Ultraflex™ Esophageal NG M00514250Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729716112), received between May 3, 2017 and Nov 17, 2025 — classified as 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT AN UNSPECIFIED CONDITION DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, TWO WEEKS AFTER THE IMPLANT PROCEDURE, THE STENT RUPTURED INSIDE THE PATIENT ESOPHAGUS. THE STENT WAS SUBSEQUENTLY EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576970 ↗
• MalfunctionJun 13, 2025Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A BENIGN ESOPHAGEAL STRICTURE DURING AN ULTRAFLEX ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, THE PATIENT CONDITION WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE ULTRAFLEX ESOPHAGEAL STENT WAS USED TO TREAT A BENIGN ESOPHAGEAL STRICTURE. HOWEVER, PER THE ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM STENT SYSTEM DIRECTIONS FOR USE, THE STENT 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 THE TREATMENT OF BENIGN ESOPHAGEAL STRICTURE. ADDITIONAL INFORMATION RECEIVED ON 03JUN2025: THE STENT WAS NOT INSERTED THROUGH THE WORKING CHANNEL, THE TECHNIQUE USED WAS THE OVER-THE-WIRE SYSTEM. IT DID NOT OPEN DURING THE DEPLOYM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207938 ↗
• InjuryMay 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENTS WAS IMPLANTED TO TREAT AN ESOPHAGEAL STRICTURE DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE STENT WAS DEPLOYED, A SMALL METAL RING-SHAPED OBJECT WAS NOTED INSIDE THE STENT. THE METAL RING WAS REMOVED FROM THE PATIENT. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT, SHOWING THAT THE STENT WAS DEPLOYED INSIDE THE PATIENT WITH A SMALL METAL RING-SHAPED OBJECT INSIDE THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030256 ↗
• InjuryJan 12, 2024Break; Human-Device Interface Problem; Device Stenosis; Break; Human-Device Interface Problem; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL RELEASE COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS FOR THE TREATMENT OF A 2CM STENOSIS DUE TO ESOPHAGEAL CANCER DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2023, IT WAS OBSERVED THAT THE STENT'S DISTAL END HAD OVERGROWTH. THE STENT WAS MOVED SLIGHTLY DISTALLY USING RAT TOOTH GRASPING FORCEPS. DURING THE PROCEDURE, IT WAS ALSO NOTED THAT THE STENT WAS OBSTRUCTED BY A SMALL AMOUNT OF FOOD. THE PHYSICIAN PUSHED PAST SOME IMPACTED FOOD AND FOUND THAT THE STENT HAD BROKEN INTO TWO PIECES. THE PATIENT WAS REFERRED TO A DIFFERENT HOSPITAL FOR STENT REMOVAL AND PLACEMENT OF A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18501852 ↗
• InjuryDec 28, 2022Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL COVERED STENT WAS TO BE IMPLANTED TO TREAT AN 8CM MALIGNANT STRICTURE IN THE MIDDLE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, IT WAS NOTED THAT THE STENT WAS UNABLE TO EXPAND. CONSEQUENTLY, A CRE BALLOON DILATATION WAS USED TO FACILITATE STENT EXPANSION BUT THE RESULT WAS NOT GOOD. AN UPPER GI ENDOSCOPY WAS PERFORMED AFTER 48HRS AND IT WAS NOTED THAT THE STENT WAS ABLE TO EXPAND PARTIALLY WITH KINK IN THE MIDDLE. SUBSEQUENTLY, THE STENT WAS REMOVED WITH A RAT-TOOTH FOREIGN BODY FORCEPS AND A DIFFERENT DEVICE 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: PHOTOS OF THE EXPLANTED ULTRAFLEX ESOPHAGEAL STENT WERE PROVIDED AND IT WAS OBSERVED THAT THE STENT WAS UNABLE TO EXPAND COMPLETELY AND WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061990 ↗
• MalfunctionAug 8, 2022Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A 7CM ESOPHAGEAL STRICTURE DURING AN UPPER GASTROINTESTINAL (UGI) ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, WHILE TRYING TO DEPLOY THE ULTRAFLEX ESOPHAGEAL STENT, RESISTANCE WAS MET AND THE SHAFT STARTED TO BEND. WHEN THE ULTRAFLEX ESOPHAGEAL STENT WAS PARTIALLY RELEASED, THE STENT DEPLOYMENT SUTURE BECAME STUCK AND THE ULTRAFLEX ESOPHAGEAL STENT COULD NOT BE DEPLOYED FURTHER. THE ULTRAFLEX ESOPHAGEAL 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 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 15188495 ↗
• MalfunctionJun 7, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 16, 2022 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE DISTAL ESOPHAGUS TO TREAT A 7CM ESOPHAGEAL CANCER DURING AN ESOPHAGEAL SELF-EXPANDING METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT WAS INTRODUCED OVER THE WIRE AND DEPLOYMENT WAS STARTED. AFTER PULLING THE STENT DEPLOYMENT SUTURE OVER 2 TO 3 CM, RESISTANCE WAS FELT AND THE STENT WAS UNABLE TO FULLY DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THE STENT WAS ABLE TO BE DEPLOYED OUTSIDE THE PATIENT AFTER SOME RESISTANCE. 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 14621671 ↗
• InjuryAug 18, 2021Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL COVERED STENT WAS IMPLANTED TO TREAT A 6CM MALIGNANT ESOPHAGEAL STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2021, POST STENT PLACEMENT, THE PATIENT PRESENTED WITH DISCOMFORT IN THE STOMACH. ENDOSCOPY WAS PERFORMED AND IT WAS NOTED THAT THE STENT HAD MIGRATED DISTALLY. THERE WAS DIFFICULTY IN REMOVING THE STENT BUT IT WAS ABLE TO BE REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Discomfort

  MAUDE report 12338002 ↗
• MalfunctionFeb 6, 2020Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 16, 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT AN ESOPHAGEAL STRICTURE DURING AN OESOPHAGOGASTRODUODENOSCOPY (OGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THEY WERE TO DEPLOY THE STENT, IT WAS NOTED THAT THE STENT WAS KINKED. 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 9677943 ↗
• InjuryApr 12, 2019Use of Device Problem; Component Missing; Use of Device Problem; Component Missing

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS IMPLANTED IN THE MID ESOPHAGUS DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE TO COVER AN ESOPHAGEAL PERFORATION. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019 ABOUT A WEEK AFTER STENT IMPLANTATION, A RE-GASTROSCOPY WAS PERFORMED AND THE COVER OF THE STENT WAS NOTED TO BE MISSING IN SOME PARTS. THE STENT WAS REMOVED WITH GRASPING FORCEPS AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS PLACED TO SEAL THE PERFORATION. 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: ACCORDING TO THE COMPLAINANT, THE ULTRAFLEX ESOPHAGEAL NG STENT WAS IMPLANTED TO COVER A PERFORATION; HOWEVER, 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.

  Patient problems: No Code Available

  MAUDE report 8510051 ↗
• InjuryDec 27, 2018Unraveled Material; Positioning Problem; Unraveled Material; Positioning Problem

  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 MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE ON (B)(6) 2018. 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 WAS FULLY DEPLOYED INSIDE THE PATIENT. REPORTEDLY, THE PHYSICIAN MOVED THE STENT UP WITH FORCEPS, AND THE PROXIMAL END OF THE STENT WAS DISCONNECTED/ UNRAVELED. THE STENT WAS REMOVED WITH FORCEPS 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 Consequences Or Impact To Patient

  MAUDE report 8200120 ↗
• MalfunctionNov 12, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT HAS BEEN IMPLANTED TO TREAT A STRICTURE DUE TO ESOPHAGEAL CARCINOMA IN THE LOWER ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TIGHT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED. IMAGING WAS PERFORMED AND NOTICED THE STENT MOVED OUT OF POSITION. REPORTEDLY, THE STENT REMAINED IMPLANTED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8061572 ↗
• MalfunctionOct 10, 2018Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 12, 2018 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL RELEASE COVERED STENT WAS TO BE USED DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON SEPTEMBER 11, 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "THE STENT WAS HALF OPENED AND THREAD WAS RELEASED". THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7954105 ↗
• InjuryJul 27, 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 IMPLANTED TO TREAT A STRICTURE DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, DURING PROCEDURE, THE STENT WAS IMPLANTED INSIDE THE PATIENT. REPORTEDLY, ON (B)(6) 2018, THE STENT WAS NOT FULLY EXPANDED. IT WAS NOT REPORTED WHETHER THE STENT REMAINS IMPLANTED OR IF IT WAS REMOVED, HOWEVER IT WAS REPORTED THAT 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. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION AND/OR SPECIFIC INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THESE EVENTS TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7727578 ↗
• InjuryApr 2, 2018Material Integrity Problem; Material Integrity Problem

  THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2018-01061 AND 3005099803-2018-01062 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT TWO ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENTS HAD BEEN IMPLANTED TO TREAT A MALIGNANT STRICTURE CONCURRENT WITH AN ESOPHAGEAL FISTULA DURING TWO STENT PLACEMENT PROCEDURES. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE FIRST ULTRAFLEX STENT (THE SUBJECT OF REPORT# 3005099803-2018-01061) WAS SUCCESSFULLY DEPLOYED INSIDE THE PATIENT. HOWEVER, ON (B)(6) 2018, THE PATIENT PRESENTED SYMPTOMS ASSOCIATED WITH ESOPHAGEAL FISTULA WHICH PROMPTED THE PHYSICIAN TO CHECK THE STENT. IT WAS NOTED THAT THE STENT COVER WAS DAMAGED AND THE FISTULA REMAINED OPEN. THE PHYSICIAN REMOVED THE FIRST STENT WITH FORCEPS AND A SECOND ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT (THE SUBJECT OF THIS REPORT) WAS IMPLANTED ON THE SAME TARGET SITE. REPORTEDLY, ON (B)(6) 2018, THE PATIENT WAS NOT WELL DUE TO THE SAME REASON; THE STENT COVER WAS DAMAGED AND THE FISTULA WAS STILL OPEN. ON THE SAME DAY, THE SECOND STENT WAS

  Patient problems: No Code Available

  MAUDE report 7390558 ↗
• MalfunctionJan 3, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT A GASTROESOPHAGEAL JUNCTION STRICTURE DUE TO ESOPHAGEAL CANCER DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED DEPLOYING THE STENT, HOWEVER, THE SHAFT WAS KINKED AND THE STENT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED 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 7160717 ↗
• MalfunctionMay 3, 2017Knotted; Knotted

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL RELEASE STENT WAS TO BE USED IN THE ESOPHAGUS TO TREAT A MALIGNANT TUMOR DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE PATIENT'S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT BE RELEASED. THE DEVICE WAS REMOVED FROM THE PATIENT AND 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE ULTRAFLEX ESOPHAGEAL PROXIMAL RELEASE STENT DEPLOYMENT SUTURE WAS KNOTTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6541370 ↗