WallFlex™ Duodenal M00565020Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08714729456490), received between Feb 15, 2017 and Sep 17, 2026 — classified as 22 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Premature Activation; Difficult to Advance

  It was reported to Boston Scientific Corporation that a WallFlex Esophageal Stent was attempted to be implanted in the duodenum to treat a duodenal stricture during a Stent placement for duodenal stricture procedure performed on (b)(6) 2026. It was reported that during procedure, the device would not fit down the pediatric colonoscope channel. Due to the tightness of the channel, the stent was inadvertently deployed in the channel. The stent was removed from the patient, and the procedure was completed using another of the same device.There is no patient complications reported as a result of the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803998 ↗
• MalfunctionJul 17, 2026Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX DUODENAL STENT WAS ATTEMPTED TO BE IMPLANTED IN THE INTESTINES DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (b)(6) 2026. DURING THE PROCEDURE WHEN DEPLOYED, THE STENT FELL OFF IN ADVANCE, THE DEPLOYMENT WAS NOT ACCURATE, AND THE THERAPEUTIC EFFECT COULD NOT BE ACHIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25860690 ↗
• MalfunctionMay 7, 2026Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL STENT WAS TO BE IMPLANTED TO TREAT A DUODENAL OBSTRUCTION IN THE DUODENUM DURING AN ENDOSCOPIC INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, BURRS WERE IDENTIFIED AT THE DISTAL END OF THE STENT, AND THE SURFACE OF THE STENT WAS NOT SMOOTH. ALSO, ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE STENT WAS REMOVED IN A PARTIALLY DEPLOYED STATE TOGETHER WITH THE DELIVERY SYSTEM. ANOTHER WALLFLEX ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117983 ↗
• InjuryApr 4, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE USED TO TREAT A 5CM ANATOMIC STRICTURE IN THE DUODENUM CAUSED BY GASTRIC AND DUODENUM CANCER DURING A GASTROSCOPY WITH INTRODUCTION OF DUODENAL STENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT BROKE INTO TWO PARTS. THE BROKEN STENT REMAINS IMPLANTED, AND ANOTHER STENT WAS PLACED THROUGH IT. REPORTEDLY, THE PHYSICIAN DID NOT REMOVE THE STENT DUE TO BLEEDING AND THE ANATOMIC STRICTURE CAUSED BY THE TUMOR. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21775149 ↗
• InjuryJan 22, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED TO TREAT A 2 CM MALIGNANT DUODENAL STENOSIS DURING A COLONOSCOPY WITH DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED IN THE CORRECT LOCATION. HOWEVER, IT WAS REPORTED THAT THE STENT WAS REMOVED FROM THE PATIENT USING RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX DUODENAL STENT. DUE TO THE AMBIGUITY OF THE EVENT, BOSTON SCIENTIFIC CONSIDERED THE WORST-CASE SCENARIO: THE STENT WAS UNABLE TO EXPAND DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21212235 ↗
• MalfunctionJan 9, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED IN THE DUODENUM TO TREAT A 5CM MALIGNANT STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN THE MORE DISTAL PART OF THE STENOSIS INSTEAD OF THE INTENDED LESION SITE. REPORTEDLY, THE STENT WAS SCHEDULED TO BE REMOVED ONE WEEK AFTER THE PROCEDURE. ANOTHER WALLFLEX ENTERAL STENT WAS USED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21119580 ↗
• MalfunctionOct 17, 2024Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT STOMACH CANCER DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. DUE TO PHYSICIAN DISCRETION, IT WAS DECIDED TO TERMINATE THE PROCEDURE WITHOUT PLACING ANY IMPLANT OR DEVICE. REPORTEDLY, THE PATIENT WAS UNDER PALLIATIVE MANAGEMENT AND PASSED AWAY LATER ON AN UNKNOWN DATE DUE TO REASONS NOT RELATED TO THE REPORTED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472235 ↗
• MalfunctionJun 21, 2024Activation Failure; Activation Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-02964 AND 3005099803-2024-02965 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED IN THE GASTRODUODENAL JUNCTION TO TREAT A MALIGNANT STRICTURE AS A PALLIATIVE TREATMENT OF GASTRODUODENAL OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO EXPAND AS MUCH AS THE PHYSICIAN DESIRED. ANOTHER WALLFLEX ENTERAL DUODENAL STENT WAS USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589098 ↗
• MalfunctionJun 20, 2024Activation Failure; Activation Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-02964 AND 3005099803-2024-02965 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED IN THE GASTRODUODENAL JUNCTION TO TREAT A MALIGNANT STRICTURE AS A PALLIATIVE TREATMENT OF GASTRODUODENAL OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO EXPAND AS MUCH AS THE PHYSICIAN DESIRED. ANOTHER WALLFLEX ENTERAL DUODENAL STENT WAS USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575771 ↗
• InjuryMar 19, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX DUODENAL STENT WAS IMPLANTED IN THE DUODENUM TO TREAT A MALIGNANT GASTRODUODENAL STRICTURE DURING AN UPPER GASTROINTESTINAL (GI) ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. ON (B)(6) 2024, AT AN OUTSIDE HOSPITAL (OHS) THE PATIENT PRESENTATION WAS CONSISTENT WITH A SMALL BOWEL OBSTRUCTION RELATED TO A KNOWN DUODENAL OBSTRUCTION AND OCCLUDED STENT. RECOMMENDED TRANSFER FOR ENDOSCOPY TO REPLACE THE DUODENAL STENT. ON (B)(6) 2024, THE PATIENT UNDERWENT UPPER GASTROINTESTINAL (GI) ENDOSCOPY, AND AN ACQUIRED EXTRINSIC STENOSIS WAS FOUND IN THE THIRD PORTION OF THE DUODENUM ASSOCIATED WITH EPITHELIAL INGROWTH RESULTING IN PARTIAL OBSTRUCTION OF THE PROXIMAL PORTION OF THE STENT AND WAS PARTIALLY TRAVERSED USING HYBRID COLONOSCOPE. THE STENT REMAINS IMPLANTED. ADDITIONAL INFORMATION RECEIVED ON MARCH 21, 2024: NASOGASTRIC TUBE (NGT) WAS PLACED WITH 1 LITER OUTPUT GASTRIC CONTENTS WAS DONE TO ADDRESS THE STENT OCCLUSION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18935368 ↗
• InjuryFeb 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED IN THE INTESTINAL TRACT TO TREAT STENOSIS SECONDARY TO METASTASIS OF THE LEFT COLON TUMOR DURING AN ENDOSCOPIC INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS NOTED TO BE BENT AND KINKED AFTER PLACEMENT. SUBSEQUENT REMEDIATION WAS CARRIED OUT. THE STENT WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. ***ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 28, 2024 AND MARCH 20, 2024*** IT WAS REPORTED THAT THE STENT WAS SUCCESSFULLY DEPLOYED AND IMPLANTED INSIDE THE PATIENT WHEN THE STENT WAS FOUND TO BE DEFORMED, BENT, KINKED, AND NOT FULLY DEPLOYED. THE STENT WAS NOT REMOVED FROM THE PATIENT AND A SECOND STENT WAS INSERTED TO HELP KEEP IT DEPLOYED. IT WAS REPORTED THAT SURGERY WILL BE PERFORMED LATER. IN ADDITION, IT WAS REPORTED THAT THE PATIENT HAS ILEUS AND THAT IT IS NOT AN UNDERLYING CONDITION. HOWEVER, THERE IS NO WAS IN

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 18771230 ↗
• InjuryFeb 13, 2024Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED TO TREAT A 5CM MALIGNANT DUODENAL NEOPLASMS DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, IT COULD NOT BE DEPLOYED. THE PHYSICIAN ADJUSTED THE DELIVERY SYSTEM AND MADE ANOTHER ATTEMPT TO DEPLOY THE STENT, BUT THE STENT SUDDENLY FELL OFF AT THE JUNCTION OF RECTUM AND SIGMOID COLON. THE STENT WAS UNABLE TO BE REMOVED AND THE PHYSICIAN IS COMFORTABLE LEAVING THE STENT IN PLACE. ANOTHER WALLFLEX ENTERAL STENT WAS USED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18697172 ↗
• MalfunctionJun 26, 2023Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES TO BE USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2023-03452 AND 3005099803-2023-03453 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 07, 2023, THAT TWO WALLFLEX DUODENAL STENT WAS TO BE USED TO TREAT A 7 MM DUODENAL TUMOR MALIGNANT OBSTRUCTION IN THE DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PROCEDURE, IT WAS NOTED THAT THE INNER STERILE PACKAGING SEAL WAS COMPROMISED (THE SUBJECT OF THIS REPORT). A DIFFERENT SIZE WALLFLEX DUODENAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-03453) WAS OPENED AND THE INNER PACKAGING SEAL WAS ALSO COMPROMISED. A NON-BOSTON SCIENTIFIC 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 17198328 ↗
• InjuryApr 10, 2023Device Stenosis; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED IN THE DUODENUM FOR PALLIATIVE ENDOSCOPIC STENT TREATMENT OF GASTRODUODENAL STRICTURES DURING AN UPPER GASTROINTESTINAL ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND NAUSEA. ON FEBRUARY 28, 2023, THE STENT WAS FOUND OCCLUDED. AN UPPER GASTROINTESTINAL ENDOSCOPY PROCEDURE WAS PERFORMED ON (B)(6)2023, AND A NEW STENT WAS PLACED INSIDE THE ORIGINAL STENT. THE SYMPTOMS WERE RELIEVED, AND THE PATIENT WAS EVENTUALLY DISCHARGED.

  Patient problems: Abdominal Pain; Nausea

  MAUDE report 16708132 ↗
• InjuryFeb 13, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 25, 2023, THAT A WALLFLEX DUODENAL STENT WAS IMPLANTED TO TREAT A DUODENAL NEOPLASM DURING A DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO REPOSITION THE STENT, HOWEVER, THE STENT WAS UNABLE TO BE RE-SHEATHED. THE PHYSICIAN THEN DECIDED TO DEPLOY THE STENT IN AN INCORRECT LOCATION. THE WALLFLEX DUODENAL STENT REMAINS IN PLACE, AND ANOTHER WALLSTENT DEVICE WAS IMPLANTED TO FULLY COVER THE STRICTURE. 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 OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362067 ↗
• MalfunctionDec 8, 2022Break; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Break; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED IN THE DUODENUM TO TREAT A 7CM MALIGNANT EXTRINSIC STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY EVEN AFTER SEVERAL ATTEMPTS AND THE HANDLE CONSEQUENTLY GOT BROKEN. THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHEATH OF THE WALLFLEX ENTERAL STENT WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941257 ↗
• InjuryNov 9, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A 6CM MALIGNANT INTESTINAL STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE WALLFLEX DUODENAL STENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, THE WALLFLEX DUODENAL STENT MOVED OUT OF ITS TARGET LOCATION. CONSEQUENTLY, THE WALLFLEX DUODENAL STENT WAS REMOVED FROM THE PATIENT WITH 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 FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760156 ↗
• MalfunctionMay 13, 2022Positioning Failure; Premature Activation; Positioning Failure; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 19, 2022 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED TO TREAT 7CM MALIGNANT STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE DELIVERY SYSTEM AND ANOTHER WALLFLEX DUODENAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. AFTER THE WALLFLEX WAS REMOVED, THE STENT ACCIDENTALLY DEPLOYED OUTSIDE THE PATIENT/SCOPE. 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 14400518 ↗
• MalfunctionFeb 16, 2022Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 25, 2022 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A MALIGNANT STRICTURE DUE TO GASTRIC OUTLET OBSTRUCTION (GOO) DURING A DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DID NOT DEPLOY. THE STAINLESS STEEL TUBE HANDLE WAS FOUND BENT. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS NOT COMPLETED AS ANOTHER STENT OF THE SAME SIZE WAS UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542579 ↗
• MalfunctionAug 12, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED TO TREAT A 2-3CM STRICTURE IN THE DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH 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 ABLE TO BE DEPLOYED IN THE CORRECT LOCATION CONFIRMED WITH FLUOROSCOPY AND ENDOSCOPIC VIEW; HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, THE STENT CAME OUT ALONG WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS CANCELLED AND RESCHEDULED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313332 ↗
• InjuryJul 12, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 21, 2021 THAT A WALLFLEX DUODENAL STENT WAS IMPLANTED TO TREAT A 4CM MALIGNANT GASTRIC OUTLET OBSTRUCTION IN THE DUODENUM/PYLORUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT'S ANATOMY WAS TORTUOUS. ON (B)(6) 2021, THE PATIENT EXPERIENCED DISCOMFORT AND AN ENDOSCOPY PROCEDURE WAS PERFORMED WHERE IT WAS NOTED THAT THE STENT MIGRATED. THE PHYSICIAN ATTEMPTED TO RE-POSITION THE STENT USING RAT TOOTH FORCEPS; HOWEVER, THE PHYSICIAN WAS UNSUCCESSFUL. A DIFFERENT SIZED WALLFLEX DUODENAL STENT WAS PLACED STENT-IN-STENT TO COMPLETE THE PROCEDURE. THE PATIENT WAS PRESCRIBED NPO (NOTHING BY MOUTH) FOR TWO DAYS TO ADDRESS THE DISCOMFORT. THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Discomfort

  MAUDE report 12150954 ↗
• MalfunctionMay 6, 2021Positioning Failure; Appropriate Device Problem Term/Code Not Available; Positioning Failure; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 14, 2021 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED TO TREAT AN 8-9 CM MALIGNANT STRICTURE IN THE PYLORUS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CANCELLED DUE TO DEVICE AVAILABILITY. 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 11783283 ↗
• InjuryMar 23, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX DUODENAL STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE SMALL BOWEL DURING A PROCEDURE PERFORMED IN (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. ON (B)(6) 2021, POST STENT PLACEMENT, IMAGING WAS PERFORMED AND IT WAS NOTED THAT THE LOOPS ON THE DISTAL END OF THE STENT HAD MIGRATED INTO THE SMALL BOWEL CAUSING A PERFORATION. THE PATIENT WAS SENT TO SURGERY TO SEAL THE PERFORATION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Bowel Perforation

  MAUDE report 11553640 ↗
• MalfunctionMar 18, 2021Premature Activation; Defective Device; Premature Activation; Defective Device

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2021-01144 AND # 3005099803-2021-01145 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 25, 2021 THAT TWO WALLFLEX DUODENAL STENTS WERE IMPLANTED TO TREAT A MALIGNANT PANCREATIC HEAD MASS CAUSING EXTRINSIC PRESSURE IN THE DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCPOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT HAD A METASTATIC PANCREAS CANCER AND GASTRIC OUTLET OBSTRUCTION. REPORTEDLY, THE PATIENT HAD TWO DUODENAL STENOSES; ONE AT D1/D2 JUNCTION AND THE OTHER AT D2/D3 JUNCTION. DURING THE PROCEDURE, A STIFF WALLSTENT GUIDEWIRE WAS PASSED, AND THE 22X120 MM UNCOVERED WALLFLEX DUODENAL STENT (THE SUBJECT OF MFR. REPORT# 3005099803-2021-01144) DEPLOYED PREMATURELY AND WAS PLACED MORE PROXIMAL. THE FULLY EXPANDED STENT SEEMED MUCH SHORTER THAN A 12 CM STENT VISUALIZED ENDOSCOPICALY AND FLUOROSCOPICALLY. THE STENT WAS MEASURED TO BE 6 CM. A SECOND WALLFLEX DUODENAL STENT WITH A STENT SIZE OF 22X 90 MM STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED. THE STENT DEPLOYED P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516240 ↗
• MalfunctionMar 10, 2021Positioning Failure; Use of Device Problem; Activation Failure; Positioning Failure; Use of Device Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2021 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED DURING A DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2021. IT WAS REPORTED THAT THE STENT DID NOT OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2021. IT WAS REPORTED THAT THE STENT WAS TO BE IMPLANTED TO TREAT A 65 MM STRICTURE IN THE ESOPHAGUS DUE TO STOMACH ULCER. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. REPORTEDLY, THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. NOTE: IT WAS REPORTED THAT THE WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS. HOWEVER, WALLFLEX DUODENAL STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM DIRECTIONS FOR USE (DFU) STATES THAT THE DEVICE IS USED FOR PALLIATIVE TREATMENT OF GASTRODUODENAL OBSTRUCTIONS PRODUCED BY MALIGNANT NEOPLASMS. THE STENT IS NOT INDICATED TO BE IMPLANTED IN THE ESOPHAGUS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE STENT FAILED T

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11455276 ↗