BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE

    MDR report key: 2143214 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02141
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    April 29, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE STENT WAS FULLY MOUNTED. A TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE NOTED SOME DAMAGE AT APPROXIMATELY 8MM PROXIMAL TO ITS DISTAL EDGE. MICROSCOPIC EXAMINATION OF THE DAMAGE SUGGESTS THAT THE INSIDE OF THE OUTER SHEATH IS SCRATCHED. EXAMINATION OF THE DEPLOYED STENT NOTED THAT SOME OF THE DISTAL STENT WIRES WERE UNCROSSED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY STENT WAS USED DURING A BILIARY STENT PROCEDURE FOR A 60MM MALIGNANT STRICTURE IN THE BILE DUCT, PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS DILATED PRIOR TO THE PROCEDURE. THE PATIENT'S ANATOMY WAS REPORTED AS NORMAL. THE PHYSICIAN REPORTED THAT THE STENT DID NOT OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE STENT WIRES WERE UNCROSSED AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965430600

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR