WallFlex™ Esophageal M00516700Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729778035), received between Jun 21, 2018 and Sep 29, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 1, 2024Open, Classified

   WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

   Z-3275-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940788 ↗
• InjuryOct 3, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT ESOPHAGEAL CANCER WITH 7CM LESION DURING A PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, STENT DISPLACEMENT WAS OBSERVED. IT WAS NOTED THAT THE STENT WAS IMPLANTED IN THE CORRECT POSITION; HOWEVER, THE PATIENT REPORTED DISCOMFORT, AND THE STENT WAS FOUND TO BE SHIFTED. SUBSEQUENTLY, THE STENT WAS REMOVED USING SNARES. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 8, 2025 AND OCTOBER 20, 2025: IT WAS LATER CONFIRMED THAT THE STENT WAS IMPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED DISCOMFORT, AND THE MIGRATED STENT WAS CONFIRMED VIA IMAGING.

  Patient problems: Discomfort

  MAUDE report 23215969 ↗
• InjuryAug 13, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT AN MALIGNANCY IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. THE PATIENT, WHO HAD A STENT PLACED TWO WEEKS AGO FOR MALIGNANT OBSTRUCTION, UNDERWENT FOLLOW-UP ENDOSCOPY. DURING THE PROCEDURE, THE PHYSICIAN IDENTIFIED EARLY TISSUE INGROWTH AT THE STENT SITE, WHICH WAS CONCERNING GIVEN THE SHORT TIME SINCE PLACEMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798609 ↗
• InjuryAug 7, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT TUMOR IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COVER BROKE POST-DEPLOYMENT, CAUSING THE TISSUE TO SQUEEZE THE MESH INTO THE STENT WHILE THE STENT COVER REMAINED ATTACHED. SUBSEQUENTLY, THE STENT WAS REMOVED USING SNARES. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION ON SEPTEMBER 27, 2025: IT WAS LATER CONFIRMED THAT THE TUMOR IS MALIGNANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745370 ↗
• InjurySep 16, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A BENIGN TUMOR DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, UPON REMOVING THE DELIVERY SYSTEM, THE TIP FELL OFF THE DELIVERY SYSTEM. SUBSEQUENTLY, THE TIP WAS RETRIEVED WITH A NET. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. REPORTEDLY, ON AN UNKNOWN DATE, A FEW DAYS POST-STENT PLACEMENT, THE PATIENT PASSED AWAY. THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS VERY ILL AND DID NOT BELIEVE THE WALLFLEX ENTERAL STENT WAS RELATED TO THE DEATH. ADDITIONALLY, THE PATIENT WAS INCREDIBLY ILL AND ON A BALLOON PUMP FOR THEIR HEART. NOTE: IT WAS REPORTED THAT THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A BENIGN TUMOR. HOWEVER, PER THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, AND OCCLUSION OF CONCURRENT ESOPH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20230605 ↗
• InjuryApr 18, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT IMPLANTED IN THE ESOPHAGUS TO TREAT A STRICTURE DURING AN UPPER GASTROINTESTINAL (GI) ENDOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. ON (B)(6) 2023, THE PATIENT WAS UNABLE TO EAT AND PRESENTED TO THE EMERGENCY ROOM. UPPER GI ENDOSCOPY WAS PERFORMED, AND IT WAS NOTED THAT THE STENT MIGRATED INTO THE STOMACH. THE MIGRATION WAS DUE TO STRICTURE RESOLUTION; HOWEVER, THE PATIENT WAS STILL EXPERIENCING PAIN AND DYSPHAGIA. SUBSEQUENTLY, THE STENT WAS REMOVED USING GRASPERS AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 19130280 ↗
• MalfunctionMar 3, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 14, 2023, THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE LOWER ESOPHAGUS TO TREAT A MALIGNANT ESOPHAGEAL STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN 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 STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. 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 16481691 ↗
• InjurySep 28, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 06, 2022 THAT A WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A 1.5 CM TRACHEOESOPHAGEAL FISTULA DURING ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED FROM THE TEETH TO ESOPHAGUS WITH 20-22 CM DILATION PRIOR TO STENT PLACEMENT. POST STENT PLACEMENT, THE PATIENT EXPERIENCED CHEST PAIN. PAIN MEDICATION WAS ADMINISTERED BUT THE PAIN DID NOT SUBSIDE SO THE PATIENT WAS SCHEDULED FOR A STENT REMOVAL PROCEDURE. ON (B)(6), 2022, DURING STENT REMOVAL PROCEDURE, IT WAS NOTED UNDER ENDOSCOPIC VIEW THAT THE STENT RETRIEVAL LOOP WAS BROKEN. THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN STENT BUT WAS UNSUCCESSFUL BECAUSE THE STENT HAD NO RETRIEVAL LOOP. REPORTEDLY, THE PATIENT PASSED AWAY DUE TO ESOPHAGEAL CANCER.

  Patient problems: Chest Pain

  MAUDE report 15499308 ↗
• MalfunctionAug 8, 2022Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT ESOPHAGEAL STENOSIS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE WALLFLEX ESOPHAGEAL STENT WAS UNABLE TO BE DEPLOYED. THE WALLFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX 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 RESULT WHICH REVEALED THE TIP OF THE WALLFLEX ESOPHAGEAL DELIVERY SYSTEM WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188433 ↗
• InjuryJun 10, 2022Positioning Problem; Migration; Positioning Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT MALIGNANT STRICTURE DUE TO ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, AFTER STENT DEPLOYMENT, IT WAS OBSERVED THAT THE STENT WAS DISPLACED. THE STENT WAS REMOVED AND ANOTHER 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. 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 14654315 ↗
• InjuryOct 18, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A 6CM ESOPHAGEAL CANCER DURING A 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, THE STENT WAS DEPLOYED; HOWEVER, STENT WAS DEPLOYED IN THE INCORRECT POSITION. THE STENT WAS REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX 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

  MAUDE report 12651773 ↗
• InjuryMar 7, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON FEBRUARY 11, 2021 A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A STENOSIS IN THE MIDDLE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. ON (B)(^) 2021, THE PATIENT PRESENTED WITH DYSPHAGIA AND EMERGENCY IMAGING WAS PERFORMED. IT WAS NOTED THAT THE STENT MIGRATED TO THE GASTRIC CHAMBER. THE PATIENT'S ANATOMY WAS DILATED TO 15CM AND THE STENT WAS REMOVED TOGETHER WITH THE THREE CLIPS WHICH THAT WERE INTENDED TO KEEP THE STENT IN PLACE. A NEW STENT WAS NOT PLACED DURING THE PROCEDURE DUE TO THE DILATION SIZE OF THE ANATOMY. RADIOTHERAPY AND QUANTITATIVE MAGNETIZATION (QMT) WERE STARTED TO TREAT THE PATIENT WITH SOME IMPROVEMENTS, AND ANOTHER STENT WILL BE PLACED. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 11426752 ↗
• InjuryMar 3, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A BENIGN STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED TO 15MM PRIOR TO STENT PLACEMENT. DURING A ROUTINE FOLLOW-UP, ON (B)(6) 2021, THE PATIENT REPORTED THAT SHE FELT THAT THE STENT SLIDE DOWN. BARIUM SWALLOW TEST WAS PERFORMED AND IT WAS CONFIRMED THAT THE STENT MIGRATED. THE STENT WAS REMOVED FROM THE PATIENT USING RAT TOOTH FORCEPS. REPORTEDLY, NO OTHER STENT WAS IMPLANTED AND THE STRICTURE HAD NOT RESOLVED AT THE TIME OF MIGRATION. 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 11404241 ↗
• InjuryDec 10, 2020Positioning Failure; Use of Device Problem; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Positioning Failure; Use of Device Problem; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 17, 2020 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL PERFORATION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT 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, AS THE STENT WAS INITIALLY BEING DEPLOYED, THE WHITE CONE-SHAPED TIP DETACHED FROM THE DELIVERY SYSTEM. THE TIP WAS STILL OVER THE WIRE. AN EGD SCOPE WAS ADVANCED AND A RESCUE FORCEPS WAS USED TO RETRIEVE THE TIP AND THE WIRE OUT OF THE PATIENT. THE PROCEDURE WAS NOT COMPLETED AS ANOTHER STENT WAS UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: ACCORDING TO THE COMPLAINANT, THE STENT WAS USED FOR ESOPHAGEAL PERFORATION. HOWEVER, PER WALLFLEX ESOPHAGEAL FULLY COVERED STENT INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULA. THE DEVICE IS NOT INDICATED TO TREAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10983095 ↗
• InjuryMar 20, 2020Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT AN APPROXIMATELY 7CM BENIGN STRICTURE IN THE MID ESOPHAGUS DURING A 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 THE STENT DID NOT FULLY EXPAND. X-RAY WAS PERFORMED AFTER 24 AND 48 HOURS POST STENT PLACEMENT PROCEDURE AND THE STENT STILL DID NOT EXPAND. REPORTEDLY, ON (B)(6) 2020, THE STENT WAS REMOVED AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED 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 Code Available

  MAUDE report 9862736 ↗
• InjuryDec 11, 2018Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT HAS BEEN IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE MID SECTION AND LOWER PART OF THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, DURING A ROUTINE FOLLOW-UP, ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WAS PERFORMED TO REEXAMINE THE STENT AND NOTICED THE STENT HAD MIGRATED INTO THE STOMACH. A SNARE WAS USED TO REPOSITION THE STENT BACK TO ITS ORIGINAL LOCATION. PER THE PHYSICIAN, THE STENT DOES NOT NEED TO BE RETRIEVED OUT FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. REPORTEDLY, THE STRICTURE HAD RESOLVED WHEN THE STENT MIGRATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8153209 ↗
• InjuryNov 9, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE NEAR THE GASTROESOPHAGEAL (GE) JUNCTION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, THE STENT WAS PLACED ACROSS THE GE JUNCTION UNDER FLUOROSCOPIC GUIDANCE. REPORTEDLY, THE PHYSICIAN WENT DOWN WITH THE SCOPE TO VIEW THE STENT ENDOSCOPICALLY, AND NOTICED THE STENT MOVED INTO THE STOMACH. THE STENT WAS REMOVED WITH GRASPING FORCEPS, AND A PARTIALLY COVERED WALLFLEX ESOPHAGEAL STENT WAS PLACED 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 8056970 ↗
• InjuryJun 21, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT HAS BEEN IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, POST STENT PLACEMENT, ON (B)(6) 2018, THE PATIENT UNDERWENT A SCHEDULED GASTROSCOPY PER PROTOCOL TO CHECK FOR STENT PLACEMENT. THE IMAGE REVEALED THE STENT HAD MIGRATED. THE STENT WAS REMOVED WITH FORCEPS AND A SECOND STENT WAS IMPLANTED IN THE SAME LOCATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7627546 ↗