BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE HDM) WITH XPEDIENT

    MDR report key: 1895331 · Received November 2, 2010

    Report

    Report Number
    2953200-2010-02110
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 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 & CONCLUSION: (DISEASE PROGRESSION WITH AORTIC NECK DILATATION). EVAL, RESULTS: (MIGRATION, ENDOLEAK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYS WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 67 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNK. CURRENTLY, THE ANEURYSM IS 5.75 CM IN DIAMETER, THE AORTIC NECK IS 1 CM IN LENGTH AND IT IS 32 MM IN DIAMETER. THE DISTAL END OF THE STENT GRAFT IS JUST ABOVE THE HYPOGASTRIC ARTERY ON THE RIGHT AND ON THE LEFT IT IS 3 MM FROM THE HYPOGASTRIC ARTERY. THERE IS DISEASE PROGRESSION WITH AORTIC NECK DILATATION AS THE AORTIC NECK RAPIDLY EXPANDED JUST PROXIMAL TO THE ANEURYSM SAC. IT WAS REPORTED THAT DURING REGULAR F/U, THE CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED 30 MM DISTAL OF THE RENAL ARTERIES WITH A TYPE 1 ENDOLEAK PRESENT. THE PT WAS NOT SYMPTOMATIC. THE PT WILL BE TREATED WITHIN A COUPLE WEEKS. 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 (FLEXIBLE HDM) WITH XPEDIENT MIH MEDTRONIC CARDIOVASCULAR NA 387696

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention