WallFlex™ Esophageal M00516740Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729778073), received between Jan 3, 2018 and Nov 20, 2025 — classified as 1 death, 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (9 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-3279-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Difficult to Remove; Device-Device Incompatibility; Positioning Problem; Difficult to Remove; Device-Device Incompatibility; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE GASTROESOPHAGEAL JUNCTION TO TREAT A MALIGNANT DISTAL STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE ESOPHAGEAL STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE PHYSICIAN DROVE A GASTROSCOPE THROUGH THE STENT CAUSING IT TO DISLODGE DISTALLY INTO THE STOMACH. THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY 1 HOUR AS ATTEMPTS TO RETRIEVE THE STENT USING SNARES AND RAT TOOTH FORCEPS WERE MADE. DESPITE THE EFFORTS, THE DEVICE WAS NOT ABLE TO BE RETRIEVED; THE PHYSICIAN IS GOING TO SCHEDULE A FUTURE PROCEDURE TO REMOVE IT EVENTUALLY. THE PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER WALLFLEX STENT. THE PATIENT'S CONDITION WAS STABLE AFTER THE PROCEDURE. 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 23607546 ↗
• MalfunctionJan 23, 2025Difficult 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 A 5CM STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) ESOPHAGEAL STENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT ANATOMY WAS NOTED TO BE TORTUOUS. DURING THE WITHDRAWAL, AFTER THE STENT DEPLOYED IT WAS CAUGHT ON THE DELIVERY SYSTEM. THEY ADJUSTED AND RECAPTURED SHEATH. ANOTHER WALLFLEX ESOPHAGEAL FULLY COVERED STENT 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 21218619 ↗
• InjuryDec 31, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGO-GASTRIC JUNCTION (OGJ) TO TREAT AN APPROXIMATELY 6CM MALIGNANT STRICTURE DURING A 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 DEPLOYED, AND THE DELIVERY SYSTEM WAS REMOVED; HOWEVER, IT WAS NOTED THAT THE STENT WAS PLACED PROXIMAL TO THE STRICTURE. SUBSEQUENTLY, THE STENT WAS PUSHED DOWN USING A GRASPER, BUT IT WAS UNSUCCESSFUL. THE STENT WAS THEN REMOVED WITH THE SAME GRASPER. THE PROCEDURE WAS CANCELLED AS THE PHYSICIAN DECIDED NOT TO PLACE ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048435 ↗
• MalfunctionJul 17, 2024Failure to Advance; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT ESOPHAGEAL STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE DELIVERY SYSTEM ENCOUNTERED DIFFICULTY IN ADVANCING THROUGH THE STRICTURE. THE DEVICE WAS REMOVED; HOWEVER, THE TIP OF THE CATHETER BROKE. THE TIP WAS ON THE WIRE, AND IT WAS REMOVED WITH THE HELP OF THE WIRE. THE DELIVERY SYSTEM WAS REMOVED, AND ANOTHER WALLFLEX ESOPHAGEAL 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 19765006 ↗
• InjuryJul 15, 2024Positioning Failure; Use of Device Problem; Detachment of Device or Device Component; Positioning Failure; 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 USED TO TREAT AN ESOPHAGEAL LEAK DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WHITE TIP DISLODGED FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746331 ↗
• InjuryMay 6, 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 ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE WHITE TIP OF THE DEVICE WAS DETACHED. THE DETACHED TIP WAS THEN REMOVED USING A NET, AND ANOTHER WALLFLEX ESOPHAGEAL 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 19249524 ↗
• MalfunctionApr 10, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use 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 ESOPHAGEAL CANCER DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WHITE TIP OF THE DEVICE WAS DISCONNECTED. THE DELIVERY SYSTEM AND TIP WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082251 ↗
• InjuryMar 25, 2024Break; Difficult to Remove; Use of Device Problem; Migration; Break; Difficult to Remove; Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT RMV WAS IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING A STENT REMOVAL PROCEDURE, THE STENT WAS ATTEMPTED TO BE REMOVED, HOWEVER, THE STENT SUTURE LOOP FELL OFF. THE STENT WAS THEN NOTED TO HAVE MIGRATED TO THE STOMACH. THE MIGRATED STENT WAS REMOVED USING A SNARE 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 18969677 ↗
• InjuryJan 4, 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 MID ESOPHAGUS TO TREAT A 2CM LONG MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS ADVANCED THROUGH THE LESION; HOWEVER, THE TIP GOT STUCK IN THE TUMOR AND GOT DETACHED WHEN THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED. THE TIP WAS REMOVED FROM THE PATIENT USING A RAT TOOTH FORCEPS AND ANOTHER WALLFLEX ESOPHAGEAL STENT 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 18448680 ↗
