Ultraflex™ Esophageal NG M00513730Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 08714729716150), received between Jan 18, 2017 and Sep 17, 2026 — classified as 15 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (23 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 47 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Migration

  It was reported to Boston Scientific Corporation that an Ultraflex Esophageal NG Covered Distal Release Stent was implanted in the esophagus to treat a 6 cm malignant esophageal stenosis during an Endoscopic Retrograde Cholangiopancreatography Procedure (ERCP) performed on (b)(6) 2026. The patient's anatomy was tortuous and was dilated prior to stent placement. On (b)(6) 2026, post stent placement, it was noted under imaging examination that the stent had migrated. The stent was removed using biopsy forceps, and another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805009 ↗
• MalfunctionSep 10, 2026Activation, Positioning or Separation Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717104 ↗
• MalfunctionAug 11, 2026Positioning Failure; 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 stenosis during a stent placement procedure performed on (b)(6), 2026. During the procedure, it was noted that the stent was kinked, and the wire could not be pulled. The device was removed, and another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202713 ↗
• MalfunctionJun 30, 2026Premature Activation; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL COVERED STENT WAS TO BE IMPLANTED TO TREAT ESOPHAGEAL STENOSIS DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT WAS REPORTED TO HAVE DISLODGED OUTSIDE THE PATIENT. 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 25673470 ↗
• MalfunctionApr 20, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED TO TREAT ESOPHAGEAL STENOSIS IN THE ESOPHAGUS DURING AN ENDOSCOPIC PLACEMENT OF ESOPHAGEAL STENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER DEPLOYMENT, THE DEVICE FAILED TO EXPAND FULLY, WHICH AFFECTED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. 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 24932893 ↗
• MalfunctionMar 9, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ULTRAFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 6CM ESOPHAGEAL STENOSIS CAUSED BY A MALIGNANT NECROTIC TUMOR DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUROUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE SUCCESSFULLY DEPLOYED. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT, AT WHICH TIME THE STENT WAS OBSERVED TO BE PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24548010 ↗
• MalfunctionFeb 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 INTO THE ESOPHAGUS TO TREAT A SEVERE STENOSIS CAUSED BY A MALIGNANT TUMOR DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING PROCEDURE, THE DEVICE WAS UNABLE TO BE DEPLOYED NORMALLY. WHEN THE STENT WAS REMOVED FROM THE PATIENT IT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470644 ↗
• MalfunctionNov 28, 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 IN THE ESOPHAGUS TO TREAT ESOPHAGEAL STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. 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 AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT PARTIALLY DEPLOYED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23675582 ↗
• InjuryNov 3, 2025Use of Device Problem; Material Integrity Problem; Migration; Use of Device Problem; Material Integrity Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN APPROXIMATELY 5 CM EXOGENOUS BENIGN ESOPHAGEAL TUMOR DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE ULTRAFLEX ESOPHAGEAL STENT WAS DEPLOYED. HOWEVER, THE POSITION OF THE STENT COVER WAS CHANGED. THE STENT AND STENT COVER HAD MIGRATED, WHICH PROMPTED THE PHYSICIAN TO REMOVE THE STENT USING FORCEPS. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE STENT WAS USED TO TREAT A BENIGN TUMOR. 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. THE ULTRAFLEX ESOPHAGEAL NG COVERED STENT SYSTEM IS ALSO INDICATED FOR OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULA. THE DEVICE IS NOT INDICATED FOR PLACEMENT TO TREAT A BENIGN TUMOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457319 ↗
• MalfunctionSep 11, 2025Failure to Advance; Activation, Positioning or Separation Problem; Activation Failure; Failure to Advance; Activation, Positioning or Separation Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT 7CM ESOPHAGEAL STENOSIS DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TIGHT PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE FRONT END OF THE STENT HAD EXPANDED BEFORE DEPLOYMENT AND COULD NOT CROSS THE STENOSIS. THE STENT WAS THEN REMOVED TOGETHER WITH THE DELIVERY SYSTEM. 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 23033496 ↗
• MalfunctionJun 26, 2025Activation, 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 NG DISTAL COVERED STENT WAS TO BE IMPLANTED IN MID ESOPHAGUS STRICTURE TO TREAT AN ESOPHAGEAL CANCER DURING AN ESOPHAGUS STRICTURE PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER ULTRAFLEX. THERE WAS NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342525 ↗
• MalfunctionApr 16, 2025Unraveled Material; Activation, Positioning or Separation Problem; Unraveled Material; Activation, Positioning or Separation Problem

  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 5CM MALIGNANT STENTOSIS DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE POSTERIOR SEGMENT OF THE STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND THE PROCEDURE WAS COMPLETED USING ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WAS 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 21850912 ↗
• MalfunctionApr 9, 2025Break; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Break; 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 TO TREAT A 3CM MALIGNANT COMPLETE OBSTRUCTION OF THE LOWER ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND THE PROCEDURE WAS COMPLETED USING ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21807982 ↗
• MalfunctionNov 6, 2024Activation, 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 COVERED STENT WAS USED TO TREAT AN UNRESECTABLE ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEPLOYMENT OF THE STENT WAS INITIATED, BUT THE SUTURE BECAME STUCK, AND THE STENT COULD NOT BE FURTHER DEPLOYED. THE PHYSICIAN ATTEMPTED TO SLIGHTLY REPOSITION THE STENT AND RETRY THE DEPLOYMENT; HOWEVER, THE SUTURE REMAINED LODGED, PREVENTING THE STENT FROM BEING RELEASED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621474 ↗
• InjuryMay 8, 2024Activation, Positioning or Separation Problem; Material Deformation; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Deformation; Material Integrity 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 4CM MALIGNANT ESOPHAGEAL STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON APRIL 15, 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE STENT, THE DELIVERY SYSTEM ENCOUNTERED RESISTANCE AND BECAME STUCK AS 70% OF THE STENT WAS DEPLOYED. SUBSEQUENTLY, THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY COVERED BY THE DEPLOYMENT SUTURE WITH THE USE OF A SNARE. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE DEPLOYMENT SUTURE WAS TWISTED AND KNOTTED, AND THE STENT COVER WAS DAMAGED. 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 19269464 ↗
• InjuryJan 12, 2024Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL COVERED STENT WAS TO BE IMPLANTED TO TREAT ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS UNABLE TO UNFOLD. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507766 ↗
• InjuryJan 12, 2024Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL COVERED STENT WAS TO BE IMPLANTED TO TREAT ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT DID NOT UNFOLD AND HAD TO BE RETRACTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502009 ↗
• MalfunctionDec 7, 2023Activation, 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 NG DISTAL COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT ESOPHAGEAL STENOSIS DURING AN ESOPHAGEAL STRICTURE DILATATION 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 COULD NOT BE DEPLOYED INSIDE THE PATIENT. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18285879 ↗
• MalfunctionNov 14, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE MID ESOPHAGUS TO TREAT A 5CM STRICTURE DUE TO CANCER DURING A METAL 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 ATTEMPTED TO BE DEPLOYED; HOWEVER, IT GOT STUCK AND WAS UNABLE TO BE FULLY 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 18132886 ↗
• MalfunctionNov 8, 2023Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL COVERED STENT WAS TO BE IMPLANTED IN THE MID ESOPHAGUS TO TREAT A MALIGNANT 5 CM ESOPHAGEAL STRICTURE DURING AN ESOPHAGEAL SELF-EXPANDING METAL STENT (SEMS) IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THERE WAS RESISTANCE WHILE PULLING THE DEPLOYMENT SUTURE FOR SEVERAL TIMES AND IT COULD NOT BE RELEASED. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, AND IT WAS NOTED THE DEPLOYMENT SUTURE WAS TANGLED AND THE STENT WAS PARTIALLY ON THE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093526 ↗
• MalfunctionOct 3, 2023Activation, 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 NG DISTAL COVERED STENT WAS TO BE IMPLANTED IN THE LOWER PART OF THE ESOPHAGUS TO TREAT A MALIGNANT 6 CM 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 17863070 ↗
• InjuryAug 7, 2023Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 17, 2023 THAT AN ULTRAFLEX ESOPHAGEAL DISTAL COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGEAL GASTRIC JUNCTION TO TREAT A 3CM MALIGNANT STRICTURE DURING A STENT 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 DEPLOYED; HOWEVER, THE STENT WAS UNABLE TO EXPAND. SUBSEQUENTLY, WHEN THE DELIVERY SYSTEM WAS REMOVED, THE STENT BECAME STUCK AND WAS PULLED OUT OF ITS LOCATION. THE STENT WAS REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT OF A DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470722 ↗
• MalfunctionJul 26, 2023Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. ANOTHER ESOPHAGEAL STENT WAS USED 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT PARTIALLY DEPLOYED. PLEASE SEE BLOCK H10 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17399178 ↗
• InjuryMay 11, 2023Break; Difficult to Remove; Positioning Problem; Break; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 25, 2023, THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS FOR THE TREATMENT OF AN EXTENSIVE ESOPHAGEAL NEOPLASM DUE TO ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS DUE TO BIG TUMOR AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO REPOSITION THE STENT FOR BETTER COVERAGE OF THE NEOPLASM USING FORCEPS; HOWEVER, DURING THE REPOSITION ATTEMPT, THE STENT WIRE BROKE. THE STENT WAS UNABLE TO BE REMOVED AND THE PHYSICIAN IS COMFORTABLE LEAVING THE STENT IMPLANTED INSIDE THE PATIENT. THE PATIENT WAS KEPT UNDER OBSERVATION. ON (B)(6) 2023, ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS IMPLANTED STENT-IN-STENT INSIDE THE ORIGINAL 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916826 ↗
• InjuryMay 1, 2023Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 11, 2023 THAT AN ULTRAFLEX ESOPHAGEAL DISTAL COVERED STENT WAS IMPLANTED TO TREAT A 6CM STRICTURE IN THE DISTAL END OF ESOPHAGUS 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, THE STENT WAS FULLY DEPLOYED; HOWEVER, IT WAS NOTICED THAT THE STENT WAS UNABLE TO OPEN PROPERLY IN THE STRICTURE AND WAS INVERTED FROM BEHIND. THE STENT WAS REMOVED WITH FORCEPS AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **ADDITIONAL INFORMATION RECEIVED ON APRIL 28, 2023** THE STENT WAS IMPLANTED TO TREAT A 6CM MALIGNANT STRICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845071 ↗