE PROCEDURE AND A 23 MM EDWARDS PERIMOUNT VALVE WAS INSERTED VIA AN OPEN STERNOTOMY. UNFORTUNATELY, DUE TO THE CALCIFIED NATURE OF THE PSEUDO ANNULUS, THIS WAS NOT WITHOUT EVENT AND ACHIEVING A GOOD SEAL WITHOUT SIGNIFICANT PARAVALVULAR LEAKAGE WAS NOT POSSIBLE. THE PATIENT'S CONDITION CONTINUED TO DETERIORATE. IT WAS DECIDED TO TRY TO REOPEN THE STERNUM AND AORTA AND REMOVE THE PERIMOUNT VALVE REPLACING IT WITH A SAPIEN VALVE. THAT A SATISFACTORY RESULT WAS NOT ACHIEVED IS PURELY BECAUSE OF THE PATIENTS ANATOMICAL FACTORS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R