BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1230190 · Received November 13, 2008

    Report

    Report Number
    2953200-2008-01043
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: SEVERE CALCIFICATION IN THE AORTIC NECK), (ENDOLEAK). CONCLUSION: (SEVERE CALCIFICATION IN THE AORTIC NECK). SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS SEVERELY CALCIFIED. IT WAS REPORTED THE BIFURCATED STENT GRAFT WAS IMPLANTED RIGHT UNDER THE RENAL ARTERY. THE AORTIC NECK WAS 26 MM IN DIAMETER. THE ANGIOGRAM REVEALED A TYPE I ENDOLEAK WHICH WAS DUE TO THE SEVERE CALCIFICATION IN THE AORTIC NECK. THE PHYSICIAN BALLOONED THREE TIMES WITH A RELIANT BALLOON, THE TYPE I ENDOLEAK IMPROVED WITH EACH INFLATION, HOWEVER, THE ENDOLEAK DID NOT COMPLETELY RESOLVE. THE PHYSICIAN PLACED ANOTHER MANUFACTURER'S STENT AND THE ENDOLEAK RESOLVED. NO ADDITIONAL 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 - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00117275

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention