BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 614605 · Received June 16, 2005

    Report

    Report Number
    2953200-2005-01151
    Event Type
    Death
    Date Received
    June 16, 2005
    Date of Event
    October 17, 2003
    Report Date
    May 17, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 13.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT ITS COMPONENTS WERE IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT THE STENT GRAFT WAS SUCCESSFULLY PLACED. IT WAS REPORTED TWO DAYS POST STENT GRAFT IMPLANTATION IT WAS REPORTED THE PT TO HAVE PRESENTED TO THE EMERGENCY ROOM FOR RESPIRATORY DISTRESS AND AN ENDOTRACHEAL TUBE WAS INSERTED IN THE PT. THE PT WAS TAKEN TO SURGERY AND A PERFORATED PYLORIC ULCER WAS FOUND AND TREATED. THE PT CONTINUED TO HAVE MECHANICAL VENTILATION FOR FOUR DAYS. THE PT ALSO HAD MULTIPLE INTR-ABDOMINAL ABSCESSES. IT WAS REPORTED IN THE MEDICAL RECORDS THAT THE PT WAS DIAGNOSED WITH SEPSIS AND RESPIRATORY FAILURE FOLLOWING ABDOMINAL SURGERY FOR A GASTRIC PERFORATED ULCER. IT WAS REPORTED THE PT EXPIRED FOUR MONTHS POST STENT GRAFT IMPLANT. THE DEATH CERTIFICATE STATES THE CAUSE OF DEATH WAS DUE TO SEPSIS, WHICH THE ONSET WAS FOR ONE MONTH PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA M03D551749

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death