BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 2130009 · Received June 16, 2011

    Report

    Report Number
    2134265-2011-02519
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED PARTIALLY DEPLOYED BY APPROXIMATELY 17MM AND THE DISTAL HANDLE WAS FULLY RETRACTED. A FILTERWIRE WAS RETURNED INSERTED THROUGH THE DEVICE. A VISUAL EXAMINATION OF THE OUTER SHEATH NOTED A BREAK AT APPROXIMATELY 290 MM PROXIMAL TO THE DISTAL END OF THE OUTER SHEATH. FURTHER DAMAGE WAS NOTED AT THE DISTAL END OF THE PROXIMAL SECTION OF THE BREAK. DURING ANALYSIS, IT WAS NOT POSSIBLE TO DEPLOY THE STENT DUE TO THE BREAK IN THE OUTER SHEATH. THE DISTAL END OF THE OUTER SHEATH WAS RETRACTED BY HAND AND THE STENT WAS DEPLOYED. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT. IT WAS NOTED THAT THE FILTERWIRE HAD NOT EXITED THE MONORAIL EXIT BUT HAD EXITED MORE PROXIMALLY AT THE OUTER SHEATH BREAK SITE. THIS INDICATES THAT THE FILTERWIRE MAY HAVE BEEN FORCED THROUGH THE OUTER SHEATH WHICH RESULTED IN THE DAMAGE PRESENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID STENTING PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED. USING THE FEMORAL APPROACH, THE PROCEDURE TREATED THE DE NOVO AND ECCENTRIC 70% STENOSED, 5.0X15MM TARGET LESION LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS CAROTID ARTERY. AN 8.0X21MM CAROTID WALLSTENT WAS ADVANCED TO THE TARGET LESION BUT WAS ONLY PARTIALLY DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT IN A PARTIALLY DEPLOYED STATE BECAUSE THE PHYSICIAN COULD NOT RESTRAIN IT. THE PROCEDURE WAS COMPLETED WITH A 7.0X30MM CAROTID WALLSTENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID STENTING PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED. USING THE FEMORAL APPROACH, THE PROCEDURE TREATED THE DE NOVO AND ECCENTRIC 70% STENOSED, 5.0X15MM TARGET LESION LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS CAROTID ARTERY. AN 8.0X21MM CAROTID WALLSTENT WAS ADVANCED TO THE TARGET LESION BUT WAS ONLY PARTIALLY DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT IN A PARTIALLY DEPLOYED STATE BECAUSE THE PHYSICIAN COULD NOT RESTRAIN IT. THE PROCEDURE WAS COMPLETED WITH A 7.0X30MM CAROTID WALLSTENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H965SCH647070 14299705

    Patients

    Seq Age Sex Outcome Treatment
    1