BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 475193 · Received August 1, 2003

    Report

    Report Number
    2953161-2003-00041
    Event Type
    Death
    Date Received
    August 1, 2003
    Date of Event
    July 24, 2003
    Report Date
    July 31, 2003
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PRODUCT SPECIALIST PRESENT AT THE CASE, THE BALLOONING OF THE DEVICE RUPTURED THE AORTA THUS THE PT WAS CONVERTED TO AN OPEN PROCEDURE. THE DEVICE DEPLOYED ACCURATELY. HOWEVER, BECAUSE OF THE LOSS OF BLOOD PRESSURE AND THE DISTENSION OF THE ABDOMEN THE CLINICIAN CONVERTED THE PT. THE CLINICIAN IS NOT MAKING AN ALLEGATION AGAINST THE DEVICE BUT DID STATE THAT THE 12FR SHEATH (DAIG) HAD A LIP ON IT THEREFORE WAS DIFFICULT TO ADVANCE. THE PT RECEIVED 10 UNITS OF BLOOD IN ADDITION TO A MINIMUM OF 8 UNITS FROM CELL SAVER. PER THE PRODUCT SPECIALIST'S CONVERSATION WITH VASCULAR SURGEON, THEY DESCRIBED A RIP IN THE ARTERY FROM THE PROXIMAL NECK THROUGH THE RENALS UP FOR 3-4CM. AN "ENDARACTOMY" WAS PERFORMED IN THE PROXIMAL NECK REGION DUE TO THE CALCIUM IN THE REGION. THE SURGEON DESCRIBED THE VESSEL AS FRIABLE. AN AORTO-BIFEMORAL GRAFT WAS PLACED TO BRIDGE THE RUPTURED ANEURYSM. DIFFICULTY IN CREATING A PROXIMAL SEAL WITH THE GRAFT WAS EXPERIENCED. A BOWEL DISSECTION FOLLOWED DUE TO PREVIOUS ISSUES OF THE PT. THE PT. WAS MOVED TO ICU THAT AFTERNOON WITH LOW TO NO URINE OUTPUT. THE PT EXPIRED TWO DAYS LATER AT 8:00PM DUE TO CARDIOGENIC SHOCK BASED ON THE PREVIOUS SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLUDER BIFURCATED ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES,INC WLG325 021160502

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death