BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX? ESOPHAGEAL NG

    MDR report key: 3203108 · Received July 2, 2013

    Report

    Report Number
    3005099803-2013-05863
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU)/PRODUCT LABEL. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. THE DFU STATES "THE ULTRAFLEX COVERED AND UNCOVERED ESOPHAGEAL AND ESOPHAGEAL NG STENT SYSTEM IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS ONLY". HOWEVER, THE COMPLAINT STATES THAT THE STENT WAS ATTEMPTED TO BE IMPLANTED IN THE "ESOPHAGUS-DUODENUM" AS THE PATIENT¿S STOMACH HAD BEEN REMOVED DUE TO CANCER AND THE ESOPHAGUS WAS CONNECTED WITH THE DUODENUM. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE PROXIMAL END OF THE STENT WAS PARTIALLY DEPLOYED BY APPROXIMATELY 90 MM. DURING ANALYSIS, IT WAS POSSIBLE TO RETRACT THE REMAINDER OF THE DEPLOYMENT SUTURE THREAD AND DEPLOY THE STENT WITHOUT ANY ISSUE. NO ISSUES WERE NOTED WITH THE DEPLOYED STENT OR THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER / USE ERROR.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX PROXIMAL RELEASE ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE ESOPHAGUS-DUODENUM OF A PATIENT ON (B)(6) 2013 DURING A STENT IMPLANTATION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING IMPLANTED TO TREAT A STENOSIS DUE TO CANCER. THE PATIENT'S ANATOMY WAS TORTUOUS, AND HAD NOT BEEN DILATED PRIOR TO THE STENT PLACEMENT. IT WAS REPORTED THAT THE PATIENT¿S STOMACH HAD BEEN REMOVED (DATE UNKNOWN) DUE TO CANCER AND THE ESOPHAGUS WAS CONNECTED WITH THE DUODENUM. ALSO THE PATIENT WAS NOTED AS BEING ¿A SERIOUS SICK PATIENT.¿ DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, ONLY A FEW CENTIMETERS OF THE PROXIMAL END COULD BE RELEASED. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. PLEASE NOTE: PER THE DFU, THE ULTRAFLEX ESOPHAGEAL STENT SYSTEM AND THE ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM ARE CONTRAINDICATED FOR PLACEMENT IN AN ESOPHAGO-JEJUNOSTOMY (FOLLOWING GASTRECTOMY), AS PERISTALSIS MAY DISPLACE STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX PROXIMAL RELEASE ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE ESOPHAGUS-DUODENUM OF A PATIENT ON (B)(6) 2013 DURING A STENT IMPLANTATION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING IMPLANTED TO TREAT A STENOSIS DUE TO CANCER. THE PATIENT'S ANATOMY WAS TORTUOUS, AND HAD NOT BEEN DILATED PRIOR TO THE STENT PLACEMENT. IT WAS REPORTED THAT THE PATIENT¿S STOMACH HAD BEEN REMOVED (DATE UNKNOWN) DUE TO CANCER AND THE ESOPHAGUS WAS CONNECTED WITH THE DUODENUM. ALSO THE PATIENT WAS NOTED AS BEING ¿A SERIOUS SICK PATIENT¿ DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, ONLY A FEW CENTIMETERS OF THE PROXIMAL END COULD BE RELEASED. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. PLEASE NOTE: PER THE DFU, THE ULTRAFLEX ESOPHAGEAL STENT SYSTEM AND THE ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM ARE CONTRAINDICATED FOR PLACEMENT IN AN ESOPHAGO-JEJUNOSTOMY (FOLLOWING GASTRECTOMY), AS PERISTALSIS MAY DISPLACE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302698 ULTRAFLEX? ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513840 15251010

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR