BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1801286 · Received August 11, 2010

    Report

    Report Number
    2953200-2010-01526
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    June 13, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS AND CONCLUSIONS: THROMBOSIS. ANOTHER MANUFACTURER'S GUIDEWIRE.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT AORTIC CUFF WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 3 MONTHS AGO. THE VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS MILD TORTUOUS AND MILDLY CALCIFIED. THERE WAS SOME THROMBOSIS IN THE 3 CM IN LENGTH AORTIC NECK PRIOR TO STENT GRAFT IMPLANT. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THERE MAY HAVE BEEN A DISSECTION IN THE LEFT EXTERNAL ILIAC AT THE TIME OF IMPLANT WHICH WAS RELATED TO ANOTHER MANUFACTURER'S GUIDEWIRE. THE DISSECTION MOST LIKELY PREVENTING BLOOD OUTFLOW FROM THE CONTRALATERAL LEFT ILIAC LIMB. THE PATIENT PRESENTED WITH A COLD LEG AND THE CT DEMONSTRATED THAT THE LEFT ILIAC LIMB WAS TOTALLY OCCLUDED. THE PHYSICIAN ELECTED TO PERFORM A FEMORAL TO FEMORAL BYPASS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00121378

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention