BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM-HYDRO

    MDR report key: 1953484 · Received January 5, 2011

    Report

    Report Number
    2953200-2011-00014
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK). RESULTS/CONCLUSIONS: (CALCIFIED AORTIC NECK).

    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. THE ANEURYSM WAS 5.5 CM IN DIAMETER; THE AORTIC NECK 19 MM IN DIAMETER FOR THE 12 MM IN LENGTH OF THE AORTIC NECK. THE VESSEL MORPHOLOGY WAS REPORTED AS SEVERE CALCIFICATION AND MODERATE TORTUOSITY AND THERE WAS 20 DEGREE ANGULATION IN THE AORTIC NECK. THE STENT GRAFTS WERE IMPLANTED UPON FINAL ANGIOGRAM THERE WAS A PROXIMAL TYPE I ENDOLEAK PRESENT, DUE TO CALCIFICATION IN THE AORTIC NECK. THE PHYSICIAN ELECTED TO IMPLANT AN ANEURX AORTIC CUFF THE ENDOLEAK DECREASED; HOWEVER, DID NOT COMPLETELY RESOLVE. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. 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 GALWAY NA V00526488

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention