BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

    MDR report key: 1931524 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05195
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DISTAL END OF THE STENT WAS PARTIALLY DEPLOYED, WITH ONLY ABOUT 20MM STILL CROCHETED ONTO THE DELIVERY SYSTEM. DURING A FUNCTIONAL TEST, THE REMAINDER OF THE STENT COULD NOT BE DEPLOYED. A MICROSCOPIC EXAMINATION FOUND THAT A LOOSE FRAGMENT OF STENT WIRE WAS TANGLED UP WITH THE DEPLOYMENT SUTURE, THUS PREVENTING THE STENT FROM BEING DEPLOYED. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, 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 AN ULTRAFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE ESOPHAGUS ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AFTER THE STENT WAS NEARLY FULLY DEPLOYED, THE DEPLOYMENT SUTURE GOT STUCK ON THE DISTAL END OF THE STENT; THE REMAINDER OF THE STENT COULD NOT BE DEPLOYED. THE PHYSICIAN REMOVED THE DEVICE AND USED ANOTHER ULTRAFLEX STENT TO COMPLETE THE PROCEDURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE ESOPHAGUS ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AFTER THE STENT WAS NEARLY FULLY DEPLOYED, THE DEPLOYMENT SUTURE GOT STUCK ON THE DISTAL END OF THE STENT; THE REMAINDER OF THE STENT COULD NOT BE DEPLOYED. THE PHYSICIAN REMOVED THE DEVICE AND USED ANOTHER ULTRAFLEX STENT TO COMPLETE THE PROCEDURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00514250 0013624447

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR