BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ ESOPHAGEAL NG

    MDR report key: 2250743 · Received September 16, 2011

    Report

    Report Number
    3005099803-2011-03096
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE DEPLOYED STENT WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT COVER WAS DISINTEGRATED. IN ADDITION, THE STENT HAD BEEN TURNED INSIDE OUT, MOST LIKELY UPON REMOVAL FROM THE PATIENT'S BODY. A LABELING REVIEW IDENTIFIED THAT THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. 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. THE ULTRAFLEX ESOPHAGEAL STENT SYSTEM AND THE ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM ARE CONTRAINDICATED FOR ANY USE OTHER THAN THOSE SPECIFICALLY OUTLINED UNDER INDICATIONS FOR USE." HOWEVER, THE COMPLAINT STATES THAT THE STENT WAS PLACED WITHIN THE DUODENUM. IN ADDITION, THE DFU STATES "WARNING: THE ULTRAFLEX ESOPHAGEAL STENT SYSTEM IS NOT INTENDED TO BE MOVED OR REMOVED ONCE IT IS DEPLOYED. MOVING THE DEPLOYED STENT MAY BREAK THE STENT WIRE OR DISLODGE THE COVER." HOWEVER, THE COMPLAINT STATES THAT THE STENT WAS REMOVED DURING A PLANNED STENT REMOVAL PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER/USE ERROR.

    Additional Manufacturer Narrative · 1

    THE IMPLANTATION DATE WAS REPORTED AS APPROXIMATELY 3 WEEKS PRIOR TO (B)(6), 2011. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL COVERED STENT WAS IMPLANTED APPROXIMATELY THREE WEEKS PRIOR TO (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A FISTULA WITHIN THE FIRST PORTION OF THE DUODENUM. IT IS UNKNOWN IF THE FISTULA WAS ASSOCIATED WITH A MALIGNANCY. THE STENT WAS PLACED TO SEAL THE FISTULA. THE PHYSICIAN PLACED AN ESOPHAGEAL STENT WITH THE DUODENUM BECAUSE THE PHYSICIAN WANTED A COVERED STENT TO BETTER SEAL THE FISTULA. ON (B)(6), 2011, THE PATIENT RETURNED FOR A PLANNED STENT REMOVAL PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT TISSUE INGROWTH WAS PRESENT THROUGH THE STENT COVERING IN MULTIPLE PLACES AND THE STENT COVERING HAD DISINTEGRATED. THE STENT WAS REMOVED SUCCESSFULLY. THE PHYSICIAN NOTED THAT THE FISTULA WAS HEALED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE." NOTE: FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU). THE DFU STATE THE ULTRAFLEX ESOPHAGEAL STENT SYSTEM IS "INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS ONLY... AND INDICATED FOR OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULA." HOWEVER, ACCORDING TO THE COMPLAINANT, THE STENT WAS PLACED WITHIN THE DUODENUM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL COVERED STENT WAS IMPLANTED APPROXIMATELY THREE WEEKS PRIOR TO (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A FISTULA WITHIN THE FIRST PORTION OF THE DUODENUM. IT IS UNKNOWN IF THE FISTULA WAS ASSOCIATED WITH A MALIGNANCY. THE STENT WAS PLACED TO SEAL THE FISTULA. THE PHYSICIAN PLACED AN ESOPHAGEAL STENT WITH THE DUODENUM BECAUSE THE PHYSICIAN WANTED A COVERED STENT TO BETTER SEAL THE FISTULA. ON (B)(6), 2011, THE PATIENT RETURNED FOR A PLANNED STENT REMOVAL PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT TISSUE INGROWTH WAS PRESENT THROUGH THE STENT COVERING IN MULTIPLE PLACES AND THE STENT COVERING HAD DISINTEGRATED. THE STENT WAS REMOVED SUCCESSFULLY. THE PHYSICIAN NOTED THAT THE FISTULA WAS HEALED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE." NOTE: FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU). THE DFU STATE THE ULTRAFLEX ESOPHAGEAL STENT SYSTEM IS "INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS ONLY... AND INDICATED FOR OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULA." HOWEVER, ACCORDING TO THE COMPLAINANT, THE STENT WAS PLACED WITHIN THE DUODENUM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1