BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2051275 · Received April 6, 2011

    Report

    Report Number
    2953200-2011-00771
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULT: (ARTERIAL OCCLUSION). RESULT AND CONCLUSION: (MODERATE NECK ANGULATION).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 55 MM DIAMETER ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2011. THE AORTIC NECK HAD MODERATE NECK ANGULATION. THE VESSELS HAD MILD TO MODERATE CALCIFICATION. IT WAS REPORTED THAT TWO DAYS POST STENT GRAFT IMPLANT, THE PT HAD ABDOMINAL PAIN. A CT WAS DONE AND DEMONSTRATED THAT THE STENT GRAFT WAS PARTIALLY COVERING ONE OF THE RENAL ARTERIES. THE PHYSICIAN BELIEVES THAT AT THE TIME OF IMPLANT, THE STENT GRAFT MAY HAVE BEEN DEPLOYED HIGHER THAN INTENDED; HOWEVER, IT WAS NOT NOTED AT THE TIME OF IMPLANT. THE PT IS ON DIALYSIS AND THE CREATININE LEVEL IS DROPPING. THE PT WAS TAKEN OFF DIALYSIS. NO FURTHER INTERVENTION WAS PERFORMED 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 V00814993

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention