BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT EXTENSION CUFF STENT GRAFT

    MDR report key: 2172560 · Received July 20, 2011

    Report

    Report Number
    2953200-2011-01302
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (OCCLUSION); (TORTUOUS ILIACS). CONCLUSION: (TORTUOUS ILIACS).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A GREATER THAN 9 CM ABDOMINAL AORTIC ANEURYSM, APPROX FIVE MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS ACUTE ANGULATION OF NECK AND ILIACS. IT WAS REPORTED THAT THE PT HAD AN OCCLUDED LEFT ILIAC; HOWEVER, THE GRAFT WAS OPEN AND THE OCCLUSION WAS DISTAL TO THE ILIAC STENT GRAFT LIMB. ONE MONTH AGO THERE WAS ACUTE LEFT ILIO-FEMORAL THROMBOSIS. THE PT WAS TAKEN TO THE OPERATING ROOM AND THE UNDERLYING FEMORAL ARTERY WAS OPENED LONGITUDINALLY. A LARGE AMOUNT OF ORGANIZED THROMBUS WAS EVIDENT. A # 5 FOGARTY CATHETER WAS PASSED PROXIMALLY AND COPIOUS AMOUNTS OF CLOT WERE REMOVED AND ADEQUATE INFLOW PRESSURE RESUMED. TWO PASSES WITH THE FOGARTY CATHETER WERE MADE AND ON THE SECOND, NO FURTHER CLOT WAS REMOVED. SEVERAL MORE PASSES WERE MADE TO ENSURE ALL CLOT WAS REMOVED. THE FOOT APPEARED WARM WITH ADEQUATE CAPILLARY REFILL. TWO DAYS LATER, A SLIGHT KINK WAS NOTED IN THE DISTAL LIMB OF THE LEFT ILIAC ENDOGRAFT SEGMENT; HOWEVER, IT DID NOT APPEAR TO BE IN ANY WAY FLOW-LIMITING OR SIGNIFICANT. THERE WAS VERY GOOD FLOW INTO THE LEFT ILIO-FEMORAL SYSTEM. INTERNAL REVIEW OF PRE-IMPLANT FILMS SHOWS TORTUOUS ILIACS WHICH MAY HAVE CONTRIBUTED TO THE OCCLUSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT EXTENSION CUFF STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00561220

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention