BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX UNK

    MDR report key: 868966 · Received June 22, 2007

    Report

    Report Number
    2953200-2007-00264
    Event Type
    Death
    Date Received
    June 22, 2007
    Date of Event
    October 31, 2006
    Report Date
    May 30, 2007
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PT HAD A RIGHT ILIAC OCCLUSION WITH CLAUDICATION STATUS POST PREVIOUS ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. THERE WAS EXTERNAL ILIAC STENOSIS WITH TORTUOUSITY THAT APPEARED TO BE THE ETIOLOGY OF THE OCCLUSION. THE LIMB WAS STILL PATENT WITH FLOW INTO THE INTERNAL ILIAC ON THE RIGHT SIDE. THE LEFT EXTERNAL ILIAC ALSO SHOWED FAIRLY SEVERE STENOSIS. RECANNULIZATION WITH THROMBECTOMY OF THE RIGHT ILIAC ARTERY WITH ANGIOPLASTY OF THE EXTERNAL ILIAC ARTERY WAS PERFORMED. TWO STENTS WERE ALSO IMPLANTED. APPROXIMATELY 3 WEEKS LATER, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX UNK MIH MEDTRONIC VASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| R