BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT

    MDR report key: 2191181 · Received July 29, 2011

    Report

    Report Number
    2953200-2011-01353
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA IRELAND
    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

    (B)(4). RESULTS: (ENDOLEAK). RESULTS AND CONCLUSIONS: (AORTIC NECK ANGULATION OF 70-80 DEGREES).

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM, APPROX TWO YEARS AGO. VESSEL MORPHOLOGY WAS REPORTED AS MILD TO MODERATE CALCIFICATION AND TORTUOUSITY; AN AORTIC NECK ANGULATION OF 70-80 DEGREES; AN UNK AORTIC NECK DIAMETER. AT A RECENT FOLLOW-UP VISIT, THE CT SHOWED A PROXIMAL TYPE I ENDOLEAK, WITHOUT MIGRATION. THE PHYSICIAN PLACED AN ENDURANT CUFF AND ANOTHER MFR'S STENT, WHICH CORRECTED THE TYPE I ENDOLEAK. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR SANTA IRELAND NA V00323935

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention