Ultraflex™ Esophageal NG M00513840Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729716099), received between Apr 19, 2017 and Sep 11, 2026 — classified as 8 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Unraveled Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739871 ↗
• MalfunctionMay 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED FROM THE LOWER ESOPHAGUS TO THE CARDIA TO TREAT ESOPHAGEAL CANCER DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DELIVERY SHAFT KINKED DURING INSERTION OF THE DEVICE INTO THE ESOPHAGEAL TRACT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS NOT COMPLETED. THERE WAS NO PATIENT COMPLICATION 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 21981405 ↗
• MalfunctionDec 10, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL COVERED STENT WAS USED TO TREAT A 5.6CM ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ADVANCED THROUGH THE THROAT ALONG WITH THE GUIDEWIRE; HOWEVER, THE STENT DEPLOYMENT SUTURE WAS RUBBED ON THE LESION SITE, CAUSING A BLEED. THE STENT WAS THEN WITHDRAWN, RE-SMEARED WITH COUPLANT, AND PLACED AGAIN AT THE LESION SITE, BUT THE SAME PROBLEM OCCURRED. UPON REMOVING THE DEVICE, IT WAS NOTED THAT THE TIP OF THE STENT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 20896729 ↗
• InjuryOct 2, 2024Use of Device Problem; Activation, Positioning or Separation Problem; Material Integrity Problem; Use of Device Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL COVERED STENT WAS USED IN THE ESOPHAGUS TO TREAT A 6CM BENIGN STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, UPON UNPACKING THE DEVICE, IT WAS NOTED THAT THE BULBOUS TIP OF THE STENT WAS BENT. SUBSEQUENTLY, AFTER ENTERING INSIDE THE PATIENT, THE WIRE WRAPPING THE STENT CUT THE TUMOR TISSUE. THE STENT WAS WITHDRAWN PARTIALLY COVERED BY THE DEPLOYMENT SUTURE ON THE DELIVERY SYSTEM AND WAS REMOVED USING FORCEPS. THERE WAS NO INTERVENTION OR TREATMENT DONE TO ADDRESS THE TISSUE DAMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THE PATIENT'S CONDITION FOLLOWING PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE ULTRAFLEX ESOPHAGEAL STENT WAS USED TO TREAT A 6CM BENIGN STENOSIS. HOWEVER, PER 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 SYST

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20353974 ↗
• MalfunctionDec 28, 2023Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL COVERED PROXIMAL RELEASE STENT WAS TO BE IMPLANTED IN THE MIDDLE AND LOWER ESOPHAGUS TO TREAT A MALIGNANT STENOSIS DURING ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PROXIMAL END HAS BEEN DEPLOYED. HOWEVER, THE DISTAL END OF THE STENT COULD NOT BE DEPLOYED. THE 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 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 18409733 ↗
• MalfunctionDec 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 PROXIMAL COVERED STENT WAS USED IN THE MIDDLE ESOPHAGUS TO TREAT MALIGNANT STENOSIS AND DYSPHAGIA 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 COULD NOT BE DEPLOYED INSIDE THE PATIENT. THE STENT WAS FULLY COVERED BY THE DEPLOYMENT SUTURE WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 WAS PARTIALLY DEPLOYED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393339 ↗
• MalfunctionNov 14, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 24, 2022 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PATIENT BECAME UNCOMFORTABLE, UPON CHECKING OF THE STENT, IT WAS NOTED THAT A SHARP WIRE PROTRUDED FROM THE DELIVERY SYSTEM. THE STENT WAS REMOVED AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Discomfort

  MAUDE report 15793203 ↗
• MalfunctionSep 26, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 6CM MALIGNANT STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE ULTRAFLEX ESOPHAGEAL STENT WAS UNABLE TO FULLY DEPLOY. THE ULTRAFLEX ESOPHAGEAL STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PATIENT'S ANATOMY WAS THEN DILATED WITH BALLOON AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486923 ↗
• MalfunctionFeb 22, 2022Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT "MISFIRED". THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579172 ↗
• MalfunctionDec 16, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DELIVERY SYSTEM COULD NOT CROSS THE LESION. THE STENT WAS REMOVED AND A WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE STENT WAS PARTIALLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020825 ↗
• MalfunctionDec 8, 2021Failure to Advance; Material Twisted/Bent; Positioning Problem; Activation Failure; Failure to Advance; Material Twisted/Bent; Positioning Problem; Activation Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-06336 AND 3005099803-2021-06337 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 15,2021 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A 12 CM MALIGNANT ESOPHAGEAL STENOSIS DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM OF A 15CM ULTRAFLEX ESOPHAGEAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2021-06336) THROUGH THE STRICTURE. THE DISTAL PART OF THE DELIVERY SYSTEM WAS BENT THE STENT WAS DEPLOYED IN AN INCORRECT LOCATION. IT WAS OBSERVED UNDER DIRECT VISUALIZATION WITH A PEDIATRIC GASTROSCOPE THAT THE STENT DID NOT FULLY EXPAND. THE STENT WAS REMOVED FROM THE PATIENT USING A RE-USABLE GRASPING FORCEPS. A 10 CM ULTRAFLEX ESOPHAGEAL STENT (SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE DEPLOYED, BUT SIMILAR PROBLEMS OCCURRED; THE DELIVERY SYSTEM HAD DIFFICULTY ADVANCING THROUGH THE STRICTURE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960101 ↗
• MalfunctionOct 25, 2021Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL COVERED STENT WAS TO BE IMPLANTED TO TREAT AN APPROXIMATELY 5CM MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, WHEN DEPLOYING THE STENT, THE BLACK DEPLOYMENT SUTURE BROKE. REPORTEDLY, THE STENT WAS PARTIALLY COVERED BY THE DEPLOYMENT SUTURE ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH 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 12693701 ↗
• InjuryApr 14, 2021Positioning Problem; Activation Failure; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2021 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL COVERED STENT WAS TO BE IMPLANTED TO TREAT MALIGNANT TUMORS IN THE MIDDLE AND LOWER ESOPHAGUS DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, AFTER DEPLOYMENT, IT WAS OBSERVED THAT THE STENT MOVED OUT OF ITS POSITION. THE STENT WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE LOWER END OF THE STENT DID NOT COMPLETELY EXPAND. 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 AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11664742 ↗
• MalfunctionJan 8, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 18, 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A 5CM ESOPHAGEAL STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED INSIDE THE PATIENT. REPORTEDLY, THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. 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.

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

  MAUDE report 11141971 ↗
• MalfunctionJan 7, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 12, 2019 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT A STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT WAS NOT ABLE TO BE FULLY RELEASED. THE DEVICE WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL 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 Consequences Or Impact To Patient

  MAUDE report 9559506 ↗
• InjurySep 18, 2019Failure to Advance; Material Deformation; Positioning Problem; Failure to Advance; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE MID TO DISTAL ESOPHAGUS DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT, NAVIGATION OF THE SCOPE WAS NOT POSSIBLE AND STRICTURE WAS DILATED USING SAVERY DILATOR TO UP TO 12 CM PRIOR TO STENT PLACEMENT PROCEDURE. THE ENDOSCOPE WAS THEN ABLE TO BE PASSED AND THE STRICTURE WAS MEASURED TO BE FROM 27 CM POINT ON THE ENDOSCOPE TO THE 33 CM POINT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ENDOSCOPE WAS PLACED AT THE SIDE TO VIEW THE STENT, THE CATHETER WAS POSITIONED AT 25 CM AND THE STENT WAS RELEASED. HOWEVER, FOLLOWING DEPLOYMENT IT WAS NOTED THAT THE CATHETER HAD KINKED AT THE DISTAL END OF THE STRICTURE AND DID NOT CROSS THE LESION. REPORTEDLY, THE STENT WAS DEPLOYED PROXIMAL TO THE INTENDED LOCATION. THE STENT WAS REMOVED WITH RAT TOOTH FORCEPS AND ANOTHER ULTRAFLEX ESOPHAGEAL 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 PROCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084160 ↗
• InjuryJul 16, 2019Break; Use of Device Problem; Activation, Positioning or Separation Problem; Break; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE USED IN THE JEJUNUM DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT HAD A "NOT TOTAL GASTRECTOMY" PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, A WEEK BEFORE THIS ESOPHAGEAL STENTING PROCEDURE, A PRIOR ULTRAFLEX ESOPHAGEAL STENT HAD BEEN IMPLANTED. HOWEVER, ANOTHER STENOSIS WAS NOTED BEHIND (AT THE DISTAL END OF) THE PRIOR IMPLANTED STENT. THERE WERE NO ISSUES WITH THE PRIOR IMPLANTED STENT. ON (B)(6) 2019, DURING THE STENT PLACEMENT PROCEDURE, THE STENT WAS DEPLOYED PARTIALLY AND WAS ABLE TO COVER 10 CM OF THE AREA OF THE STENOSIS. BY THE TIME THE DEPLOYMENT SUTURE WAS ABOUT TO FINISH, THE STENT DEPLOYMENT SUTURE BECAME STUCK. THE PHYSICIAN FORCIBLY PULLED THE DEPLOYMENT SUTURE, AND IT SNAPPED/SEPARATED, AND IT WAS UNABLE TO CONTINUE DEPLOYING THE STENT. THE PHYSICIAN TRIED TO EXPOSE THE SUTURE BY CUTTING THE PROXIMAL SIDE OF THE DELIVERY SYSTEM, BUT IT WAS UNABLE TO FIND THE SUTURE. REPORTEDLY, THE PHYSICIAN ATTEMPTED TO SEPARATE THE DELIVERY SYSTEM FROM THE STENT LUMEN BY BURNING THE STENT TIP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795202 ↗
• InjuryJul 11, 2019Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 19, 2019 THAT AN ULTRAFLEX ESOPHAGEAL NG COVERED PROXIMAL RELEASE STENT WAS TO BE USED TO TREAT A 7CM MALIGNANT STENOSIS IN THE CARDIA OF THE STOMACH DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING STENT DEPLOYMENT, THE SHAFT KINKED AND THE STENT DEPLOYED PREMATURELY NOT IN THE PROPER POSITION. THE STENT WAS REMOVED WITH FORCEPS AND 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780712 ↗
• MalfunctionJun 26, 2019Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STRING SNAPPED BEFORE RELEASING THE STENT. DESPITE NUMEROUS ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8736948 ↗
• InjuryMay 14, 2019Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL COVERED STENT WAS TO BE USED TO TREAT AN ESOPHAGEAL STENOSIS DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE DELIVERY SYSTEM WAS PULLED OUT FROM THE STRICTURE AND THE STENT DEPLOYED UPON REMOVAL. THE STENT WAS REMOVED WITH A SNARE AND DIFFERENT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609909 ↗
• MalfunctionDec 20, 2018Activation, 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 PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT A STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING STENT DEPLOYMENT, THE DELIVERY SYSTEM WAS KINKED. THE DEVICE WAS REMOVED FROM THE PATIENT 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 FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED A PARTIALLY DEPLOYED ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185291 ↗
• MalfunctionJun 6, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT A 6CM MALIGNANT STRICTURE DURING ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT DEPLOYMENT SUTURE BROKE, AND THE STENT FAILED TO DEPLOY. 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 AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7573826 ↗
• InjuryFeb 2, 2018Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018, THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS 12 CM FROM THE ROW OF TEETH DURING A GASTROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE ANATOMY OF THE PATIENT WAS VERY TIGHT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT. HOWEVER, THE STENT FAILED TO EXPAND AT THE FLARE/TULIP. THE PHYSICIAN TRIED TO DILATE THE STENT USING A DILATION BALLOON, HOWEVER, THE STENT STILL FAILED TO EXPAND. THE PHYSICIAN REMOVED THE STENT USING FORCEPS AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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 7237503 ↗
• InjuryApr 19, 2017Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ULTRAFLEX¿ ESOPHAGEAL PROXIMAL RELEASE COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A 3 CM NEOPLASTIC STENOSIS IN THE UPPER ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT WAS SEDATED AND VITAL PARAMETERS WERE CONTINUOUSLY MONITORED. ACCORDING TO THE COMPLAINANT, 19 TO 23 CM FROM THE ORAL FISSURE, A 3 CM NEOPLASTIC STENOSIS WAS NOTED IN THE UPPER ESOPHAGUS. THE PHYSICIAN USED A PEDIATRIC GASTRO SCOPE TO PASS THROUGH THE STRICTURE. AT THE CARDIA LEVEL, 39 TO 43 CM FROM THE ORAL FISSURE, ANOTHER 5 CM NEOPLASTIC STRICTURE WAS NOTED. A GUIDEWIRE WAS INSERTED UP TO THE DUODENUM AND IT WAS NOTED THAT THE STENT HAD DIFFICULTY CROSSING THE STENOSIS. THE STRICTURE WAS DILATED FOR ABOUT 10 MM AND THE STENT DEPLOYED BELOW THE UPPER ESOPHAGEAL SPHINCTER, 20 TO 21 CM FROM THE ORAL FISSURE. AFTER DEPLOYMENT, IT WAS NOTED THAT THE PROXIMAL END OF THE STENT DID NOT FULLY EXPAND. A 15MM DILATATION WAS PERFORMED WITH GOOD BALLOON INFLATION. ON (B)(6) 2017, A SCHEDULED CHECK -UP WAS DONE FOR STENT PLACEMENT TO TREAT THE CARDIA STENOSIS. IT WAS NOTED THAT TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6503212 ↗