BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS-DUROMEDICS BILEAFLET PROSTHESIS DEVICE #1

    MDR report key: 125987 · Received October 8, 1997

    Report

    Report Number
    6000002-1997-00749
    Event Type
    Death
    Date Received
    October 8, 1997
    Date of Event
    September 5, 1997
    Report Date
    September 9, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP. EDWARDS CVS DIVISION
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT HAD A TOOTH EXTRACTION ON 09/01/1997 WITH A REDUCTION OF ANTICOAGULANTS BY THE DENTIST. ON THE MORNING OF 09/04/1997, THE PATIENT REPORTED TO THE COUNTY HOSPITAL WITH SYNCOPAL EPISODES, FOLLOWED BY BREATHING DIFFICULTIES. THE PATIENT CONTINUED TO DETERIORATE AND WAS TRANSFERRED TO THE REGIONAL HOSPITAL WHERE SHE WAS INTUBATED AND PLACED ON A RESPERATOR. A TEE WAS PERFORMED LATER THAT EVENING WHICH SHOWED GRADE III MITRAL INSUFFICIENCY. THE PATIENT WAS DEEMED INOPERABLE AND PLACED ON CATECHOLAMINES. ANOTHER TEE WAS PERFORMED THE MORNING OF 09/05/1997 CONFIRMED THE INSUFFICIENCY AGAIN. THE PATIENT DIED LATER THAT EVENING, REPORTEDLY OF NATURAL CAUSES. ON AUTOPSY ON 09/08/1997, HALF OF A LEAFLET WAS NOTED IN THE ILIAC BIFURCATION. NO FURTHER INFORMATION PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H