• InjuryAug 16, 2023Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A 2-3 CM MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6), 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE PATIENT HAD CHEMOTHERAPY, AND ON (B)(6) 2023, DURING A FOLLOW-UP VISIT, AN X-RAY SCAN REVEALED THAT THE STENT MIGRATED. THE PATIENT'S STRICTURE WAS PARTIALLY RESOLVED AT THE TIME OF MIGRATION AND ON (B)(6) 2023, THE STENT WAS REMOVED USING RAT TOOTH FORCEPS AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558393 ↗
• InjuryMar 7, 2023Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 17, 2023, THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT EXTRINSIC STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. ON (B)(6) 2023, POST STENT PLACEMENT, THE PATIENT BEGAN EXPERIENCING DYSPHAGIA WHICH PROMPTED THE PHYSICIAN TO CHECK ON THE STATUS OF STENT PLACEMENT. IT WAS NOTED THAT THE STENT HAD MIGRATED TO THE STOMACH. THE WALLFLEX ESOPHAGEAL STENT REMAINED IMPLANTED, AND ANOTHER PARTIALLY COVERED STENT WAS IMPLANTED. THE PATIENT WAS SCHEDULED TO RETURN FOR THE REMOVAL OF THE MIGRATED STENT ON (B)(6) 2023. THERE WERE NO REPORTED PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 16497856 ↗
• MalfunctionFeb 8, 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 USED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE WALLFLEX ESOPHAGEAL STENT WAS UNABLE TO COMPLETELY DEPLOY DESPITE MULTIPLE ATTEMPTS AND SWITCHING OF ANGLES AND POSITIONS. THE WALLFLEX ESOPHAGEAL STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329133 ↗
• InjuryMar 15, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE DISTAL ESOPHAGUS/GASTROESOPHAGEAL JUNCTION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TIGHT AND THE STRICTURE WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, IT WAS NOTED VIA GASTROSCOPE THAT THE PROXIMAL END OF THE STENT WAS IN THE STOMACH. THE STENT REMAINED IMPLANTED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN PLANNED TO REMOVE THE STENT ON (B)(6) 2022 AND POTENTIALLY PLACE ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776557 ↗
• InjuryJun 17, 2021Difficult to Remove; Use of Device Problem; Positioning Problem; Difficult to Remove; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 26, 2021 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A LEAK IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, A PORTION OF THE DELIVERY SYSTEM GOT CAUGHT ON THE STENT AND THE STENT WAS PULLED PROXIMAL. THE STENT WAS ATTEMPTED TO BE REPOSITIONED DISTALLY USING FORCEPS BUT THE STENT WAS UNABLE TO ADVANCE TO ITS TARGET LOCATION. THE STENT WAS REMOVED FROM THE PATIENT AND ANOTHER WALLFLEX ESOPHAGEAL WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A LEAK IN THE ESOPHAGUS. HOWEVER, PER WALLFLEX ESOPHAGEAL FULLY COVERED 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, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS. THE WALLFLEX ESOPHAGEAL FULLY CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12017467 ↗
• InjuryAug 27, 2020Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 06, 2020 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A GASTRIC BYPASS ANASTOMOTIC STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, ABOUT TWO WEEKS POST STENT PLACEMENT, THE PATIENT CONTACTED THE PHYSICIAN AND COMPLAINED OF NAUSEA. REPORTEDLY, THE PATIENT WAS SCHEDULED FOR AN EMERGENT FOLLOW-UP THE NEXT DAY. X-RAY WAS OBTAINED AND CONFIRMED THAT THE STENT HAD MIGRATED INTO THE JEJUNUM. ON (B)(6) 2020, THE MIGRATED STENT WAS REMOVED FROM THE PATIENT USING RAT TOOTH FORCEPS. REPORTEDLY, IN (B)(6) 2020, A DIFFERENT STENT WAS IMPLANTED. REPORTEDLY, THE NAUSEA IS PROBABLY DUE TO THE STRICTURE. NOTE: ACCORDING TO THE COMPLAINANT, THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A GASTRIC BYPASS ANASTOMOTIC STRICTURE. HOWEVER, PER WALLFLEX ESOPHAGEAL FULLY COVERED 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, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS. ADDITIONALL

  Patient problems: Nausea; No Code Available

  MAUDE report 10460654 ↗
• DeathApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A FOCAL, FRIABLE, POST RADIATION STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON THE END OF (B)(6) 2019. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. REPORTEDLY, THE PATIENT HAD ESOPHAGEAL CANCER AND WAS UNDERGOING RADIATION THERAPY, THE MUCOSA WAS FRIABLE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2020, BLEEDING AT THE SITE OF THE STENT FLARE WAS CONFIRMED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT, THE STENT AND THE FRIABLE MUCOSA OF THE PATIENT CAUSED OR CONTRIBUTED TO THE BLEEDING. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND UNDERGONE A COMPUTED TOMOGRAPHY ARTERIOGRAM (CT ARTERIOGRAM). REPORTEDLY, THE PATIENT PASSED AWAY ON (B)(6) 2020 DUE TO BLEEDING COMPLICATIONS. IN THE PHYSICIAN'S ASSESSMENT, THERE WAS SOMEWHAT OF A RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE STENT. THERE WAS NO REPORTED DAMAGE OR DEFICIENCY OF THE STENT.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 9918402 ↗
• InjuryOct 21, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 30, 2019 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED TO TREAT A 4CM BENIGN STRICTURE AT THE LOWER ESOPHAGEAL SPHINCTER (LES) DURING AN ESOPHAGEAL DILATION WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. REPORTEDLY, THE PHYSICIAN WANTED TO PLACE A STENT INSTEAD OF BRINGING THE PATIENT BACK EVERY FEW WEEKS FOR DILATION. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED NORMALLY AT THE CORRECT ANATOMY LOCATION; HOWEVER, THAT THE STENT "JUMPED UP" INTO THE UPPER ESOPHAGEAL SPHINCTER (UES) AFTER IT WAS DEPLOYED. THE STENT WAS REMOVED WITH A RAT TOOTH FORCEPS. REPORTEDLY, THE PHYSICIAN COMPLETED THE PROCEDURE BY USING A DILATION BALLOON CATHETER TO DILATE THE STRICTURE WITHOUT PLACING ANOTHER 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 Consequences Or Impact To Patient

  MAUDE report 9214318 ↗
• InjuryFeb 27, 2019Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A 5CM MALIGNANT MASS IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD 2 ROUNDS OF RADIATION POST STENT PLACEMENT. ON (B)(6) 2019, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH PAIN. A CHEST X-RAY WAS PERFORMED AND IDENTIFIED THE STENT HAD MIGRATED INTO THE STOMACH. REPORTEDLY, THE STRICTURE DID NOT SHRINK IN SIZE. ON (B)(6) 2019 THE PHYSICIAN REMOVED THE STENT WITH RAT TOOTH FORCEPS AND A 23MMX 12CM WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Code Available; Pain

  MAUDE report 8375479 ↗
• InjuryFeb 27, 2019Difficult to Remove; Use of Device Problem; Positioning Problem; Activation Failure; Difficult to Remove; Use of Device Problem; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED TO TREAT A POST SURGICAL ANASTOMOTIC LEAK IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. 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 ABLE TO BE DEPLOYED ACROSS THE ANASTOMOTIC SECTION. HOWEVER, THE DISTAL FLANGE OF THE STENT WAS NOT FULLY EXPANDED AND IT APPEARED THAT THE DISTAL TIP OF THE DELIVERY SYSTEM WAS HOOKED ONTO THE DISTAL END OF THE STENT. DURING DELIVERY SYSTEM REMOVAL, THE STENT WAS PULLED PROXIMALLY OUT OF POSITION. THE PHYSICIAN DECIDED TO REMOVE THE STENT WITH RAT TOOTH FORCEPS AND A DIFFERENT STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: ACCORDING TO THE COMPLAINANT, THE STENT WAS TO BE USED TO TREAT A POST SURGICAL ANASTOMOTIC LEAK IN THE ESOPHAGUS. PER THE DFU, "THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8375451 ↗
• InjuryMar 1, 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 STENOSIS IN THE CARDIA OF THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED 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 ABLE TO BE DEPLOYED. HOWEVER, WHEN THE STENT WAS VIEWED ENDOSCOPICALLY TO CHECK FOR PLACEMENT, THE STENT WAS NOTED TO HAVE MOVED TOWARDS THE STOMACH DUE TO PERISTALSIS. THE STENT WAS REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH 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 7306124 ↗
• InjuryFeb 28, 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 STENOSIS IN THE CARDIA OF THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED 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 ABLE TO BE DEPLOYED. HOWEVER, WHEN THE STENT WAS VIEWED ENDOSCOPICALLY TO CHECK FOR PLACEMENT, THE STENT WAS NOTED TO HAVE MOVED TOWARDS THE STOMACH DUE TO PERISTALSIS. THE STENT WAS REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH 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 7304649 ↗
• InjuryJan 3, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT AN IATROGENIC PERFORATION IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, THE PATIENT UNDERWENT AN IMAGING PROCEDURE PER PHYSICIAN'S REQUEST TO CHECK THE STENT PLACEMENT AND ENSURE IT HAD NOT MIGRATED. THE STENT WAS FOUND TO HAVE MIGRATED DISTALLY. THE PHYSICIAN USED RAT TOOTH FORCEPS TO REPOSITION THE MIGRATED STENT AND THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 OKAY. ACCORDING TO THE COMPLAINANT, THE STENT WAS USED TO SEAL AN IATROGENIC PERFORATION. HOWEVER, THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM IS ONLY INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7161187 ↗