WallFlex™ Colonic M00565050Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 08714729456520), received between Mar 29, 2017 and Sep 24, 2026 — classified as 2 deaths, 31 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (17 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Premature Activation; Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884367 ↗
• MalfunctionJul 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876856 ↗
• InjuryMar 10, 2026Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS IMPLANTED INTO THE COLON TO TREAT A STRICTURE CAUSED BY CANCER DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUROUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING PROCEDURE, A ZEBRA GUIDEWIRE WAS INSERTED INTO THE NARROWED CAVITY AND PASSED TO THE DISTAL END ON THE SIDE OF THE LESION. THEN, A STENT PUSHER WAS INTRODUCED ALONG THE GUIDEWIRE. UNDER THE DIRECT VISION OF THE ENDOSCOPE, IT WAS CONFIRMED AND THEN SLOWLY RELEASED. THE BOTTOM YELLOW MARK OF STENT WAS NOT CLEARLY MARKED. IT WAS OBSERVED THAT THE STENT WAS NOT POSITIONED PROPERLY, WHICH CAUSED SOME OF THE LESIONS TO BE NOT FULLY COVERED. TO RESOLVE THE ISSUE, A NON-BOSTON SCIENTIFIC STENT WAS ADDED ON THE ANAL SIDE OF THE LESION. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559708 ↗
• InjuryJan 20, 2026Difficult or Delayed Positioning; Difficult to Advance; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC ENTERAL STENT WAS TO BE IMPLANTED IN THE INTESTINES TO TREAT INTESTINAL OBSTRUCTION DUE TO MALIGNANT TUMORS DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS (TIGHT) PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT WHEN THE STENT WAS DEPLOYED, IT FELL OFF PREMATURELY, THE DEPLOYMENT WAS NOT ACCURATE, AND THE THERAPEUTIC EFFECT COULD NOT BE ACHIEVED. IT WAS FURTHER REPORTED THAT THE ADVANCER WAS STUCK AND THE RELEASE WAS INACCURATE. THE STENT WAS THEN REMOVED USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24117334 ↗
• InjuryNov 27, 2025Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED IN THE COLON TO TREAT A COLONIC OBSTRUCTION DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TIGHT OR TORTUOUS PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT FAILED TO EXPAND INSIDE THE PATIENT. THE STENT WAS UNABLE TO BE RETRIEVED SAFELY. THEREFORE, THE PHYSICIAN LEFT THE STENT IN PLACE AS IT POSED LESS RISK TO THE PATIENT THAN TO REMOVE IT. THE PROCEDURE WAS THEN COMPLETED BY IMPLANTING ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23666188 ↗
• MalfunctionMay 13, 2025Failure to Advance; Activation, Positioning or Separation Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Activation, Positioning or Separation Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE SIGMOID COLON TO TREAT AN 5CM INTESTINAL OBSTRUCTION SECONDARY TO SIGMOID COLON CANCER DURING INTESTINAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2025. THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE TIP OF THE STENT DELIVERY SYSTEM BECAME KINKED. AS A RESULT, THE DEVICE COULD NOT CROSS THE STENOSIS, AND STENT DEPLOYMENT COULD NOT BE COMPLETED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011076 ↗
• MalfunctionApr 30, 2025Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED IN THE COLON TO TREAT A COLONIC STRICTURE DUE TO CANCER DURING METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING PROCEDURE, THE STENT FAILED TO OPEN WHILE TRYING TO OPEN THE STENT AT THE STRICTURE SITE. THE PHYSICIAN ATTEMPTED MULTIPLE TIMES TO DEPLOY THE STENT HOWEVER IT DID NOT OPEN. THE PROCEDURE WAS NOT COMPLETED AS IT WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939652 ↗
• InjurySep 9, 2024Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED IN THE COLON TO TREAT A 4CM MALIGNANT TUMOR DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHEN THE STENT WAS DEPLOYED, THE ANTERIOR PORTION OF THE STENT COULD NOT BE DEPLOYED. SUBSEQUENTLY, THE STENT'S DELIVERY SYSTEM WAS ADJUSTED, AND THE STENT WAS DEPLOYED CONTINUOUSLY; HOWEVER, THE STENT SUDDENLY SLIPPED AND WAS DEPLOYED INSIDE THE PATIENT. BOTH SNARES AND FORCEPS WERE USED MULTIPLE TIMES IN AN ATTEMPT TO REMOVE THE STENT, BUT IT WAS UNABLE TO BE REMOVED. ANOTHER WALLFLEX ENTERAL COLONIC 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 20170823 ↗
• InjuryJul 18, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE DESCENDING COLON TO TREAT AN ADENOMA CARCINOMA OF DESCENDING COLON DURING A COLONOSCOPY 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. HOWEVER, AFTER THE RUSH OF FLUID AND FECAL MATTER OUT OF THE STRICTURE THEY DID NOT SEE THE STENT PROTRUDING FROM THE STRICTURE. THE STENT WAS DEPLOYED TOO DEEP, AND IT WAS DEPLOYED ON A PARTIAL PART OF THE STRICTURE. THE STENT WAS ATTEMPTED TO BE REPOSITIONED, BUT THE STRICTURE WAS TOO TIGHT AS THE TUMOR WAS TOO BIG THAT A FOREIGN BODY RETRIEVER COULD NOT BE INSERTED. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER WALLFLEX COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772407 ↗
• MalfunctionJun 18, 2024Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A DUODENAL BULB STENOSIS DURING AN INTESTINAL STENT RETENTION PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED, AND IT WAS OBSERVED THAT THE MOUTH OF THE STENT WAS IN A SHAPE OF AN IRREGULAR RING. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED USING ANOTHER WALLFLEX COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559864 ↗
• MalfunctionJun 11, 2024Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED TO TREAT A 4CM MALIGNANT SPLENIC INTESTINAL STENOSIS DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT COULD NOT BE FULLY DEPLOYED. THE STENT WAS RETRACTED AND WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS NOT COMPLETED. 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 19512980 ↗
• MalfunctionFeb 26, 2024Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED TO TREAT A MALIGNANT INTESTINAL OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE LOCATION OF THE LESION BLOCKED THE INTESTINAL CAVITY AND IS HIGHLY EDEMATOUS. DURING THE PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED; HOWEVER, THE PATIENT'S PAIN WORSENED. CONSEQUENTLY, THE PROCEDURE WAS STOPPED, AND THE STENT WAS REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS NOT COMPLETED DUE TO THE SAME DEVICE NOT BEING AVAILABLE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. IN THE PHYSICIAN'S ASSESSMENT, THE PAIN WAS CAUSED BY THE INTESTINAL OBSTRUCTION AND THERE WAS NO RELATIONSHIP WITH THE WALLFLEX ENTERAL STENT. THE PAIN WAS RESOLVED BY GASTROINTESTINAL DECOMPRESSION AND CLEANSING ENEMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778326 ↗
• MalfunctionJan 29, 2024Entrapment of Device; Premature Activation; Difficult to Remove; Entrapment of Device; Premature Activation; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED TO TREAT AN INTESTINAL OBSTRUCTION IN THE INTESTINAL TRACT DURING A COLONIC STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE WAS ADVANCED; HOWEVER, IT GOT STUCK. THE NURSE ATTEMPTED TO REMOVE THE GUIDEWIRE BUT ENCOUNTERED DIFFICULTY IN DOING SO. THE GUIDEWIRE WAS EVENTUALLY REMOVED; HOWEVER, THE STENT PREMATURELY DEPLOYED OUTSIDE THE PATIENT. 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 18596383 ↗
• InjuryNov 6, 2023Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE INTESTINE TO TREAT AN INTESTINAL OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, THE STENT WAS UNABLE TO EXPAND. THE STENT WAS REMOVED WITH FORCEPS AND ANOTHER WALLFLEX ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. IN ADDITION, IT WAS NOTED THAT ACTION TAKEN BY THE PHYSICIAN TO RESOLVE THE EVENT ALSO INCLUDED OBSERVATION. 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 18079838 ↗
• InjuryOct 27, 2023Difficult or Delayed Positioning; Difficult to Remove; Material Deformation; Positioning Problem; Difficult or Delayed Positioning; Difficult to Remove; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED IN THE COLON TO TREAT A MALIGNANT STRICTURE DURING A SIGMOIDOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN DEPLOYING THE STENT. THE STENT WAS EVENTUALLY DEPLOYED BUT IT WAS DEPLOYED IN AN INCORRECT LOCATION. SUBSEQUENTLY, THE STENT WAS ATTEMPTED TO BE REMOVED WITH FORCEPS; HOWEVER, THE RETRIEVAL LOOP STRAIGHTENED OUT AND THE STENT COULD NO LONGER BE REMOVED. A LONGER WALLFLEX ENTERAL STENT WAS PLACED STENT-IN-STENT 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 18021164 ↗
• MalfunctionOct 3, 2023Break; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Break; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE SIGMOID COLON TO TREAT AN INTESTINAL OBSTRUCTION DUE TO INTESTINAL CANCER DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED DESPITE COMPLETELY PULLING THE HANDLE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE STENT WIRES WERE BROKEN. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS RESCHEDULED FOR A RADICAL RESECTION OF THE COLON LATER THAT DAY TO TREAT THE PATIENT'S UNDERLYING CONDITION OF CANCER. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859735 ↗
• MalfunctionJun 9, 2023Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT# 3005099803-2023-03080, 3005099803-2023-03081, 3005099803-2023-03082, AND 3005099803-2023-03083 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 24, 2023, THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE SIGMOID COLON TO TREAT A 6 CM MALIGNANT COLONIC OBSTRUCTION DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE FIRST WALLFLEX COLONIC STENT (THE SUBJECT OF THIS REPORT) DID NOT DEPLOY, THE HANDLE BROKE, AND THE STAINLESS-STEEL SHAFT WAS KINKED. A SECOND WALLFLEX COLONIC STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-03081) WAS USED, BUT SIMILAR ISSUE WAS ENCOUNTERED. THE STENT DID NOT DEPLOY, THE HANDLE BROKE, AND THE STAINLESS-STEEL SHAFT KINKED. A THIRD WALLFLEX COLONIC STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-03082) WAS USED, BUT THE STENT DID NOT DEPLOY, AND THE STAINLESS-STEEL SHAFT WAS KINKED. A FOURTH WALLFLEX COLONIC STENT (THE SUBJECT OF MFR. REPORT # 3005099803-20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098577 ↗
• MalfunctionJun 9, 2023Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT# 3005099803-2023-03080, 3005099803-2023-03081, 3005099803-2023-03082, AND 3005099803-2023-03083 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 24, 2023, THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE SIGMOID COLON TO TREAT A 6 CM MALIGNANT COLONIC OBSTRUCTION DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE FIRST WALLFLEX COLONIC STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-03080) DID NOT DEPLOY, THE HANDLE BROKE, AND THE STAINLESS-STEEL SHAFT WAS KINKED. A SECOND WALLFLEX COLONIC STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-03081) WAS USED, BUT SIMILAR ISSUE WAS ENCOUNTERED. THE STENT DID NOT DEPLOY, THE HANDLE BROKE, AND THE STAINLESS-STEEL SHAFT KINKED. A THIRD WALLFLEX COLONIC STENT (THE SUBJECT OF THIS REPORT) WAS USED, BUT THE STENT DID NOT DEPLOY, AND THE STAINLESS-STEEL SHAFT WAS KINKED. A FOURTH WALLFLEX COLONIC STENT (THE SUBJECT OF MFR. REPORT # 3005099803-20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098471 ↗
• InjuryJun 6, 2023Premature Activation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Premature Activation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 18, 2023, THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT A 3 CM MALIGNANT INTESTINAL OBSTRUCTION DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS DEPLOYING THE STENT, THE INNER SHEATH DETACHED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL COLONIC STENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. IT WAS REPORTED THAT THE INNER SHEATH WAS NOT DETACHED, AND THE STENT WAS NOT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT; INSTEAD, THE STENT HAD PREMATURELY DEPLOYED INSIDE THE PATIENT AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074931 ↗
• MalfunctionApr 20, 2023Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE COLO-HEPATIC REGION TO TREAT A 5CM MALIGNANT INTESTINAL OBSTRUCTION DUE TO ADENOCARCINOMA DURING AN INTESTINAL STENT IMPLANTATION PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED SMOOTHLY INSIDE THE PATIENT. THE OUTER SHEATH WAS KINKED, AND THE STENT WAS PARTIALLY DEPLOYED WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL COLONIC STENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775279 ↗
• MalfunctionNov 8, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED TO TREAT A 70MM MALIGNANT COLONIC OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TIGHT. DURING THE PROCEDURE, THE WALLFLEX ENTERAL COLONIC STENT WAS UNABLE TO DEPLOY. THE WALLFLEX ENTERAL COLONIC STENT WAS FULLY COVERED BY THE OUTER SHEATH ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO DEVICE AVAILABILITY. 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 15755751 ↗
• InjurySep 15, 2022Break; Positioning Failure; Use of Device Problem; Break; Positioning Failure; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 18, 2022 THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE SIGMOID COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, A SCOPE WAS INITIALLY PLACED THEN THE GUIDEWIRE WAS PUT THROUGH AND WAS ADVANCED TO THE OBSTRUCTION. THE WALLFLEX ENTERAL COLONIC STENT WAS PUT OVER THE WIRE AND PUSHED THROUGH THE OBSTRUCTION ALONG WITH THE SCOPE. THE PHYSICIAN THEN REMOVED THE SCOPE AND ATTEMPTED TO DEPLOY THE STENT WITH 100% FLUOROSCOPY. DURING STENT DEPLOYMENT, RESISTANCE WAS MET AND A "POP" WAS FELT AT THE HANDLE AND THE HANDLE WAS NOTED TO BE BROKEN. SUBSEQUENTLY, THE WALLFLEX ENTERAL COLONIC STENT WAS UNABLE TO BE DEPLOYED AND WAS REMOVED FROM THE PATIENT. POST PROCEDURE, THE PATIENT ABDOMEN LOOKED DISTENDED. COLONOSCOPY WAS PERFORMED AND PERFORATION WAS NOTED ABOVE THE STRICTURE. SURGERY WAS DONE ON THE SAME DAY TO CLOSE THE PERFORATION. THE PATIENT WAS FULLY RECOVERED AT THE END OF THE PROCEDURE. NOTE: IN THE PHYSICIAN'S ASSESSMENT THERE WAS NO RELATIONSHIP BETWEEN THE STENT FAILURE TO DEPLOY, HANDLE BREAK AND THE

  Patient problems: Perforation

  MAUDE report 15433037 ↗
• MalfunctionJun 9, 2022Difficult or Delayed Positioning; Premature Activation; Difficult or Delayed Positioning; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED IN THE COLON TO TREAT A 5CM INTESTINAL OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. DURING ATTEMPTED DEPLOYMENT, THE DELIVERY SHAFT BECAME STUCK AND THE STENT WAS UNABLE TO BE DEPLOYED. UPON WITHDRAWAL OF THE DELIVERY SYSTEM, THE STENT DEPLOYED PREMATURELY IN AN INCORRECT LOCATION. THE STENT REMAINS IMPLANTED AND ANOTHER WALLFLEX COLONIC 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 14642494 ↗
• MalfunctionMay 27, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 05, 2022 THAT A WALLFLEX COLONIC STENT WAS TO BE USED IN THE COLON TO TREAT AN INTESTINAL OBSTRUCTION DURING STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING UNPACKING AND OUTSIDE PATIENT, THE PHYSICIAN NOTICED THAT THE INNER STERILE PACKAGING WAS DAMAGED. THE DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX COLONIC 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14526714 ↗
• MalfunctionMar 15, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 18, 2022 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE SIGMA-COLON TO TREAT A STENOSIS DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, RESISTANCE WAS FELT DURING ATTEMPTED STENT DEPLOYMENT AND THE HANDLE OF THE STENT DELIVERY SYSTEM BROKE. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776506 ↗