BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 831200 · Received March 22, 2007

    Report

    Report Number
    6000093-2007-00611
    Event Type
    Injury
    Date Received
    March 22, 2007
    Date of Event
    February 21, 2007
    Report Date
    February 21, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIM
    PMA / PMN Number
    p050025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS RETAINED THIS PRODUCT INDEFINITELY, CONSEQUENTLY, A RETURNED PRODUCT ANALYSIS WILL NOT BE POSSIBLE. THE ROOT CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SAME CASE MANUFACTURER'S REPORT # 2954755-2007-00024. IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE FILTERWIRE BECAME CAUGHT ON THE STENT, REQUIRING SURGICAL INTERVENTION. THE CUSTOMER STATED THAT, "THE STENT WAS DEPLOYED SUCCESSFULLY INTOT HE RIGHT CAROTID ARTERY. WHEN THEY WENT BACK TO POST-DILATE THE LESION, THEY WERE UNABLE TO GET ANYTHING TO CROSS THE LESION. THE PATIENT WAS TAKEN TO SURGERY DUE TO THE FILTERWIRE REMAINING IN THE CAROTID ARTERY. THEY WERE UNABLE TO REMOVE IT AS IT GOT HUNG UP ON THE STENT. THEY BELIEVE THE WIRE AND THE STENT SOME HOW BECAME ENTANGLED." IT WAS FURTHER REPORTED THAT THE LESION WAS LOCATED AT THE RIGHT CAROTID ARTERY BIFURCATION. THE COMMON CAROTID ARTERY WAS 6.7MM IN DIAMETER AND THE INTERNAL CAROTID ARTERY WAS 4.5MM IN DIAMETER. THE VERY MILDLY CALCIFIED LESION LENGTH WAS 15MM AND WAS 85% STENOTIC. THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS. THE VASCULAR ACCESS SITE WAS THE RIGHT COMMON FEMORAL ARTERY. THE SYSTEM WAS CONTINUOUSLY FLUSHED THROUGH A CLOSED MANIFOLD VIA MANUAL INJECTION AND POWER INJECTOR. FLUOROSCOPIC IMAGING USED DURING THE PROCEDURE, BUT IVUS WAS NOT USED. THE PHYSICIAN PRE-DILATED THE LESION WITH A SINGLE BALLOON INFLATION TO 6 ATMS FOR 20 SECONDS. THE INITIAL CROSSING OF THE LESION WITH THE FILTERWIRE WAS EASY AND SUCCESSFUL. THE USER ENCOUNTERED SIGNIFICANT RESISTANCE ONLY AFTER THE STENT WOULD NO LONGER LET BALLOONS CROSS. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF THE EVENT. FOLLOWING SURGICAL REMOVAL OF THE FILTERWIRE AND STENT, THE DEVICES WERE EXAMINED IN THE FACILITY PATHOLOGY LAB. THE FACILITY REPORTED THAT, "THE WIRE RAN THROUGH THE STENT AND THEN THROUGH THE "CROSSHATCHES" OF THE STENT MESH TOWARDS ONE END. AFTER MANIPULATION OF THE DEVICE, THE TWO COMPONENTS HAVE SEPARATED." THE PATIENT'S CURRENT STATUS IS REPORTED AS "DOING FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC CORP. NA C70104

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 4X40MM STERLING BALLOON| COOK 6FR SHUTTLE SHEATH