BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

    MDR report key: 2192711 · Received August 5, 2011

    Report

    Report Number
    3005099803-2011-02655
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX COVERED ESOPHAGEAL STENT WAS IMPLANTED WITHIN THE PATIENT ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD AN ESOPHAGEAL STRICTURE DUE TO CANCER. THE STRICTURE WAS LOCATED FROM 30-34CM IN THE ESOPHAGUS. THE STENT WAS SUCCESSFULLY IMPLANTED ON (B)(6), 2011. ON (B)(6), 2011, THE PATIENT RETURNED TO THE HOSPITAL FOR A FOLLOW-UP VISIT. HOWEVER, ENDOSCOPIC IMAGES SHOWED THAT STENT HAD MIGRATED BY 5CM. THE STENT WAS LEFT IMPLANTED AND THE PHYSICIAN PLACED A SECOND ULTRAFLEX STENT. THE SECOND STENT WAS PLACED FROM 30-40CM IN THE ESOPHAGUS, SLIGHTLY ABOVE THE FIRST STENT. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT 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 M00513750 13987379

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention