BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 1895345 · Received November 2, 2010

    Report

    Report Number
    2953200-2010-02111
    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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS AND CONCLUSION: MIGRATION. 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. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNK. CURRENT VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK DIAMETER IS 27-28 MM IN DIAMETER, IT WAS ANGULATED AT LESS THAN 45 DEGREES, AND DISTALLY THE STENT GRAFT IS JUST ABOVE THE HYPOGASTRIC ARTERIES BILATERALLY. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED ABOUT 25-40 MM DISTALLY, WITH NO ENDOLEAKS. THE MIGRATION WAS ATTRIBUTED TO NECK DILATATION. THE PHYSICIAN ELECTED TO IMPLANT A TALENT THORACIC CUFF, BECAUSE A LONGER LENGTH WAS REQUIRED TO BUILD THE DEVICE UP TO THE LEVEL OF THE RENAL ARTERIES. 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) WITH XPEDIENT MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention