BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2223170 · Received August 12, 2011

    Report

    Report Number
    2953200-2011-01439
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (BACKEND WHEEL). EVAL SUMMARY: THE DEVICE WAS BLOODY. THE STENT GRAFT WAS LOADED IN PLACE. THERE WERE KINKS ON THE SHEATH AT 1.5 AND 6.5CM FROM THE EDGE OF THE GRAFT COVER. THERE WAS A SEVERE KINK AT 10.5CM FROM EDGE OF GRAFT COVER. IT WAS CONFIRMED BY THE FIELD THAT THERE WERE NO KINKS ON THE DEVICE UPON REMOVAL FROM THE PT. THE KINKS WERE DUE TO PACKAGING AND SHIPPING. THE SLIDER WAS IN THE HOME POSITION. THE BACKEND WHEEL AND GRIP HANDLE WERE CONNECTED IN PLACE AT THE BACKEND. THE BACKEND WHEEL WAS 1CM FROM THE BOTTOM END OF THE SCREW GEAR. THE WHEEL APPEARED HALF WAY ON THE SCREW GEAR. THE BACKEND GRIP HANDLE APPEARED OUT OF POSITION. THE GAP BETWEEN THE REAR GRIP AND THE BACKEND REAR GRIP WAS 3.5CM. DURING EVAL, THE BACKEND REAR GRIP HANDLE WAS ADJUSTED FOR A 3.2CM GAP. THE WHEEL WAS ROTATED FORWARD, AND THERE WAS A CORRESPONDING MOVEMENT OF THE TIP WHICH EXTENDED 1.5CM OUT OF THE GRAFT COVER. THE GRAFT DEPLOYED FINE AS NORMAL ON THE TABLE, AND THE SPINDLE RELEASED FINE WITHOUT ISSUES. THE COMPLAINT WAS CONFIRMED, AS THE BACKEND GRIP HANDLE WAS OUT OF POSITION. HOWEVER, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT WAS INSERTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT AFTER THE DELIVERY SYSTEM WAS INSERTED IN THE PT, THE GREY HANDLE BECAME SEPARATED WHEN THE BACKEND WHEEL WAS ROTATED HALFWAY DOWN. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM FROM THE PT AND ELECTED TO USE ANOTHER DEVICE, WHICH SUCCESSFULLY COMPLETED THE PROCEDURE. THE PACKAGING OF THE FIRST DEVICE WAS NOT DAMAGED, AND THERE WAS NO OTHER DAMAGE OR KINKS ON ITS DELIVERY SYSTEM. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE DEVICE HAS BEEN RECEIVED BY MEDTRONIC, AND THE ANALYSIS HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00890060

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK