BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID WALLSTENT?

    MDR report key: 3243529 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-05050
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED ON TO THE STENT DELIVERY SYSTEM. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEVICE. DURING ANALYSIS WHEN A 0.014 INCH FILTERWIRE WAS INSERTED THROUGH THE DEVICE IT EXITED THE MONORAIL EXIT AS REQUIRED. SEVERAL FURTHER ATTEMPTS WERE MADE WITH SLIGHT ROTATION OF THE SHAFT AND INTERMITTENTLY THE FILTERWIRE WOULD MEET A RESTRICTION AT THE INNER BATH TUB STAMP OR EXIT THE MONORAIL EXIT AS REQUIRED. DURING ANALYSIS THE STENT WAS DEPLOYED AND NO ISSUES WERE NOTED WITH THE PROFILE OF THE STENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. AS THE 10.0X31MM CAROTID WALLSTENT WAS PREPPED FOR USE, THE PHYSICIAN WAS UNABLE TO LOAD THE WIRE THOUGH THE MONORAIL PORT AND IT WAS NOTED THAT A STENT STRUT WAS STICKING OUT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. AS THE 10.0X31MM CAROTID WALLSTENT WAS PREPPED FOR USE, THE PHYSICIAN WAS UNABLE TO LOAD THE WIRE THOUGH THE MONORAIL PORT AND IT WAS NOTED THAT A STENT STRUT WAS STICKING OUT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342455 CAROTID WALLSTENT? STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H965SCH647130 13712217

    Patients

    Seq Age Sex Outcome Treatment
    1