BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 2130013 · Received June 10, 2011

    Report

    Report Number
    2953200-2011-01115
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (OCCLUSION), (SEVERE TORTUOSITY IN THE VESSEL WITH LOW BLOOD FLOW). EVAL, CONCLUSION: (SEVERE TORTUOSITY IN THE VESSEL WITH LOW BLOOD FLOW).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 43 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PT PRESENTED SYMPTOMATICALLY ONE MONTH AGO WITH AN OCCLUDED IN THE LEFT LIMB. THE CT DEMONSTRATED THAT THERE WAS A KINK IN THE STENT GRAFTS AT THE JUNCTION OF THE BIFURCATED STENT GRAFT STUB AND THE CONTRALATERAL ILIAC LIMB (REF MFR# 2953200-2011-01117 AND 2953200-2011-01116). A THROMBECTOMY WAS PERFORMED, FOLLOWED BY PLACING A PALMAZ STENT. THE OCCLUSION WAS RESOLVED. THE CAUSE OF THE KINK AND OCCLUSION WAS REPORTED DUE TO SEVERE TORTUOSITY IN THE VESSEL WITH LOW BLOOD FLOW. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00034815

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention