Ultraflex™ Esophageal NG M00513740Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 08714729716167), received between Nov 30, 2016 and Jul 10, 2026 — classified as 15 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (26 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Activation, Positioning or Separation Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT ESOPHAGEAL CANCER IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT WAS FAILED TO FULLY EXPAND AFTER DEPLOYMENT. ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25786553 ↗
• MalfunctionApr 7, 2026Device Misassembled During Manufacturing /Shipping; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED TO THE ESOPHAGUS TO TREAT A SEVERE STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT WAS DISLOCATED AND COULD NOT CROSS THE STENOSIS LESION. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811403 ↗
• MalfunctionFeb 5, 2026Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED TO THE ESOPHAGUS TO TREAT AN 8CM SIZE OF LESION CAUSED BY MALIGNANCY DURING AN ENDOSCOPY GUIDED ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING PROCEDURE, WHILE PLACING THE STENT, THE STENT DEPLOYMENT SUTURE THREAD BROKE DOWN WHILE PULLING THE THREAD. WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS PARTIALLY DEPLOYED. DUE TO THIS EVENT, THE STENT WAS NOT IMPLANTED. INITIALLY, THE PROCEDURE WAS NOT COMPLETED. HOWEVER, ON THE DAY AFTER, THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274265 ↗
• MalfunctionJan 27, 2026Activation, 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 8CM STENOSIS CAUSED BY CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY COVERED WITH THE STENT-DEPLOYMENT SUTURE. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196056 ↗
• MalfunctionJan 13, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS INTENDED TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN OBSTRUCTION ASSOCIATED WITH INABILITY TO EAT DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT DID NOT EXPAND FULLY DURING DEPLOYMENT. THE DEVICE WAS RETRIEVED, AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053849 ↗
• MalfunctionJul 23, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG STENT WAS TO BE IMPLANTED TO TREAT A TIGHT 4 CM MID-ESOPHAGEAL STRICTURE DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE LOADING THE STENT ONTO THE GUIDEWIRE, THE DELIVERY CATHETER BECAME KINKED, PREVENTING SUCCESSFUL ADVANCEMENT OF THE STENT. DESPITE REMOVING AND REINSERTING THE DEVICE AND REPLACING THE GUIDEWIRE, THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT DUE TO PERSISTENT CATHETER KINKING. THE PROCEDURE WAS ABORTED AND RESCHEDULED FOR A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22581247 ↗
• MalfunctionMay 13, 2025Positioning Failure; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Positioning Failure; 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 TO TREAT A MALIGNANT STENOSIS IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULT WHICH REVEALED A PARTIALLY DEPLOYED ULTRAFLEX ESOPHAGEAL STENT. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009738 ↗
• InjuryApr 28, 2025Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration; Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST STENT PLACEMENT, IT WAS OBSERVED THAT THE COVER OF THE ULTRAFLEX ESOPHAGEAL STENT WAS DAMAGED AND HAD DISAPPEARED DUE TO EXPOSURE TO ACID. IT WAS ALSO NOTED THAT THE STENT COVER HAD MIGRATED. THE STENT WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Biliary Leak; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922266 ↗
• InjuryApr 28, 2025Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration; Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST STENT PLACEMENT, IT WAS OBSERVED THAT THE COVER OF THE ULTRAFLEX ESOPHAGEAL STENT WAS DAMAGED AND HAD DISAPPEARED DUE TO EXPOSURE TO ACID. IT WAS ALSO NOTED THAT THE STENT COVER HAD MIGRATED. THE STENT WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Biliary Leak; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922264 ↗
• InjuryApr 28, 2025Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration; Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST STENT PLACEMENT, IT WAS OBSERVED THAT THE COVER OF THE ULTRAFLEX ESOPHAGEAL STENT WAS DAMAGED AND HAD DISAPPEARED DUE TO EXPOSURE TO ACID. IT WAS ALSO NOTED THAT THE STENT COVER HAD MIGRATED. THE STENT WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Biliary Leak; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922242 ↗
• InjuryApr 28, 2025Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration; Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST STENT PLACEMENT, IT WAS OBSERVED THAT THE COVER OF THE ULTRAFLEX ESOPHAGEAL STENT WAS DAMAGED AND HAD DISAPPEARED DUE TO EXPOSURE TO ACID. IT WAS ALSO NOTED THAT THE STENT COVER HAD MIGRATED. THE STENT WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Biliary Leak; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922218 ↗
• InjuryApr 28, 2025Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration; Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST STENT PLACEMENT, IT WAS OBSERVED THAT THE COVER OF THE ULTRAFLEX ESOPHAGEAL STENT WAS DAMAGED AND HAD DISAPPEARED DUE TO EXPOSURE TO ACID. IT WAS ALSO NOTED THAT THE STENT COVER HAD MIGRATED. THE STENT WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Biliary Leak; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921513 ↗
• InjuryApr 28, 2025Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration; Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST STENT PLACEMENT, IT WAS OBSERVED THAT THE COVER OF THE ULTRAFLEX ESOPHAGEAL STENT WAS DAMAGED AND HAD DISAPPEARED DUE TO EXPOSURE TO ACID. IT WAS ALSO NOTED THAT THE STENT COVER HAD MIGRATED. THE STENT WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Biliary Leak; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921503 ↗
• InjuryApr 28, 2025Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration; Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST STENT PLACEMENT, IT WAS OBSERVED THAT THE COVER OF THE ULTRAFLEX ESOPHAGEAL STENT WAS DAMAGED AND HAD DISAPPEARED DUE TO EXPOSURE TO ACID. IT WAS ALSO NOTED THAT THE STENT COVER HAD MIGRATED. THE STENT WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Biliary Leak; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921409 ↗
• InjuryApr 28, 2025Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration; Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST STENT PLACEMENT, IT WAS OBSERVED THAT THE COVER OF THE ULTRAFLEX ESOPHAGEAL STENT WAS DAMAGED AND HAD DISAPPEARED DUE TO EXPOSURE TO ACID. IT WAS ALSO NOTED THAT THE STENT COVER HAD MIGRATED. THE STENT WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Biliary Leak; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921405 ↗
• InjuryApr 28, 2025Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration; Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST STENT PLACEMENT, IT WAS OBSERVED THAT THE COVER OF THE ULTRAFLEX ESOPHAGEAL STENT WAS DAMAGED AND HAD DISAPPEARED DUE TO EXPOSURE TO ACID. IT WAS ALSO NOTED THAT THE STENT COVER HAD MIGRATED. THE STENT WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Biliary Leak; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921392 ↗
• MalfunctionApr 21, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 7MM BY 90MM MALIGNANT ESOPHAGEAL OBSTRUCTION DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE SHAFT OF THE STENT SYSTEM ENTERED THE NARROW STENOSED SITE. THEY ATTEMPTED TO PULL THE SUTURE TO DEPLOY THE STENT; HOWEVER, THE STENT DID NOT DEPLOY. WHEN THEY CONTINUED PULLING THE SUTURE, THEY FOUND THAT THE DEPLOYMENT SUTURE WAS KNOTTED RESULTING IN STENT DEPLOYMENT FAILURE. THE STENT WAS NOT FULLY COVERED BY THE DEPLOYMENT SUTURE WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872476 ↗
• InjuryApr 17, 2025Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration; Break; Use of Device Problem; Material Deformation; Material Integrity Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS USED DURING A GASTROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. POST STENT PLACEMENT, IT WAS OBSERVED THAT THE COVER OF THE ULTRAFLEX ESOPHAGEAL STENT WAS DAMAGED AND HAD DISAPPEARED DUE TO EXPOSURE TO ACID. IT WAS ALSO NOTED THAT THE STENT COVER HAD MIGRATED. THE STENT WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON MAY 12, 2025. IT WAS REPORTED THAT THE STENT WAS PLACED POSSIBLY DUE TO BOERHAAVE SYNDROME IN MOST CASES, AND ALSO SOME POST OPERATIVE ESOPHAGEAL LEAKAGES.

  Patient problems: Biliary Leak; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861841 ↗
• MalfunctionJan 8, 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 USED TO TREAT A MALIGNANT ESOPHAGEAL STENOSIS DURING AN ESOPHAGEAL METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106370 ↗
• MalfunctionOct 24, 2024Activation, Positioning or Separation Problem; Human-Device Interface Problem; Material Twisted/Bent; Positioning Problem; Activation, Positioning or Separation Problem; Human-Device Interface Problem; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL COVERED STENT WAS USED DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN INTENDED TO PLACE A PROXIMAL RELEASE ULTRAFLEX ESOPHAGEAL STENT, BUT A DISTAL RELEASE ULTRAFLEX ESOPHAGEAL STENT WAS MISTAKENLY PLACED DUE TO THE ALMOST IDENTICAL PACKAGING OF BOTH STENTS. CONSEQUENTLY, THE STENT WAS REMOVED, AND AN ULTRAFLEX PROXIMAL RELEASE STENT WAS PLACED. THE PATIENT WAS THEN ADMITTED OVERNIGHT FOR OBSERVATION. REPORTEDLY, NO FURTHER INTERVENTION WAS REQUIRED, AND THE PATIENT WAS DISCHARGED WITHIN 24 HOURS. THERE WERE NO KNOWN PATIENT COMPLICATIONS DUE TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 28, 2024. THE STENT WAS USED TO TREAT A 5CM MALIGNANT STRICTURE PERFORMED ON (B)(6) 2024. THERE WERE NO ANATOMICAL PROBLEMS AND THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO FULLY DEPLOY AS THE DEPLOYMENT SUTURE WAS COILED UP AROUND THE STENT CAUSING THE SHAFT TO BEND. THE STENT WAS REMOVED WITHOUT THE USE OF A RETRIEVAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20526665 ↗
• InjuryJun 12, 2024Material Deformation; Device Stenosis; Material Deformation; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A NEOPLASM DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, POST-STENT PLACEMENT, THE PATIENT PRESENTED WITH SWALLOWING PROBLEMS. AN ENDOSCOPY WAS DONE, AND IT WAS CONFIRMED THAT THE STENT WAS OBSTRUCTED WITH SOFT SUBSTANCES (FOOD). UPON PUSHING THE OBSTRUCTION, IT WAS NOTED THAT THE DISTAL WIRES OF THE STENT WERE DEFORMED, CAUSING THE OBSTRUCTION. THE PATIENT WAS KEPT UNDER OBSERVATION, AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WILL LIKELY BE PLACED STENT-IN-STENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 19525110 ↗
• MalfunctionJan 18, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT 8 CM ESOPHAGEAL STRICTURE DURING A METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED, EVEN AFTER MULTIPLE ATTEMPTS AT PULLING THE DEPLOYMENT SUTURE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MODEL OF ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540239 ↗
• MalfunctionJan 16, 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 DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED FOR THE TREATMENT OF ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENTING 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 AND A DIFFERENT DEVICE 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 18519662 ↗
• MalfunctionOct 4, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT 8 CM ESOPHAGEAL STENOSIS DURING A STENT PLACEMENT 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 COULD NOT BE DEPLOYED. THE STENT WAS THEN REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17872668 ↗
• MalfunctionSep 21, 2023Failure to Advance; Activation, Positioning or Separation Problem; Material Deformation; Material Twisted/Bent; Failure to Advance; Activation, Positioning or Separation Problem; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT 5 CM ESOPHAGEAL OBSTRUCTION DURING AN ESOPHAGEAL STENTING 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 ADVANCING THE DELIVERY SYSTEM ACROSS THE LESION, AND THE SHAFT WAS KINKED. THE WHOLE DELIVERY SYSTEM WAS REMOVED AND RE-INSERTED, BUT THE SAME PROBLEM OCCURRED. THE STENT WAS ATTEMPTED TO BE DEPLOYED, BUT THE SHAFT ULTIMATELY BOWED, AND THE DISTAL PART OF THE STENT AUTOMATICALLY DEPLOYED PARTIALLY. THE STENT WAS REMOVED FROM THE PATIENT, AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789291 ↗