BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 924768 · Received October 5, 2007

    Report

    Report Number
    6000093-2007-01853
    Event Type
    Malfunction
    Date Received
    October 5, 2007
    Date of Event
    September 6, 2007
    Report Date
    September 6, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    SAME EVENT AS MANUFACTURER'S REPORT #:2954755-2007-00039. IT WAS REPORTED THAT DURING AN INTERNAL CAROTID STENTING PROCEDURE, FILTERWIRE AND STENTING DIFFICULTIES WERE ENCOUNTERED. THE LESION BEING TREATED WAS LOCATED IN THE 85-90% STENOSED INTERNAL CAROTID ARTERY. FOLLOWING ADVANCEMENT OF THE FILTERWIRE, THE LESION WAS PREDILATED WITH A 3 X 30MM STERLING BALLOON. THEN, THE NEXSTENT WAS SUCCESSFULLY DEPLOYED, AND THE DELIVERY DEVICE WAS REMOVED WITHOUT INCIDENT. A 5 X 30MM STERLING BALLOON WAS ADVANCED FOR POSTDILATION, HOWEVER THERE WAS DIFFICULTY CROSSING A PORTION OF THE FILTERWIRE, AND THEY HAD TO "PUSH" THE CATHETER ACROSS THAT AREA. POSTDILATION WAS THEN SUCCESSFULLY COMPLETED. WHILE ATTEMPTING TO WITHDRAW THE STERLING BALLOON, IT KEPT GETTING "HUNG UP" ON THE FILTERWIRE PROXIMAL TO THE NEXSTENT. ATTEMPTS TO MOVE THE BALLOON CATHETER WERE CAUSING THE FILTER BASKET TO MOVE DISTALLY INTO THE INTERNAL CAROTID ARTERY. THE BALLOON CATHETER WAS THEN SUCCESSFULLY REMOVED. A SECOND NEXSTENT WAS SUCCESSFULLY DEPLOYED NEAR THE FIRST ONE, AND THE DELIVERY DEVICE WAS REMOVED WITHOUT INCIDENT. ANOTHER 5 X 30MM STERLING BALLOON WAS ADVANCED, ENCOUNTERING THE SAME DIFFICULTIES CROSSING A REGION OF THE FILTERWIRE. THE SECOND NEXSTENT WAS THEN SUCCESSFULLY POSTDILATED. HOWEVER, THEY AGAIN HAD ISSUES WITHDRAWING THE BALLOON CATHETER ON THE FILTERWIRE WITH THE SAME EFFECT OF THE FILTER BASKET MOVING DISTALLY. FOLLOWING SUCCESSFUL REMOVAL OF THIS CATHETER, ATTEMPTS WERE MADE TO WITHDRAW THE FILTERWIRE, BUT THEY WERE UNABLE TO CAPTURE IT WITH THE RETRIEVAL SHEATH. AN ATTEMPT WAS MADE WITH A BENT TIP RETRIEVAL SHEATH; HOWEVER THAT WAS UNSUCCESSFUL AS WELL. A PINNACLE SHEATH WAS THEN ADVANCED THROUGH THE NEXSTENT, AND THE FILTER BASKET WAS CAPTURED AND WITHDRAWN. EXAMINATION OF THE DEVICES FOLLOWING REMOVAL OF THE ENTIRE SYSTEM SHOWED A ROUGH "SERRATED" EDGE ON THE FILTERWIRE, AND THE NOSECONE OF ONE OF THE NEXSTENT DELIVERY DEVICES WERE SEPARATED AND ATTACHED TO THE FILTERWIRE. NO PORTION OF THE DELIVERY DEVICE WAS LEFT IN THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS REPORTED AS 'FINE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR