BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 1884927 · Received October 28, 2010

    Report

    Report Number
    3005099803-2010-04540
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PARTIALLY DEPLOYED BY APPROXIMATELY 73 MM. THE STAINLESS STEEL SHAFT WAS BENT, DISTAL TO THE DISTAL END OF THE PROXIMAL HANDLE. DURING FUNCTIONAL ANALYSIS, IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH BY HAND OR TO RECONSTRAIN THE PARTIALLY DEPLOYED STENT, SO THE SHAFT WAS DISSECTED PROXIMAL TO THE STENT AND THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. THE OUTER SHEATH WAS UNABLE TO BE MOVED PROXIMALLY OR DISTALLY. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT OR THE INNER LUMEN. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUES IS OPERATIONAL CONTEXT. 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 WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A COLONIC STENTING PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD COLON CANCER, AND AS A RESULT PRESENTED WITH A FOUR CENTIMETER STRICTURE LOCATED IN THE SIGMOID COLON. THE ANATOMY WAS REPORTED TO BE TORTUOUS. DURING THE STENTING PROCEDURE, AFTER THE STENT WAS DEPLOYED FIFTY PERCENT OF WAY IT BECAME "STUCK", AND THE PHYSICIAN WAS UNABLE TO FULLY DEPLOY OR RECONSTRAIN THE STENT. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE "STABILIZED".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A COLONIC STENTING PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD COLON CANCER, AND AS A RESULT PRESENTED WITH A FOUR CENTIMETER STRICTURE LOCATED IN THE SIGMOID COLON. THE ANATOMY WAS REPORTED TO BE TORTUOUS. DURING THE STENTING PROCEDURE, AFTER THE STENT WAS DEPLOYED FIFTY PERCENT OF WAY IT BECAME "STUCK", AND THE PHYSICIAN WAS UNABLE TO FULLY DEPLOY OR RECONSTRAIN THE STENT. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE "STABILIZED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - MARLBOROUGH M00565060

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR