BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2032455 · Received March 25, 2011

    Report

    Report Number
    2953200-2011-00706
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (STENT GRAFT THROMBOSIS). CONCLUSIONS: (INFOLDING).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM, TWO MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS AN AORTIC NECK WITH A DIAMETER OF 32MM. IT WAS REPORTED THAT ONE MONTH AFTER IMPLANT THE PROXIMAL PORTION OF THE BIFURCATED STENT GRAFT WAS FOUND TO HAVE INFOLDED AND FORMED INTRAMURAL THROMBUS. THE STENT GRAFT WAS ACCURATELY PLACED BELOW THE RENALS AND THERE WAS NO ENDOLEAK AT THE TIME OF IMPLANT. NO INTERVENTION WAS DONE AND THE PHYSICIAN DECIDED TO ADMINISTER ANTICOAGULANT MEDICATION AND MONITOR THE PT. NO CLINICAL FURTHER 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 V00563761

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention