BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT SYSTEM

    MDR report key: 2080598 · Received April 22, 2011

    Report

    Report Number
    2953200-2011-00864
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS/CONCLUSION: (SEVERELY CALCIFIED AORTIC NECK AND ILIAC ARTERIES).

    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 APPROX ONE MONTH AGO. THE ILIAC ARTERIES WERE SEVERELY TORTUOUS AND SEVERELY CALCIFIED. THE AORTIC NECK WAS SEVERELY CALCIFIED, 23 MM IN DIAMETER AT THE LEVEL OF THE RENAL ARTERIES AND 30 MM LONG. THE PT HAD TWO ILIAC BARE METAL STENTS PLACED TWO MONTHS AGO IN PREPARATION FOR THE STENT GRAFT PROCEDURE. IT WAS REPORTED THAT AN ENDURANT BIFURCATED STENT GRAFT ATTEMPTED TO BE INSERTED; HOWEVER, DUE TO THE PREVIOUSLY PLACED ILIAC STENTS, THE DELIVERY CATHETER COULD NOT BE ADVANCED TO THE INTENDED LANDING ZONE. THE DELIVERY CATHETER WAS REMOVED FROM THE PT. THERE WERE NO KINKS NOTED ON THE DELIVERY CATHETER AND IT WAS DISCARDED BY THE USER FACILITY. THE PHYSICIAN INSERTED ANOTHER ENDURANT DELIVERY CATHETER WITH A SMALLER OUTER DIAMETER AND WAS ABLE TO IMPLANT THE STENT GRAFT; HOWEVER, THE SENT GRAFT LANDED LOWER THAN INTENDED. INSERTION OF AN ENDURANT AORTIC CUFF WAS ATTEMPTED, BUT IT WAS NOT POSSIBLE TO ADVANCE IT TO THE INTENDED LOCATION. THE DELIVERY CATHETER WAS REMOVED FROM THE PT AND THERE WERE NO KINKS ON THE DELIVERY CATHETER. THE DELIVERY CATHETER WAS DISCARDED BY THE USER FACILITY. ANOTHER SMALLER DIAMETER ENDURANT AORTIC CUFF WAS ABLE TO BE INSERTED AND DEPLOYED IN THE AREA BETWEEN THE RENAL ARTERY AND THE BIFURCATED STENT GRAFT. 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 BIFURCATED STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00832958

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention