Ultraflex™ Esophageal NG M00513750Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 08714729649113), received between Jan 5, 2017 and Jun 24, 2026 — classified as 1 death, 11 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (19 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL COVERED STENT WAS TO BE IMPLANTED TO TREAT AN APPROXIMATELY 10 CM ESOPHAGEAL STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ADVANCED OVER A GUIDEWIRE; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DELIVERY SYSTEM. DESPITE PRIOR DILATION OF THE STRICTURE, THE CATHETER BECAME BENT, PREVENTING SUCCESSFUL STENT DEPLOYMENT. THE STENT WAS REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25607922 ↗
• MalfunctionJan 26, 2026Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE IN THE MID ESOPHAGEAL DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, APPROXIMATELY 95 PERCENT OF THE STENT WAS SUCCESSFULLY DEPLOYED AND EXPANDED WELL. HOWEVER, DURING THE FINAL STAGE OF DEPLOYMENT, WHEN THE PHYSICIAN ATTEMPTED TO EXPAND THE REMAINING 5 PERCENT OF THE STENT, IT FAILED TO OPEN AS EXPECTED. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE SYSTEM, AFTER WHICH THE STENT EXPANDED NORMALLY OUTSIDE THE PATIENT. ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON JANUARY 20, 2026. *** IT WAS REPORTED THAT THE TREAD OF THE STENT BREAKS DOWN UNABLE TO RELEASE THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184916 ↗
• MalfunctionDec 4, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL COVERED STENT WAS ATTEMPTED TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN 8CM MALIGNANT ESOPHAGEAL STENOSIS DURING AN ESOPHAGEAL STENOSIS DILATION PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS (TIGHT) AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT COULD NOT BE RELEASED. IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717667 ↗
• MalfunctionMar 31, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 9CM STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON MARCH 6, 2025. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE THREAD GOT STUCK, AND THE STENT WAS UNABLE TO BE FULLY DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731225 ↗
• MalfunctionJul 24, 2024Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL STRICTURE DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS NOT OPENING AND PROCEDURE GOT CANCELLED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINT AND SHOWED THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JULY 28, 2024: IT WAS REPORTED THAT THE ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE LOWER ESOPHAGEAL SPHINCTER. THE PROCEDURE WAS COMPLETED WITH A WALLFLEX ESOPHAGEAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817175 ↗
• MalfunctionSep 11, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL COVERED STENT WAS USED TO TREAT A 9CM MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN UPPER GASTROINTESTINAL ENDOSCOPY (UGI) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS VERY TIGHT AND WAS DILATED UP TO 11MM PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DEPLOYMENT SUTURE BECAME STUCK AND THE STENT WAS UNABLE TO DEPLOY. THE STENT WAS PARTIALLY COVERED BY THE DEPLOYMENT SUTURE ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17724935 ↗
• MalfunctionJul 10, 2023Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 23, 2023, THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE MID ESOPHAGUS TO TREAT A 11CM MALIGNANT LESION DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO FULLY EXPAND AND GOT CAUGHT ON THE DELIVERY SYSTEM DURING REMOVAL. THE STENT WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17294787 ↗
• MalfunctionJun 5, 2023Positioning Failure; Failure to Advance; Detachment of Device or Device Component; Positioning Failure; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 18, 2023 THAT AN ULTRAFLEX ESOPHAGEAL DISTAL COVERED STENT WAS USED IN THE ESOPHAGUS TO TREAT AN 8CM MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN CROSSING THE STRICTURE. SUBSEQUENTLY, THE SHAFT BROKE AND THE STENT WAS UNABLE TO DEPLOY. THE STENT WAS FULLY COVERED BY THE DEPLOYMENT SUTURE WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CANCELLED DUE TO DEVICE AVAILABILITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17065239 ↗
• MalfunctionMay 19, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 05, 2023, THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS FOR THE TREATMENT OF ESOPHAGEAL CANCER DURING AN ESOPHAGEAL SEMS PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16965330 ↗
• InjuryApr 17, 2023Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS IMPLANTED TO TREAT ESOPHAGEAL NEOPLASM DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, FIVE DAYS POST STENT PLACEMENT, THE PATIENT COULD NOT EAT. AN ENDOSCOPY WAS PERFORMED, AND IT WAS NOTED THAT THE ULTRAFLEX ESOPHAGEAL STENT DID NOT EXPAND. THE STENT WAS REMOVED FROM THE PATIENT AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS IMPLANTED IN A SATISFACTORY MANNER AND THE PROCEDURE WAS COMPLETED. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THE PATIENT IS NOW OKAY AND CAN FEED PROPERLY. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE STENT WAS FULLY DEPLOYED INSIDE THE PATIENT; HOWEVER, THE STENT WAS NOT FULLY EXPANDED. ADDITIONAL INFORMATION RECEIVED ON APRIL 17, 2023. ON (B)(6) 2023, THE ULTRAFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT USING FORCEPS.

  Patient problems: Dysphagia/ Odynophagia; Obstruction/Occlusion

  MAUDE report 16750541 ↗
• MalfunctionMar 6, 2023Failure to Advance; Activation, Positioning or Separation Problem; Failure to Advance; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 15, 2023, THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN INVASIVE 9 CM STENOSIS DUE TO ESOPHAGEAL CANCER DURING AN ENDOSCOPIC ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN WAS HAVING DIFFICULTY REACHING THE POSTERIOR SEGMENT OF THE STENOSIS, SO THE LESION WAS DILATED WITH AN ENDOSCOPE. THE ULTRAFLEX ESOPHAGEAL STENT WAS THEN ATTEMPTED TO BE DEPLOYED, BUT IT COULD NOT BE DEPLOYED NORMALLY DESPITE REPEATEDLY ROTATING THE DEVICE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16489410 ↗
• MalfunctionFeb 8, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 13, 2023, THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN 11CM MALIGNANT TUMOR DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6), 2023. BOTH ENDS OF THE PATIENT'S LESION WERE OCCLUDED. THE PATIENT ANATOMY WAS DILATED WITH A BALLOON CATHETER PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE ULTRAFLEX ESOPHAGEAL STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY COVERED WITH STENT DEPLOYMENT SUTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE STENT WAS PARTIALLY DEPLOYED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16322341 ↗
• MalfunctionNov 21, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 04, 2022, THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT ESOPHAGEAL CANCER DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE BLACK STENT DEPLOYMENT SUTURE GOT STUCK AND THE ULTRAFLEX ESOPHAGEAL STENT WAS UNABLE TO BE FULLY DEPLOYED. THE ULTRAFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837942 ↗
• MalfunctionNov 18, 2022Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT ESOPHAGEAL CANCER DURING AN ESOPHAGEAL SELF-EXPANDING METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE ULTRAFLEX ESOPHAGEAL STENT DID NOT FULLY DEPLOY. THE ULTRAFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828264 ↗
• MalfunctionOct 5, 2022Failure to Advance; Material Deformation; Activation Failure; Failure to Advance; Material Deformation; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL CARCINOMA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE ULTRAFLEX DELIVERY CATHETER GOT KINKED AND WAS UNABLE TO ADVANCE THROUGH THE STRICTURE. THE DEVICE WAS REMOVED AND A DIFFERENT STENT WAS USED 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE ULTRAFLEX ESOPHAGEAL STENT DID NOT FULLY EXPAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545244 ↗
• InjuryAug 10, 2022Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2022, POST STENT PLACEMENT, IT WAS NOTED THAT THE ULTRAFLEX ESOPHAGEAL STENT HAD A PARTIAL, DISTAL MIGRATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203117 ↗
• MalfunctionMay 11, 2021Failure to Advance; Material Deformation; Appropriate Device Problem Term/Code Not Available; Failure to Advance; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 21, 2021 THAT AN ULTRAFLEX ESOPHAGEAL NG COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED TO TREAT ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE CATHETER KINKED AND THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS NOT COMPLETED AND WAS RESCHEDULED DUE TO DEVICE AVAILABILITY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807238 ↗
• MalfunctionJan 22, 2021Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available; Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 04, 2021 THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE LOWER ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEPLOYMENT SUTURE WOULD NOT RELEASE. THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. REPORTEDLY, THE PROCEDURE WAS NOT COMPLETED BECAUSE THE SAME DEVICE WAS UNAVAILABLE AT THE TIME OF 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11214904 ↗
• MalfunctionDec 1, 2020Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATIMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. 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. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT LOOPS WERE BENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10927285 ↗
• MalfunctionNov 11, 2020Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL CANCER DURING AN ESOPHAGEAL SELF-EXPANDING METAL STENT (SEMS) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED INSIDE THE PATIENT. THE BLACK STENT DEPLOYMENT SUTURE WAS NOT RELEASING AND VERY TIGHT. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE STENT LOOPS WERE BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10822295 ↗
• MalfunctionNov 6, 2020Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN UPPER GASTROINTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY. THE PHYSICIAN APPLIED FORCE AND THE STENT EVENTUALLY DEPLOYED; HOWEVER, DURING CATHETER REMOVAL, THE STENT CAME OUT OF THE PATIENT'S MOUTH ALONG WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10803542 ↗
• MalfunctionSep 30, 2020Use of Device Problem; Failure to Advance; Activation, Positioning or Separation Problem; Material Deformation; Use of Device Problem; Failure to Advance; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT TRACHEOESOPHAGEAL FISTULA DURING AN UPPER GASTROINTESTINAL WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE UNPACKING THE STENT, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED EVEN WITHOUT MANIPULATION. THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICE INTO THE PATIENT BUT WAS UNABLE TO CROSS THE STRICTURE. THE STENT WAS REMOVED AND IT WAS NOTED THAT TWO UNCOVERED CELLS WERE OPENED VERTICAL TO THE CATHETER MAKING IT DIFFICULT TO ADVANCE THROUGH THE STRICTURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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. NOTE: ACCORDING TO THE COMPLAINANT, THE ULTRAFLEX ESOPHAGEAL STENT WAS FOUND PARTIALLY DEPLOYED DURING UNPACKING AND THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT THROUGH THE STRICTURE. PER THE ULTRAFLEX ESOPHAGEAL NG COVERED STENT SYSTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10609918 ↗
• MalfunctionSep 23, 2020Activation, Positioning or Separation Problem; Material Deformation; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT MIDDLE ESOPHAGEAL STRICTURE DURING AN UPPER GASTROINTESTINAL (UGI) WITH ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT DEPLOYMENT SUTURE COULD NOT BE PULLED WHICH CAUSED THE CATHETER TO BEND AND THE STENT FAILED TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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. A PHOTO OF THE DEVICE PROVIDED BY THE COMPLAINANT SHOWS THAT THE STENT WAS PARTIALLY DEPLOYED AND THE SHAFT WAS BENT. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT LOOPS WERE BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10573268 ↗
• InjurySep 9, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 18, 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE AT THE MID TO DISTAL ESOPHAGUS DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED WITH CRE (CONTROLLED RADIAL EXPANSION) BALLOON PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A 15CM ULTRAFLEX ESOPHAGEAL STENT WAS SUCCESSFULLY PLACED STENT IN STENT WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. REPORTEDLY, 4 DAYS POST STENT PLACEMENT, THE PATIENT PRESENTED WITH VOMITING. ENDOSCOPY WAS PERFORMED AND A PEDIATRIC SCOPE WAS USED TO ACCESS THE STRICTURE. IT WAS FOUND OUT THAT THE 15 CM STENT DID NOT FULLY EXPAND AND SEVERE KINKING WAS OBSERVED. THE STENT HAD WIRES PROTRUDING TOWARDS THE MIDDLE OF THE STENT. REPORTEDLY, THE STENT REMAINS IMPLANTED AND THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACED. THE PHYSICIAN PLACED A RYLES TUBE IN THE STOMACH WHILE THE PATIENT WAS UNDER OBSERVATION BEFORE THE RE-STENTING PROCEDURE. AN 18MM X 15 CM WALLFLEX FULLY COVERED STENT WAS PLACED OVER THE DAMAGED ULTRAFLEX STENT TO COM

  Patient problems: No Code Available; Vomiting

  MAUDE report 10507007 ↗
• MalfunctionAug 17, 2020Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A STENOSIS IN THE ESOPHAGUS DURING ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE PHYSICIAN NOTICED THAT THE TIP OF THE STENT WAS PARTIALLY DEPLOYED. REPORTEDLY, THE STENT WAS NEVER INTRODUCED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE STENT LOOPS WERE BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10413393 ↗