BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYDRO

    MDR report key: 1053069 · Received May 23, 2008

    Report

    Report Number
    2953200-2008-00360
    Event Type
    Death
    Date Received
    May 23, 2008
    Date of Event
    April 20, 2008
    Report Date
    April 25, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (DEATH, OCCLUSION). (SEVERELY DISEASED, MODERATELY TORTUOSITY AND MODERATELY CALCIFICATION IN THE VESSELS). CONCLUSION: (SEVERELY DISEASED, MODERATELY TORTUOSITY AND MODERATELY CALCIFICATION IN THE VESSELS). SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD SEVERELY DISEASED, MODERATELY TORTUOSITY AND MODERATELY CALCIFICATION IN THE VESSELS. IT WAS REPORTED 30 DAYS POST STENT GRAFT IMPLANT, THE PATIENT PRESENTED WITH LEFT LEG PAIN. THE CT DEMONSTRATED THAT THERE MAY HAVE BEEN A NARROWING IN THE DISTAL AORTIC BIFURCATION/LEFT ILIAC EXTENSION. THE PHYSICIAN ELECTED TO REMOVE THE THROMBOSIS FROM DISTAL AORTIC BIFURCATION/LEFT ILIAC EXTENSION. THE PHYSICIAN ALSO PERFORMED A KISSING BALLOON PROCEDURE OPENING BOTH ILIAC LIMBS. THE FINAL ANGIOGRAM REVEALED THAT THERE WAS ALSO A TOTAL OCCLUSION OF THE VESSEL BELOW THE KNEE. THE PHYSICIAN THAN REMOVED THE THROMBOSIS FROM BELOW THE KNEE. THERE WAS GOOD BLOOD FLOW TO THE LOWER EXTREMITIES. IT WAS REPORTED THAT THE FOLLOWING DAY THE PATIENT EXPIRED. THE AUTOPSY REPORT IS INCONCLUSIVE, HOWEVER, THE PHYSICIAN BELIEVES THAT THE PATIENT HAD PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00080095

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death