BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    MDR report key: 2031343 · Received March 23, 2011

    Report

    Report Number
    2953200-2011-00684
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (MIGRATION, ENDOLEAK), (DISEASE PROGRESSION WITH AORTIC NECK DILATATION). CONCLUSION: (DISEASE PROGRESSION WITH AORTIC NECK DILATATION).

    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 64 MONTHS AGO. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT IS UNK. CURRENTLY THE ANEURYSM HAS INCREASED IN SIZE FROM 5.4 CM AT IMPLANT TO 5.8 CM AT THE TIME OF MIGRATION. THE AORTIC NECK WAS ANGULATED 15 DEGREES AND HAD DILATED FROM 23 MM IN DIAMETER AT THE TIME OF IMPLANT TO 25 MM, DUE TO DISEASE PROGRESSION. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED 15 MM DISTALLY WITH A PROXIMAL TYPE 1 ENDOLEAK. THE PHYSICIAN IMPLANTED A TALENT AORTIC CUFF AND SUCCESSFULLY RESOLVED THE ENDOLEAK AND MIGRATION. NO ADD'L CLINICAL SEQUELAE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 779944

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention