BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT DELIVERY SYSTEM WITH XCELERANT

    MDR report key: 1895421 · Received November 4, 2010

    Report

    Report Number
    2953200-2010-02155
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    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

    (B)(4). EVAL RESULTS AND CONCLUSION: MIGRATION, ENDOLEAK. DISEASE PROGRESSION, MODERATE ANGULATION OF THE AORTIC NECK AND TORTUOUS ILIAC ARTERIES.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS SUCCESSFULLY IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM 5 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. CURRENTLY THE VESSEL MORPHOLOGY WAS REPORTED AS THERE IS DISEASE PROGRESSION, MODERATE AORTIC NECK ANGULATION AND TORTUOUS ILIAC ARTERIES. IT WAS REPORTED THAT THE PT PRESENTED FOR A ROUTINE FOLLOW-UP AND THE CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED 5 CM WITH A PROXIMAL TYPE 1 ENDOLEAK. THE PHYSICIAN IMPLANTED 4 PROXIMAL AORTIC CUFFS, TWO 28 MM ANEURX CUFFS AND TWO 30 MM TALENT CUFFS. AFTER LOOKING AT THE ILIAC LIMB ON THE LEFT SIDE IT WAS EXTENDED A 16X5.5 ILIAC LIMB AS A PRECAUTIONARY MEASURE. THERE WAS NO ENDOLEAK DISTALLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT DELIVERY SYSTEM WITH XCELERANT MIH MEDTRONIC CARDIOVASCULAR NA 638353

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention