BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 589351 · Received April 8, 2005

    Report

    Report Number
    2953200-2005-01081
    Event Type
    Death
    Date Received
    April 8, 2005
    Date of Event
    March 10, 2005
    Report Date
    March 10, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PATIENT FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT TIME OF IMPLANT ARE UNKNOWN. THE PATIENT WAS CONSIDERED A HIGH RISK CANDIDATE AT THE TIME OF INITIAL IMPLANT DUE TO PULMONARY, RENAL, AND CARDIAC DISEASE. IT WAS REPORTED THAT 53 MONTHS POST IMPLANT 4 CUFFS WERE ADDED DUE TO DISTAL MIGRATION OF THE PROXIMAL END OF THE GRAFT 8 CM. IT WAS REPORTED THAT 61 MONTHS POST IMPLANT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH PERSISTENT NAUSEA AND VOMITING. THE PATIENT WAS HYPOTENSIVE AND PALE. THE COMPUTED TOMOGRAPHY DEMONSTRATED A RUPTURED 9 CM ABDOMINAL AORTIC ANEURYSM IN THE ANTERIOR WALL. THE PHYSICIAN SURGICALLY REMOVED THE STENT GRAFT AND CONVERTED THE PATIENT TO OPEN SURGICAL REPAIR. THE PHYSICIAN NOTED THAT THERE WERE NO TEARS OR HOLES IN THE STENT GRAFT. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM. FURTHER INFORMATION WAS RECEIVED AND WE WERE INFORMED THAT THE PATIENT HAD EXPIRED ON AN UNKNOWN DATE, AND UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA M9976197

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death