BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2113757 · Received June 2, 2011

    Report

    Report Number
    2953200-2011-01068
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (OCCLUSION), (LACK OF INFORMATION, UNK CAUSE OF OCCLUSION). CONCLUSION: (LACK OF INFORMATION, UNK CAUSE OF OCCLUSION ).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT AT A F/U CT DEMONSTRATED THAT THE LEFT ILIAC LIMB WAS OCCLUDED. ONE MONTH AGO THE PHYSICIAN IMPLANTED A BALLOON EXPANDABLE STENT INTO THE GRAFT AND RESTORED THE BLOOD FLOW THROUGH THE VESSELS. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention