WallFlex™ Esophageal M00516750Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729778080), received between Mar 17, 2017 and May 22, 2024 — classified as 1 death, 12 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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-3280-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 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 TO BE IMPLANTED TO TREAT A GASTRECTOMY LEAK OF THE GASTROESOPHAGEAL (GE) JUNCTION DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE DEVICE BROKE OFF WHEN THE DEVICE WAS INSERTED AT THE GE JUNCTION. THE TIP EVENTUALLY FELL INTO THE ABDOMINAL CAVITY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT ESOPHAGEAL STENT. 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 19376796 ↗
• MalfunctionApr 30, 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 A STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE TIP OF THE STENT WAS DETACHED OUTSIDE THE PATIENT'S BODY. A DIFFERENT DEVICE 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 19215782 ↗
• MalfunctionMar 26, 2024Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, THE STENT AND ITS PACKAGING WAS NOTED TO BE DAMAGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18981428 ↗
• DeathJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2023-06992 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6)2023. ON (B)(6) 2023, A SECOND WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO REINFORCE THE CLOSURE OF THE FISTULA. ON AN UNKNOWN DATE, POST-STENT PLACEMENT OF THE SECOND WALLFLEX ESOPHAGEAL STENT, THE PATIENT PASSED AWAY. THE RELATIONSHIP BETWEEN THE WALLFLEX ESOPHAGEAL STENTS AND THE PATIENT'S DEATH IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18451143 ↗
• InjuryJun 23, 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 4-5 CM MALIGNANT ESOPHAGEAL STRICTURE DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT'S ANATOMY WAS NOT TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2023, THE PATIENT PRESENTED WITH PAIN. IMAGING TEST SHOWED THE STENT MIGRATED INTO THE STOMACH AND FORMATION OF AN ULCER WAS NOTED AT THE DISTAL PORTION OF THE STENT THAT TURNED INTO A PERFORATION. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED, AND THE STENT WAS REMOVED FROM THE PATIENT WITH RESCUE COMBO FORCEPS. THE STRICTURE WAS REPORTED TO BE RESOLVED AT THE TIME OF MIGRATION. THE PHYSICIAN ATTEMPTED TO CLOSE THE PERFORATION WITH MANTIS CLIPS, BUT THE TISSUE WAS TOO FRIABLE, AND THE CLIPS WOULD NOT GRASP ON TO THE TISSUE. THE PROCEDURE WAS NOT COMPLETED, AND THE PERFORATION WAS NOT CLOSED. CLOSURE OF THE PERFORATION WAS SCHEDULED FOR THE NEXT 7-10 DAYS.

  Patient problems: Pain; Perforation; Ulcer

  MAUDE report 17189939 ↗
• InjuryDec 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE WHITE OLIVE TIP WAS DETACHED FROM THE DELIVERY SYSTEM AND FELL INTO THE STOMACH. THE WALLFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT AND THE DETACHED TIP WAS RETRIEVED WITH A RETRIEVAL NET. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. 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 16019361 ↗
• MalfunctionSep 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 23, 2021 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, THE WHITE DILATION TIP OF THE DELIVERY SYSTEM DETACHED OUTSIDE 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 12466676 ↗
• InjuryAug 28, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE ATTEMPTED STENT DEPLOYMENT, THE STENT WAS MISFIRED. REPORTEDLY, THE MISFIRED STENT WAS REMOVED FROM THE PATIENT AND A SHORTER STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: DESPITE EFFORTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10466912 ↗
• InjuryApr 16, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED TO TREAT A 13 CM MALIGNANT STRICTURE IN THE ESOPHAGUS 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, THE STENT WAS UNINTENTIONALLY DEPLOYED IN AN INCORRECT LOCATION. THE STENT WAS REMOVED FROM THE PATIENT WITH GRASPER FORCEPS AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS PLACED 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968478 ↗
• InjuryOct 3, 2019Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  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 5MM ESOPHAGEAL FISTULA DURING AN ESOPHAGEAL PROSTHESIS PLACEMENT PROCEDURE PERFORMED IN (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS FULLY RELEASED FROM THE DELIVERY SYSTEM; HOWEVER, WHEN THE PHYSICIAN PULLED THE STENT CATHETER OUT FROM THE PATIENT, THE DELIVERY SYSTEM GOT STUCK ON THE PROXIMAL END OF THE STENT, AND THE STENT MOVED OUT FROM ITS TARGET LOCATION. THE STENT WAS REMOVED WITH BIOPSY FORCEPS AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS PLACED 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9150376 ↗
• InjuryAug 29, 2019Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 6, 2019 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED IN THE ESOPHAGUS TO TREAT POST GASTRIC SLEEVE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WOULD NOT DEPLOY ON THE FIRST ATTEMPT. ON THE SECOND ATTEMPT, THE DEVICE WAS WITHDRAWN UP CLOSER AND THE STENT WAS ABLE TO BE DEPLOYED, HOWEVER; THE STENT WAS PLACED A LITTLE HIGHER FROM THE TARGET STRICTURE. REPORTEDLY, THE PHYSICIAN WAS NOT HAPPY ON THE LOCATION OF THE STENT. THE STENT WAS REMOVED FROM THE PATIENT AND NO OTHER STENT WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: ACCORDING TO THE COMPLAINANT, THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED TO TREAT POST GASTRIC SLEEVE. PER THE WALLFLEX ESOPHAGEAL STENT DIRECTIONS FOR USE (DFU), THE WALLFLEX ESOPHAGEAL 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. ADDITIONAL INFORMATION RECEIVED ON

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8945983 ↗
• InjuryMay 23, 2019Break; Migration; Break; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019 FIVE DAYS POST STENT PLACEMENT, THE PATIENT PRESENTED WITH DYSPHAGIA. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED AND NOTICED THAT THE STENT HAD MIGRATED INTO THE STOMACH. THE STENT WAS REMOVED FROM THE PATIENT BY GRABBING THE STENT SUTURE WITH A RAPTOR FORCEPS. REPORTEDLY, THE STENT SUTURE BROKE. THE PROCEDURE WAS COMPLETED BY IMPLANTING A DIFFERENT STENT. 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: Dysphagia/ Odynophagia; No Code Available

  MAUDE report 8637663 ↗
• InjuryOct 25, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 29, 2018 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FELL INTO THE STOMACH RIGHT AFTER IT WAS DEPLOYED IN THE ESOPHAGUS. THE STENT WAS REMOVED WITH FORCEPS AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS PLACED 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 Consequences Or Impact To Patient

  MAUDE report 8004990 ↗
• MalfunctionOct 24, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. DURING CATHETER REMOVAL, THE DELIVERY SYSTEM SNAGGED ON THE STENT, AND THE STENT WAS PULLED OUT FROM THE PATIENT TOGETHER WITH THE DELIVERY SYSTEM. THE PHYSICIAN USED ANOTHER WALLFLEX ESOPHAGEAL STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001000 ↗
• InjuryJul 24, 2018Migration or Expulsion of Device; Activation Failure; Migration or Expulsion of Device; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6 2018 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A STRICTURE IN 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, THE STENT WAS SUCCESSFULLY IMPLANTED. ON THE SAME DAY, POST PROCEDURE, IT WAS NOTED THAT THE STENT HAD NOT FULLY EXPANDED AND HAD MIGRATED. REPORTEDLY, THE PHYSICIAN WAS NOT COMFORTABLE LEAVING THE STENT IN PLACE. THE MIGRATED STENT WAS REMOVED FROM THE PATIENT WITH AN UNKNOWN DEVICE 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 AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7715439 ↗
• InjuryJun 14, 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 WAS IMPLANTED TO TREAT A 5-6 CM BENIGN PEPTIC STRICTURE IN THE STOMACH NEAR THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS VERY TIGHT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, POST STENT PLACEMENT, THE PATIENT PRESENTED WITH DYSPHAGIA. AN X-RAY WAS PERFORMED TO CHECK FOR STENT PLACEMENT, AND NOTED THE STENT HAD MIGRATED. ON (B)(6) 2018, THE STENT WAS REMOVED WITH FORCEPS DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE. REPORTEDLY, THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT REMOVAL. 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: Dysphagia/ Odynophagia

  MAUDE report 7602048 ↗
• InjuryMay 24, 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 HAD BEEN IMPLANTED TO TREAT APPROXIMATELY 7CM BENIGN PEPTIC ESOPHAGEAL STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE PATIENT PRESENTED WITH DYSPHAGIA. THE PATIENT UNDERWENT A PLANNED STENT REMOVAL DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE AND NOTED THE STENT HAD MIGRATED INTO THE STOMACH. THE STENT WAS REMOVED WITH A RAT TOOTH FORCEPS. ON (B)(6) 2018, ANOTHER STENT WAS IMPLANTED WITHIN THE STRICTURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542636 ↗
• InjuryJun 7, 2017Positioning Problem; Appropriate Device Problem Term/Code Not Available; Positioning Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2017 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A 2 TO 3CM TRACHEOESOPHAGEAL FISTULA DUE TO ESOPHAGEAL VARICES BLEEDING DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT DID NOT HAVE A CONCURRENT MALIGNANT STRICTURE AT THE SITE OF STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED BUT IT ENDED UP IN THE WRONG LOCATION. REPORTEDLY, THE STENT DID NOT COVER THE ENTIRE FISTULA AND THE PHYSICIAN FELT THAT THE STENT WAS SHORTER THAN THE LABELED LENGTH. THE STENT LENGTH WAS MEASURED USING A GUIDEWIRE PRIOR TO THE PROCEDURE. THE STENT REMAINED IMPLANTED AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED (STENT-IN-STENT) TO COVER THE FISTULA AND 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6617785 ↗
• MalfunctionMar 17, 2017Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 23, 2017 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED IN THE DISTAL ESOPHAGUS TO TREAT AN 8CM TRACHEOESOPHAGEAL FISTULA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED DEPLOYING THE STENT AND WHEN ONLY ABOUT 2 CM WAS LEFT FOR STENT DEPLOYMENT, THE STENT DEPLOYED PREMATURELY AND WAS PLACED IN THE WRONG LOCATION. THE STENT REMAINS IMPLANTED AND 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6414128 ↗