BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    MDR report key: 616260 · Received June 22, 2005

    Report

    Report Number
    2953200-2005-01157
    Event Type
    Death
    Date Received
    June 22, 2005
    Date of Event
    May 25, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. IT WAS REPORTED THAT THERE WAS A SMALL TYPE 1 ENDOLEAK PRESENT AT THE END OF THE CASE. THE ONLY BALLOONS AVAILABLE WERE NON COMPLIANT BALLOONS AND THEY WERE NOT LARGE ENOUGH FOR DILATING THE AORTIC NECK AT THE LOCATION OF THE ENDOLEAK; THEREFORE, 2 BALLOONS A 16MM AND A 20 MM BALLOON WERE INSERTED AND PLACED SIDE BY SIDE AND INFLATED. SUBSEQUENTLY THE AORTA WAS RUPTURED ABOVE THE STENT GRAFT FROM THE LEVEL OF THE RIGHT RENAL ARTERY ALL THE WAY TO THE SUPERIOR MESENTERIC ARTERY AND AN ANGIOGRAM SHOWED ACTIVE BLEEDING ON THE LEFT SIDE. THE PATIENT WAS CONVERTED TO SURGICAL OPEN REPAIR AND WAS SENT TO THE RECOVERY ROOM IN A COMPROMISED CONDITION. IT WAS REPORTED THE PATIENT EXPIRED 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA 578822

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death