WallFlex™ Esophageal M00516730Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729778066), received between Oct 29, 2018 and Nov 13, 2025 — classified as 22 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-3278-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Positioning Problem; Activation Failure; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL STRICTURE DURING A PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS OR TIGHT PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN THE ESOPHAGUS WITH THE DISTAL END POSITIONED IN THE STOMACH. UNDER FLUOROSCOPIC OBSERVATION, IT APPEARED THAT THE DISTAL END OF THE STENT FAILED TO FULLY EXPAND. THE PHYSICIAN ATTEMPTED TO RECONSTRAIN THE CATHETER; HOWEVER, THE TIP OF THE DELIVERY SYSTEM ENGAGED THE STENT, CAUSING IT TO MIGRATE PROXIMALLY. GRASPING FORCEPS WERE THEN USED TO REPOSITION THE STENT, AT WHICH POINT IT APPEARED THAT THE STENT HAD FULLY EXPANDED. THE PROCEDURE WAS COMPLETED WITH THE MIGRATED STENT REMAINING IN PLACE, AND IT WAS REPORTED THAT THE STENT WILL BE REMOVED AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 23543367 ↗
• InjuryMay 27, 2025Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE WALLFLEX ESOPHAGEAL STENTS WAS TO BE IMPLANTED TO MALIGNANT STRICTURE DURING A GASTROSCOPY WITH ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS PLACED AND WAS DEPLOYED DISTALLY BEYOND THE STRICTURE. THE STENT WAS DIFFICULT TO REMOVE AS THE STRICTURE WAS TOO TIGHT. THE PROCEDURE COMPLETED USING AN ALTERNATE DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091398 ↗
• InjuryOct 25, 2024Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND HAD NOT BEEN DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT JUMPED UPON DEPLOYMENT AND MOVED INTO THE STOMACH. THE STENT COULD NOT BE REMOVED FROM THE PATIENT AND WAS LEFT IN THE STOMACH. THE PROCEDURE WAS RESCHEDULED, AND A FEEDING TUBE WAS PLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 25, 2024. IT WAS FURTHER REPORT THAT THE STENT WAS PLACED DURING A DISTAL ESOPHAGEAL STENT PLACEMENT PROCEDURE. THE STENT WAS UNABLE TO BE REMOVED DUE TO THE TIGHTNESS OF THE STRUCTURE. A RAT TOOTH WAS USED TO PUSH THE STENT INTO THE STOMACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537438 ↗
• InjurySep 23, 2024Difficult to Remove; Use of Device Problem; Activation Failure; Difficult to Remove; Use of Device Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE MID ESOPHAGUS TO TREAT A BENIGN ESOPHAGEAL STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH 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 ABLE TO BE DEPLOYED. HOWEVER, UNDER FLUOROSCOPIC VIEW, IT WAS NOTED THAT THE DISTAL END OF THE STENT DID NOT FULLY EXPAND. DURING REMOVAL OF THE STENT DELIVERY SYSTEM, THE TIP OF THE DELIVERY SYSTEM GOT CAUGHT ON THE DISTAL FLANGES OF THE STENT, WHICH CAUSED THE STENT TO BE REMOVED UNINTENTIONALLY. THE STENT WAS EVENTUALLY REMOVED USING RETRIEVAL FORCEPS, AND THE PROCEDURE WAS COMPLETED USING ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: ACCORDING TO THE COMPLAINANT, THERE WAS NO MALIGNANCY AT THE INTENDED ANATOMY. HOWEVER, PER THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279766 ↗
• MalfunctionSep 18, 2024Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT, PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PROXIMAL STENT WOULD NOT OPEN/EXPAND FULLY AFTER DEPLOYMENT. THE STENT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249877 ↗
• InjuryJul 30, 2024Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED TO TREAT AN ANASTOMOTIC LEAK IN THE ESOPHAGUS, MID-DISTAL AT THE ANASTOMOTIC SITE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. A PORTION OF THE PATIENT'S ANATOMY WAS TORTUOUS, ALTHOUGH NOT SEVERELY, AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. FLUOROSCOPY REVEALED THAT THE DISTAL TIP HAD DETACH FROM THE DELIVERY SYSTEM. CONSEQUENTLY, THE STENT WAS REMOVED, AND THE DETACHED TIP WAS ALSO SUCCESSFULLY REMOVED USING RETRIEVAL FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19868399 ↗
• InjuryJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE STOMACH TO TREAT A MALIGNANT ESOPHAGEAL STRICTURE DURING A 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 SUCCESSFULLY DEPLOYED. HOWEVER, THE WHITE TIP WAS DETACHED WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. THE DETACHED TIP WAS REMOVED USING RAT TOOTH FORCEPS, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610512 ↗
• MalfunctionJun 12, 2024Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT ESOPHAGEAL STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, UPON DEPLOYING THE STENT, IT WAS NOTED THAT THERE WAS NO MESH INSIDE THE DELIVERY CATHETER. SUBSEQUENTLY, THERE WAS NO PROSTHESIS AFTER THE RELEASE PROCESS. 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 19522752 ↗
• InjuryJun 5, 2024Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE TIP OF THE DELIVERY SYSTEM DETACHED. THE DETACHED TIP WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473262 ↗
• MalfunctionApr 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT ANASTOMOTIC LEAK DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, THE TIP FELL OFF THE DELIVERY SYSTEM OUTSIDE OF PATIENT PRIOR TO INSERTION OF THE DEVICE INTO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19035795 ↗
• MalfunctionMar 27, 2024Use of Device Problem; Detachment of Device or Device Component; Material Deformation; Use of Device Problem; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED IN THE GASTROESOPHAGEAL JUNCTION TO TREAT A POST-SURGICAL LEAK DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH 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, WHILE LOADING THE STENT OVER THE GUIDEWIRE, THE WHITE RUBBER CONE AT THE END OF THE STENT WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE WALLFLEX ESOPHAGEAL STENT WAS USED TO TREAT A POST-SURGICAL LEAK. 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 ESOPHAGEAL FISTULAS. THE DEVICE IS NOT INDICATED FOR THE TREATMENT OF LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986098 ↗
• InjuryMar 1, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DURING AN UPPER GASTROINTESTINAL (GI) ENDOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. ON (B)(6) 2023, THE PATIENT PRESENTED WITH WORSENING DYSPHAGIA, WHICH HAD STARTED TWO WEEKS PRIOR TO THE PROCEDURE. UPON CHECKING, IT WAS NOTED THAT THE STENT HAD DISTAL PARTIAL MIGRATION DUE TO STRICTURE RESOLUTION. SUBSEQUENTLY, THE STENT WAS REPOSITIONED, AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2023, THE PATIENT PASSED AWAY. THE CLINICAL CAUSE OF THE PATIENT'S DEATH WAS A MALIGNANT ESOPHAGEAL NEOPLASM.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18821342 ↗
• InjuryFeb 29, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A 5CM MALIGNANT STRICTURE DURING AN UPPER GASTROINTESTINAL (GI) ENDOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT PROCEDURE. ON (B)(6) 2022, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH FOOD IMPACTION. UPON CHECKING, IT WAS NOTED THAT THE STENT HAD COMPLETELY MIGRATED DISTALLY DUE TO THE STRICTURE RESOLUTION. SUBSEQUENTLY, THE STENT WAS REMOVED USING GRASPERS AND THE PROCEDURE WAS COMPLETED. **ADDITIONAL INFORMATION RECEIVED ON MARCH 01, 2024** POST-STENT PLACEMENT, THE PATIENT'S DYSPHAGIA INITIALLY IMPROVED. HOWEVER, THE PATIENT BEGAN TO DEVELOP WORSENING DYSPHAGIA OVER TIME.

  Patient problems: Dysphagia/ Odynophagia; Insufficient Information

  MAUDE report 18813013 ↗
• InjuryFeb 29, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STENOSIS DURING AN UPPER GASTROINTESTINAL ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE STENT WAS ABLE TO BE DEPLOYED SATISFACTORILY. ON (B)(6) , AN X-RAY WAS PERFORMED DUE TO THE PATIENT'S ONGOING ASPIRATION PNEUMONIA AND ABDOMINAL PAIN, AND IT WAS NOTED THAT THERE WAS TISSUE IN GROWTH IN THE STENT. THE STENT WAS REMOVED, AND ANOTHER STENT WAS IMPLANTED ON THE SAME DAY. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022, AND DISCHARGED ON OCTOBER 13, 2022. IN THE PHYSICIAN'S ASSESSMENT, THE STENT UNLIKELY CAUSED THE PNEUMONIA. HOWEVER, SINCE THE PATIENT HAS ESOPHAGEAL CANCER AND SOME OTHER ONGOING MEDICAL COMPLICATIONS, IT IS UNKNOWN IF THE STENT CAUSED OR CONTRIBUTED TO THE PATIENT'S COMPLICATIONS.

  Patient problems: Abdominal Pain; Pneumonia

  MAUDE report 18810916 ↗
• InjuryFeb 29, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT AN 8CM MALIGNANT STRICTURE DURING AN UPPER GASTROINTESTINAL (GI) ENDOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. ON (B)(6) 2023, POST-STENT PLACEMENT, THE PATIENT PRESENTED WITH DYSPHAGIA. UPON CHECKING, IT WAS NOTED THAT THE STENT HAD PARTIALLY MIGRATED PROXIMALLY. THE STENT WAS REPOSITIONED USING ALLIGATOR FORCEPS AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18810913 ↗
• InjuryFeb 29, 2024Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT OBSTRUCTIVE ESOPHAGEAL TUMOR DURING AN UPPER GASTROINTESTINAL ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT WAS SCHEDULED FOR CRYOTHERAPY FOR AN ESOPHAGEAL TUMOR, AND IT WAS NOTICED DURING THE PROCEDURE THAT THE STENT HAD COMPLETELY MIGRATED TO THE DISTAL PART OF THE ANATOMY. ON THE SAME DAY, THE STENT WAS ADJUSTED AND RE-SUTURED IN PLACE USING THE APOLLO OVERSTITCH. ON (B)(6) 2022, THE STENT WAS REMOVED FROM THE PATIENT USING GRASPERS. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED DYSPHAGIA. NOTE: IT WAS REPORTED THAT THE STENT WAS RE-SUTURED IN PLACE USING THE APOLLO OVERSTITCH. ALTHOUGH SUTURING THE STENT IS A DOCUMENTED PRACTICE IN CLINICAL LITERATURE, IT IS NOT IN THE LABELING.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18810778 ↗
• InjuryNov 17, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN APPROXIMATELY 4CM MALIGNANT STRICTURE DURING A 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, AFTER THE STENT DEPLOYMENT, IT WAS CONFIRMED THROUGH IMAGING THAT THE STENT HAD MIGRATED. THE STENT WAS REMOVED USING GRASPER AND A LONGER 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 18161858 ↗
• MalfunctionApr 28, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH 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 UNSHEATHED FROM THE DELIVERY SYSTEM. THE WALLFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. ANOTHER WALLFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 16835602 ↗
• InjuryApr 26, 2023Difficult or Delayed Positioning; Positioning Problem; Difficult or Delayed Positioning; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WAS DIFFICULTY DEPLOYING THE STENT. THE PHYSICIAN PULLED HARDER, AND THE STENT EVENTUALLY FULLY DEPLOYED; HOWEVER, THE STENT DEPLOYED OUTSIDE THE STRICTURE. THE STENT WAS REMOVED USING A RESCUE COMBO RAT TOOTH/ALLIGATOR FORCEPS AND ANOTHER 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 16820117 ↗
• MalfunctionFeb 8, 2023Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL TUMOR DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION AND OUTSIDE THE PATIENT, THE OUTER BOX WAS FOUND BENT. THE INNER STERILE POUCH WAS PUNCTURED UPON INSPECTION. ANOTHER WALLFLEX ESOPHAGEAL STENT OF A DIFFERENT MODEL WAS IMPLANTED 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 16329326 ↗
• InjurySep 30, 2022Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE MID-ESOPHAGUS TO TREAT A BENIGN STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN MISDEPLOYED THE WALLFLEX ESOPHAGEAL STENT; CONSEQUENTLY, THE WALLFLEX ESOPHAGEAL STENT WAS PLACED ABOVE THE STRICTURE. THE WALLFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT WITH RAT-TOOTH GRASPING FORCEPS AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A BENIGN ESOPHAGEAL STRICTURE. PER THE INSTRUCTIONS FOR USE (IFU), "THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS". THE STENT IS NOT INDICATED FOR THE TREATMENT OF BENIGN STRICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15512011 ↗
• MalfunctionFeb 3, 2022Difficult or Delayed Positioning; Premature Activation; Difficult or Delayed Positioning; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE STENT FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH AND ATTEMPTED TO DEPLOY THE STENT PARTIALLY OUTSIDE OF THE PATIENT; HOWEVER, THE STENT PREMATURELY FULLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446624 ↗
• InjuryJun 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A 2 CM BENIGN REFRACTORY ESOPHAGEAL STRICTURE 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. ON (B)(6) 2021, DURING A ROUTINE FOLLOW-UP, AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED AND IT WAS NOTED THAT A PATCH OF ABOUT SIX CELLS ON THE STENT COVER WERE DAMAGED. REPORTEDLY, THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050444 ↗
• InjuryOct 8, 2020Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A 3CM MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT 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, TWO DAYS AFTER THE STENT PLACEMENT DURING A ROUTINE FOLLOW-UP PROCEDURE, A NASOGASTRIC TUBE WAS PLACED AND IT WAS NOTED UNDER KIDNEY, URETER, BLADDER (KUB) IMAGING THAT THE STENT HAD MIGRATED. ON (B)(6) 2020, AN EGD PROCEDURE WAS PERFORMED AND THE STENT WAS REPOSITIONED WITH RAT TOOTH FORCEPS AND SUTURED IN PLACE. THE STENT REMAINS IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH ORIGINAL 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 FINE.

  Patient problems: No Code Available

  MAUDE report 10652751 ↗
• InjuryJul 23, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A 6 CM MALIGNANT STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) 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 WAS DEPLOYED AND MOVED INTO THE STOMACH. REPORTEDLY, THE STENT WAS UNABLE TO BE REMOVED. ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT WILL BE SCHEDULED FOR STENT REMOVAL OF THE MISPOSITIONED STENT; HOWEVER, DUE TO COVID-19, THE EXACT DATE IS UNKNOWN. 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 Code Available

  MAUDE report 10317080 ↗