BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2030429 · Received March 18, 2011

    Report

    Report Number
    2953200-2011-00681
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (ARTERIAL VENOUS OCCLUSION). EVALUATION RESULTS/CONCLUSION: (SMALL EXTERNAL ILIACS).

    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 APPROX TWO MONTHS AGO. VESSEL MORPHOLOGY WAS NOT REPORTED. THE PT HAD POOR OUTFLOW DUE TO VERY SMALL EXTERNAL ILIAC ARTERIES. IT WAS REPORTED THAT THE PT PRESENTED 34 DAYS LATER WITH AN OCCLUSION OF THE LEFT (IPSILATERAL) STENT GRAFT LIMB. THE PT WAS TAKEN TO THE OPERATING ROOM WHERE A LARGE AMOUNT OF PLAQUE WAS DISCOVERED. A THROMBECTOMY AND AN ENDARTERECTOMY OF THE LEFT SIDE WERE PERFORMED. THIS WAS FOLLOWED BY IMPLANT OF A 10 X 60 STENT FROM ANOTHER MFR. BLOOD FLOW WAS RESTORED AND THE PT HAD GOOD PULSES. NO ADD'L 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 V00795670

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention