BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2091647 · Received April 29, 2011

    Report

    Report Number
    2953200-2011-00908
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK). RESULTS/CONCLUSIONS: (DISEASE PROGRESSION OF THE AORTIC NECK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF A 6.6 CM ABDOMINAL AORTIC ANEURYSM APPROX 94 MONTHS AGO. THE AORTIC NECK DIAMETER WAS 30 MM AND IT WAS 20 MM LONG. IT WAS REPORTED THAT APPROX TWO YRS AGO THE PT RETURNED WITH STENT GRAFT MIGRATION RESULTING IN A TYPE I ENDOLEAK (REF MFR # 2953200-2011-00905). THE PT WAS SUCCESSFULLY TREATED WITH 3 ANEURX AORTIC CUFFS AND A TALENT AORTIC CUFF. APPROX ONE MONTH AGO, IT WAS REPORTED THAT THERE WAS SEPARATION BETWEEN THE BIFURCATED STENT GRAFT AND ANEURX AORTIC CUFF RESULTING IN A TYPE III ENDOLEAK (REF MFR # 2953200-2011-00906, 2953200-2011-00907). THE CUFF SEPARATION WAS ATTRIBUTED TO DISEASE PROGRESSION RESULTING IN ANEURYSM GROWTH. THE DECISION WAS MADE TO TREAT THE PT WITH A TALENT CONVERTER AT A LATER DATE. NO ADD'L CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00167451

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention