BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ ESOPHAGEAL NG

    MDR report key: 2250770 · Received September 16, 2011

    Report

    Report Number
    3005099803-2011-03176
    Event Type
    Malfunction
    Date Received
    September 16, 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 RECEIVED FOR EVALUATION. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT COVER WAS MISSING. NO OTHER ISSUES WERE NOTED WITH THE STENT. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, 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." HOWEVER, THE COMPLAINT NOTES THAT THE STENT WAS USED TO TREAT A BENIGN LESION. ADDITIONALLY, 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, ACCORDING TO THE COMPLAINANT, THE STENT WAS REMOVED FROM THE PATIENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS USER ERROR.

    Additional Manufacturer Narrative · 1

    PATIENT IS OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. 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 PLACED ON AN UNKNOWN DATE TO TREAT A BENIGN LESION WITHIN THE PATIENT'S ESOPHAGUS. ACCORDING TO THE COMPLAINANT, DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR A PLANNED STENT REMOVAL ON AN UNKNOWN DATE, THE PHYSICIAN WENT TO REMOVE THE STENT AND TISSUE INGROWTH WAS NOTICED THROUGH THE STENT COVERING IN MULTIPLE PLACES. THE STENT COVERING APPEARED TO BE "DISINTEGRATING." THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "FINE" POST PROCEDURE. IT IS IMPORTANT TO NOTE THAT THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU). THE DFU STATES THAT THE ULTRAFLEX ESOPHAGEAL NG 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 USED TO TREAT A BENIGN LESION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL COVERED STENT WAS PLACED ON AN UNKNOWN DATE TO TREAT A BENIGN LESION WITHIN THE PATIENT'S ESOPHAGUS. ACCORDING TO THE COMPLAINANT, DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR A PLANNED STENT REMOVAL ON AN UNKNOWN DATE, THE PHYSICIAN WENT TO REMOVE THE STENT AND TISSUE INGROWTH WAS NOTICED THROUGH THE STENT COVERING IN MULTIPLE PLACES. THE STENT COVERING APPEARED TO BE "DISINTEGRATING." THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "FINE" POST PROCEDURE. IT IS IMPORTANT TO NOTE THAT THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU). THE DFU STATES THAT THE ULTRAFLEX ESOPHAGEAL NG 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 USED TO TREAT A BENIGN LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX¿ ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513730

    Patients

    Seq Age Sex Outcome Treatment
    1