BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1911505 · Received December 1, 2010

    Report

    Report Number
    2134265-2010-05286
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    September 29, 2010
    Report Date
    November 3, 2010
    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

    (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PARTIALLY DEPLOYED BY 15MM. THERE WAS DRIED BLOOD ALONG THE SHAFT AND A BREAK WAS NOTED IN THE OUTER SHEATH AT 3MM DISTAL TO THE SHRINK TUBING. THE SHAFT WAS ALSO KINKED AT THIS LOCATION. THE OUTER SHEATH WAS ACCORDIONED DISTAL TO THE OUTER SHEATH BREAK. DURING ANALYSIS IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH AND FULLY DEPLOY THE STENT DUE TO THE OUTER SHEATH BREAK AND AN ATTEMPT MADE TO RETRACT THE OUTER SHEATH BY HAND FAILED. THE SHAFT WAS DISSECTED PROXIMAL TO THE MONORAIL EXIT AND THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. A SLIGHT RESISTANCE WAS NOTED DURING WITHDRAWAL OF THE INNER LUMEN AND STENT THAT WAS MOST PROBABLY DUE TO THE DRIED BLOOD ALONG THE SHAFT. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT OR THE INNER LUMEN THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT REPORTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A CAROTID ARTERY TREATMENT PROCEDURE STENT DEPLOYMENT DIFFICULTIES OCCURRED. THE 3X20MM, 80-90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT INTERNAL CAROTID ARTERY. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. DURING DEPLOYMENT THE DISTAL PART OF THE STENT DID NOT OPEN. THE PHYSICIAN RE-CONSTRAINED THE PARTIALLY DEPLOYED STENT AND REMOVED IT. THE CASE WAS SUCCESSFULLY COMPLETED WITH A 9X30MM CAROTID WALLSTENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS LISTED AS FINE. ANALYSIS FOUND A SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H965SCH647130 0013734662

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 3X20MM STERLING BALLOON CATHETER| FILTERWIRE EZ| 6FR COOK SHEATH