BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANNEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    MDR report key: 1911062 · Received November 24, 2010

    Report

    Report Number
    2953200-2010-02344
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).:EVAL, RESULTS: MIGRATION, ENDOLEAK; LACK OF INFO, UNK CAUSE OF MIGRATION. CONCLUSION: LACK OF INFO, UNK CAUSE OF MIGRATION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 52 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNK. IT WAS REPORTED THAT AT ROUTINE F/U, THE STENT GRAFT WAS FOUND TO HAVE MIGRATED AND IS 2 CM BELOW THE LEVEL OF THE RENAL ARTERIES WITH A PROXIMAL TYPE 1 ENDOLEAK PRESENT. THE NECK MEASURES 23-24 MM IN DIAMETER AND 15 MM DISTALLY IT MEASURES 31 MM IN DIAMETER. THE PT WAS SUCCESSFULLY TREATED WITH ANOTHER MFR'S CUFF ON AN UNK DATE. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANNEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 872516

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention