BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 2071755 · Received April 28, 2011

    Report

    Report Number
    3005099803-2011-01551
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE OUTER SHEATH WAS FULLY RETRACTED AND THAT STENT HAD BEEN DEPLOYED. THE STENT WAS NOT RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE DISTAL TIP OF THE INNER SHAFT WAS MISSING. THE INNER SHAFT WAS SEVERELY KINKED ALONG ITS LENGTH DISTAL TO THE STENT HOLDER. THE OUTER SHEATH OF THE DEVICE WAS BROKEN AT APPROXIMATELY 205MM DISTAL TO THE DISTAL HANDLE. THE STAINLESS STEEL SHAFT WAS BENT IN APPEARANCE. THE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF STENT DEPLOYMENT ISSUE (PARTIAL DEPLOYMENT). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    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), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT SYSTEM WAS POSITIONED WITHIN THE COLON. DURING DEPLOYMENT, EXCESSIVE RESISTANCE WAS ENCOUNTERED AND ADDITIONAL FORCE WAS APPLIED IN AN ATTEMPT TO RELEASE THE STENT. WHEN THE STENT WAS PARTIALLY DEPLOYED, A "POP" WAS HEARD AND THE STENT FAILED TO DEPLOY ANY FARTHER. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ON (B)(6), 2011, PRELIMINARY INVESTIGATION RESULTS REVEALED THAT THE STENT AND THE DISTAL TIP OF THE CATHETER WERE NOT RETURNED TO BOSTON SCIENTIFIC. THE SITE WAS QUERIED AND REPORTED THAT THE STENT HAD BEEN DISPOSED OF AND THE SITE WAS UNABLE TO LOCATE THE DISTAL TIP OF THE CATHETER. HOWEVER, THE SITE DID CONFIRM THAT THE DISTAL TIP OF THE CATHETER WAS NOT IN THE PATIENT.

    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) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT SYSTEM WAS POSITIONED WITHIN THE COLON. DURING DEPLOYMENT, EXCESSIVE RESISTANCE WAS ENCOUNTERED AND ADDITIONAL FORCE WAS APPLIED IN AN ATTEMPT TO RELEASE THE STENT. WHEN THE STENT WAS PARTIALLY DEPLOYED, A "POP" WAS HEARD AND THE STENT FAILED TO DEPLOY ANY FARTHER. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    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 - GALWAY M00565050 0013760135

    Patients

    Seq Age Sex Outcome Treatment
    1