BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYDRO

    MDR report key: 1062895 · Received June 19, 2008

    Report

    Report Number
    2953200-2008-00447
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    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

    EVAL, RESULTS AND CONCLUSION: INHERENT RISK OF PROCEDURE (ENDOLEAK). (SEVERE DISEASE PROGRESSION WITH THE AORTIC NECK DILATATION AND 90 PERCENT AORTIC NECK ANGULATION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN 8.0 CM ABDOMINAL AORTIC ANEURYSM. THE VESSELS HAVE SEVERE DISEASE PROGRESSION WITH AORTIC NECK DILATATION AND 90 PERCENT AORTIC NECK ANGULATION. IT WAS REPORTED APPROX 75 MONTHS POST STENT GRAFT SYSTEM IMPLANT, THE STENT GRAFT HAD MIGRATED DUE TO A SEVERE ANGULATION OF THE AORTIC NECK (MFR REPORT# 2953200-2008-00363). THE PT WAS TREATED WITH TWO TALENT PROXIMAL EXTENSION CUFFS (MFR REPORT# 2953200-2008-00446) AND THREE ANEURX CUFFS. APPROX A MONTH LATER, THE ENDOLEAK WAS STILL PRESENT AND THE PHYSICIAN ELECTED TO EXPLANT ALL THE STENT GRAFTS CONVERTING THE PT TO AN OPEN SURGICAL CONVERSION. THE DEVICES WERE DISCARDED BY THE USER FACILITY. THE PT WAS REPORTED TO BE FINE AND NO ADDITIONAL CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention