BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1161315 · Received September 11, 2008

    Report

    Report Number
    2134265-2008-02606
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    February 20, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED. IT WAS NOTED THAT THE TIP WAS DETACHED AND WAS NOT RETURNED. THE VALVE BODY HAD BEEN FULLY RETRACTED AND A BREAK WAS NOTED IN THE OUTER SHEATH AT 76MM PROXIMAL, TO THE PROXIMAL, TO MIDDLE BOND. ANOTHER SECTION OF THE OUTER SHEATH MEASURING 2MM HAD DETACHED PROXIMAL TO THE OUTER SHEATH BREAK. THE STIFFENING WIRE WAS KINKED AT 23MM DISTAL TO THE DISTAL END OF THE STAINLESS STEEL SHAFT AND THE SHAFT WAS KINKED 20MM PROXIMAL TO THE MONORAIL EXIT. DUE TO THE CONDITION OF RETURNED DEVICE, IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH AND DEPLOY THE STENT. A REVIEW OF MFG DOCUMENTATION FOR THIS BATCH NUMBER FOUND THAT THE DEVICE MET ITS MATERIAL ASSEMBLY AND PRODUCT SPECS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, WHICH LIMITED THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    EVENT DETERMINED TO BE REPORTABLE BASED ON ANALYSIS: IT WAS REPORTED THAT DURING A CAROTID ANGIOPLASTY PROCEDURE, A SHAFT BREAK OCCURRED. THE LESION WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. THE PERCENT OF THE STENOSIS OF THE LESION, DEGREE OF CALCIFICATION, AND VESSEL TORTUOSITY ARE UNK. THE CAROTID WALLSTENT MONORAIL 10MM X 24MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, HOWEVER, AT AN UNSPECIFIED TIME, THE SDS WAS UNABLE TO MOVE, AND THE SHAFT BROKE AT THE HUB. ALL PIECES OF THE DEVICE WERE REMOVED FROM THE PT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "STABLE". DEVICE ANALYSIS REVEALED A TIP DETACHMENT, SHAFT BREAK AND KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC 10.0 X 24MM 8974654

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR