BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS-DUROMEDICS BILEAFLET PROSTHESIS

    MDR report key: 92891 · Received May 20, 1997

    Report

    Report Number
    6000002-1997-00447
    Event Type
    Death
    Date Received
    May 20, 1997
    Date of Event
    September 14, 1996
    Report Date
    April 21, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H3: EXAMINATION OF THE VALVE IN CO'S LABORATORY CONFIRMED THAT THE RIGHT LEAFLET WAS MISSING FROM THE DEVICE. THE RIGHT LEAFLET REVEALED THAT ONE PIVOT BALL WAS MISSING. THE INFLOW ASPECTS OF THE VALVE AND SEWING RING APPEARED NORMAL EXCEPT FOR A HARD, NODULAR, CALCIFIC REGION NOTED OUTWARD FROM THE RIGHT SAFETY STOP. THE HOUSING SEATING LIP AND LEAFLET MAJOR RADIUS CONTACT REGIONS SHOWED ONLY VERY SLIGHT SIGNS OF CONTACT WEAR AND ONE LOCATION OF VERY SLIGHT PITTING OF THE SEATING LIP. THIS PIT IS APPROXIMATELY 0.7MM INBOARD OF THE CONTACT REGION WITH SOME ASSOCIATED VERY SLIGHT MICROCRACKING. THE PIVOT SLOTS OF THE INTACT LEAFLET (LEFT LEAFLET) SHOWED SUBSTANTIAL PITTING IN THE LOWER PORTION OF THE SLOT EDGES NEAR THE TRISECTOR. THERE WAS ALSO EVIDENCE OF CLUSTERED MICROPOROSITY. OF THE CORRESPONDING PIVOT BALLS, #3 SHOWED A VERY DEEP PIT WITH ADJOINING WEAR SCAR WHILE PIVOT BALLS #4 SHOWED ONLY A VERY SLIGHT PIT. PIVOT BALL #2 OF THE ESCAPED LEAFLET (RIGHT LEAFLET) SHOWED A VERY SLIGHT PIT/CHIP ON THE PIVOT SLOT EDGE AND PIVOT SLOT #1 SHOWED A SLIGHT PIT AND SLIGHT LINEAR EROSION. ON THE CORRESPONDING PIVOT BALLS, #2 SHOWED ONLY A VERY SLIGHT PIT AND THE WHOLE REGION OF THE PIVOT WAS MISSING FOR PIVOT BALL #1. THERE WAS NO FRACTURE ORIGIN EVIDENT. X-RAY REVEALED A DETACHED LEAFLET WITH ONE PIVOT BALL MISSING. IN SUMMARY, THIS VALVE EXHIBITED AN EXCAPED LEAFLET DUE TO FRACTURE OF THE REGION CONTAINING PIVOT BALL #1. THERE WAS SOME DAMAGE TO THE CORRESPONDING PIVOT SLOT EDGE NOTED. THIS PIVOT BALL REGION FRACTURE WAS VERY UNUSUAL FOR SEVERAL REASONS; 1) THE LOCATION OF THE FRACTURE WAS SUCH THAT THE END OF THE LEAFLET THAT CARRIES THE PIVOT-BALL-LOCATING STRUCTURE WAS ALMOST TOTALLY GONE, 2) THERE WAS NO EVIDENCE OF AN INITIATION SITE FOR THE FRACTURE, AND 3) THERE WERE SEVERAL EXTENSIVE SECONDARY CRACKS IN THE REGION. NONE OF THESE OBSERVATIONS HAVE BEEN ASSOCIATED WITH PREVIOUSLY EXAMINED PIVOT BALL FRACTURES. X-RAY, SEM, ECX ANALYSES.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE HOSPITAL BECAUSE OF DIFFICULTY IN BREATHING WITH SUSPECTED ASTHMA AND DIED THREE DAYS LATER. ON AUTOPSY, A LEAFLET WAS FOUND IN THE TRUNCUS BRANCHEOCEPHALICUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS-DUROMEDICS BILEAFLET PROSTHESIS Implant REPLACEMENT HEART VALVE LWQ BAXTER HEALTHCARE CORP. 9120 88

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death