BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2050882 · Received April 1, 2011

    Report

    Report Number
    2953200-2011-00731
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    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). RESULTS: STENT GRAFT MISPLACEMENT. RESULTS AND CONCLUSIONS: MODERATE TORTUOSITY. STENT GRAFT MISPLACEMENT.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.6 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS MODERATE TORTUOSITY, WITH NO CALCIFICATION. IT WAS REPORTED THAT THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED; HOWEVER, DURING REMOVAL, THE DELIVERY SYSTEM GOT CAUGHT ON THE SUPRARENAL STENT WHICH MOVED IT DOWN INTO THE PROXIMAL END OF THE AORTIC NECK. A PROXIMAL CUFF WAS THEN IMPLANTED, AND BALLOONED, WHICH PROVIDED ACCEPTABLE COVERAGE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00830232

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention