BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1180845 · Received September 23, 2008

    Report

    Report Number
    2134265-2008-02766
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    June 25, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT HAD BEEN DEPLOYED AND WAS NOT RETURNED. A WHITE CRYSTALLINE MATERIAL WAS VISIBLE ON THE CATHETER SHAFT INSIDE THE VALVE BODY, THE PROXIMAL CLEAR OUTER SHEATH AND DISTAL TO THE MIDDLE TO DISTAL BOND. THE MATERIAL COULD ALSO BE SEEN PROXIMAL TO THE STENT OUTER BOND. A STRONG RESISTANCE WAS MET WHEN AN ATTEMPT WAS MADE TO RETRACT THE OUTER SHEATH. THIS RESISTANCE WAS MOST PROBABLY DUE TO THE WHITE CRYSTALLINE MATERIAL OBSERVED ON THE DEVICE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT WAS NOT ABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOT REPORTABLE BASED ON THE RETURNED DEVICE ANALYSIS COMPLETED IN 2008. IT WAS REPORTED THAT DURING A CAROTID STENTING TREATMENT PROCEDURE, DEPLOYMENT RESISTANCE WAS ENCOUNTERED. A CAROTID WALLSTENT MONORAIL 10.0-37 HAD BEEN ADVANCED TO AN UNSPECIFIED CAROTID LOCATION. DURING DEPLOYMENT, THE PHYSICIAN ENCOUNTERED RESISTANCE, BUT WAS ABLE TO DEPLOY THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD". THE RETURNED PRODUCT ANALYSIS REVEALED A WHITE CRYSTALLINE MATERIAL ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC 10.0 X 37MM 0011340053

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR