WallFlex™ Colonic M00565040Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729456513), received between Jun 29, 2017 and Feb 11, 2026 — classified as 1 death, 10 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED TO TREAT AN APPROXIMATELY 2CM MALIGNANT COLONIC STRICTURE DURING A COLONOSCOPY PERFORMED ON (B)(6) 2026. THE PATIENT'S ANATOMY WAS REPORTED TO BE TIGHT DUE TO THE STRICTURE BUT WAS NOT CONSIDERED TORTUOUS. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DEPLOY THE STENT. DEPLOYMENT HAD ONLY REACHED APPROXIMATELY THE MID-POINT, AND THE RADIOPAQUE (RO) MARKER HAD NOT YET REACHED THE POINT OF NO RETURN WHEN THE PHYSICIAN OBSERVED THAT THE STENT HAD ALREADY BEEN FULLY DEPLOYED TOWARD THE SPLENIC FLEXURE. THE STENT REMAINS IMPLANTED AND ANOTHER WALLFLEX ENTERAL COLONIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS NOTED TO HAVE FULLY RECOVERED FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317099 ↗
• InjuryJan 6, 2026Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT ANATOMY WAS TORTUOUS (TIGHT) PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DID NOT FULLY EXPAND AND SHIFTED FROM THE TARGETED POSITION. THEREFORE, FORCEPS WAS USED TO REMOVED THE UNEXPANDED STENT AND 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 23982123 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE IN THE COLON DURING A COLONOSCOPY WITH COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DELIVERY SYSTEM BROKE IN HALF. THE PROCEDURE WAS CANCELLED. THERE ARE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369279 ↗
• MalfunctionApr 23, 2025Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; 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 IMPLANTED IN THE COLON TO TREAT A 3 CM TUMOR DUE TO COLONIC CANCER DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING PROCEDURE, THE SUPPORTING FORCE OF THE INNER SHEATH WAS NOT ENOUGH, RESULTING FOR THE STENT BEING NOT ABLE TO DEPLOY. WHEN THE STENT WAS REMOVED FROM THE PATIENT IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT AND THE CONDITION OF THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890810 ↗
• MalfunctionSep 18, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED IN THE COLON TO TREAT A 2CM MALIGNANT OBSTRUCTION DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENTS ANATOMY WAS TORTUOUS AND NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT DEPLOYED BEYOND THE INTENDED LOCATION. THE PHYSICIAN USED A DIFFERENT SIZE STENT TO COMPLETE THE PROCEDURE. THE STENT REMAINS IMPLANTED, AND THE PHYSICIAN IS COMFORTABLE LEAVING THE STENT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246309 ↗
• MalfunctionMar 18, 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 MALIGNANT 4 CM NEOPLASTIC COLON STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2024. DURING THE PROCEDURE, THE STENT CAME OUT TOO QUICKLY WHEN THE DELIVERY CATHETER WAS RETRACTED. FORTUNATELY, THE STENT WAS DEPLOYED IN THE CORRECT LOCATION, AND NO INTERVENTION WAS REQUIRED. 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 18921855 ↗
• MalfunctionNov 17, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED, IT WAS NOTED THAT THE STENT WAS HANGING OUT OF THE RECTUM INSTEAD OF BEING IN THE BOWEL. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165653 ↗
• DeathOct 12, 2023Adverse Event Without Identified Device or Use Problem; 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 TRANSVERSE COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PATIENT HAD PERFORATION. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGERY TO ADDRESS THE PERFORATION; HOWEVER, ON AN UNKNOWN DATE, POST SURGERY, THE PATIENT PASSED AWAY. THE PATIENT'S CAUSE OF DEATH IS UNKNOWN; HOWEVER, IT WAS CONFIRMED THAT THE PATIENT HAD MANY COMORBIDITIES AND HEALTH PROBLEMS PRIOR TO STENT PLACEMENT. IN ADDITION, THE PATIENT HAD AN ENLARGED COLON CONSIDERABLY INCREASING THE RISK OF PERFORATION. FURTHERMORE, THERE WERE NO PROBLEMS REPORTED ON THE WALLFLEX ENTERAL STENT, HOWEVER, THE PATIENT'S ANATOMY WAS VERY DIFFICULT.

  Patient problems: Perforation

  MAUDE report 17923304 ↗
• 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 IN FORMATION. 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 THIS REPORT) 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 # 3005099803-2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098964 ↗
• 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 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 THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098473 ↗
• InjuryJan 30, 2023Premature Activation; Difficult to Remove; Premature Activation; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 9, 2023, THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED IN THE PROXIMAL PORTION OF THE COLON TO TREAT A MALIGNANT TUMOR DUE TO COLONIC CANCER DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT PREMATURELY DEPLOYED. THE PATIENT UNDERWENT AN ADDITIONAL COLONOSCOPY IN AN ATTEMPT TO REMOVE THE STENT, HOWEVER, IT WAS NOT POSSIBLE TO RETRIEVE THE STENT AS IT HAS ALREADY EXPANDED, AND RETRIEVAL MAY CAUSE POTENTIAL DAMAGE TO THE PATIENT'S MUCOSA AND VASCULARIZED TUMOR. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE ADDITIONAL COLONOSCOPY PROCEDURE WAS PERFORMED THE NEXT DAY, POST STENT DEPLOYMENT. DURING COLONOSCOPY PROCEDURE, IT WAS OBSERVED THAT THE WALLFLEX COLONIC STENT HAD ACCOMMODATED PROPERLY ONTO THE COLONIC MUCOSA AFTER IT EXPANDED. THE STENT WAS NOT REMOVED, AND THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACE. THE ADDITIONAL COLONOSCOPY WAS A SCHEDULED PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16268534 ↗
• MalfunctionDec 15, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED TO TREAT A 2-3CM MALIGNANT STRICTURE DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE STENT WAS POSITIONED CORRECTLY FOR DEPLOYMENT; HOWEVER, IT WAS NOT COMPLETELY RELEASED AS THE DELIVERY SYSTEM BECAME STUCK. THE PHYSICIAN MOVED THE DELIVERY SYSTEM SEVERAL TIMES AND IT WAS EVENTUALLY REMOVED. THE WALLFLEX ENTERAL COLONIC STENT REMAINED IMPLANTED 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 15987189 ↗
• MalfunctionJul 22, 2021Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 30, 2021 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO TREAT A RECTAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED, THE STENT CAME OUT ALONG WITH THE DELIVERY SYSTEM. REPORTEDLY, THE WIRE OF THE PROXIMAL PART OF THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH 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 12214485 ↗
• InjuryJun 9, 2021Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED IN THE RECTUM TO TREAT A 1.5CM STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, THE PROXIMAL FLANGE OF THE STENT DID NOT EXPAND. THE STENT REMAINS IMPLANTED AND A 90MM WALLFLEX COLONIC STENT WAS PLACED STENT-IN-STENT TO OPEN THE PROXIMAL FLANGE AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN WAS COMFORTABLE LEAVING BOTH STENTS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971271 ↗
• InjuryApr 20, 2021Positioning Problem; Activation Failure; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 26, 2021 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PROXIMAL FLARED END OF THE STENT DID NOT FULLY EXPAND. AFTER COMPLETE DEPLOYMENT, THE STENT MOVED DISTALLY WITH THE UNEXPANDED PROXIMAL END JUST ABOVE THE TUMOR. THE STENT WAS REMOVED FROM THE PATIENT USING RAT-TOOTH FORCEPS AND ANOTHER WALLFLEX COLONIC STENT WAS IMPLANTED 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 11695324 ↗
• InjuryFeb 11, 2021Difficult to Advance; Positioning Problem; Difficult to Advance; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED TO TREAT A 3CM MALIGNANT STRICTURE IN THE SIGMOID COLON DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE GUIDEWIRE HAD DIFFICULTY EXITING THE END OF THE DELIVERY SYSTEM INSIDE THE PATIENT; HOWEVER, IT WAS EVENTUALLY ABLE TO EXIT WHEN THE PHYSICIAN PULLED THE GUIDEWIRE. REPORTEDLY, RESISTANCE WAS FELT WHEN THE DELIVERY SYSTEM WAS ADVANCED THROUGH THE SCOPE. THE STENT WAS FULLY DEPLOYED IN THE INCORRECT LOCATION AND THE PHYSICIAN SUCCESSFULLY ADJUSTED THE POSITION OF THE STENT USING RAT TOOTH FORCEPS. REPORTEDLY, THE STENT REMAINS IMPLANTED AND THE PROCEDURE WAS COMPLETED. 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 11313100 ↗
• InjuryJan 12, 2021Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2020 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO TREAT A 3 CM MALIGNANT MASS OBSTRUCTION IN THE COLON DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT PREMATURELY DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT USING A SNARE. REPORTEDLY, THE PROCEDURE WAS NOT COMPLETED BECAUSE THE SAME DEVICE WAS UNAVAILABLE. ON (B)(4) 2020, A SECOND STENT PLACEMENT PROCEDURE WAS PERFORMED AND ANOTHER WALLFLEX COLONIC STENT WAS SUCCESSFULLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE DECOMPRESSED/GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11156230 ↗
• InjuryDec 10, 2020Break; Difficult to Remove; Material Deformation; Break; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 20, 2020 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED TO TREAT A TUMOR IN THE COLON DURING A COLONIC STENTING PROCEDURE PERFORMED ON (B)(6) 2020. 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 SUCCESSFULLY DEPLOYED CONFIRMED BY THE X-RAY IMAGE; HOWEVER, THERE WAS A LOT OF RESISTANCE TO REMOVE THE DELIVERY SYSTEM. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED; HOWEVER, IT WAS NOTED THAT THE STENT WAS BROKEN AND DEFORMED. THE STENT WAS REMOVED USING A RAT TOOTH FORCEPS AND ANOTHER WALLFLEX COLONIC STENT WAS IMPLANTED 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. NOTE: A PHOTO OF THE COMPLAINT DEVICE POST PROCEDURE WAS PROVIDED BY THE COMPLAINANT AND IT SHOWED A BROKEN AND DEFORMED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10983887 ↗
• InjuryNov 20, 2020Premature Activation; Difficult to Remove; Material Deformation; Premature Activation; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO TREAT COLON CANCER DURING A COLONOSCOPY 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 PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT PREMATURELY DEPLOYED INTO THE STRICTURE. THE STENT WAS ATTEMPTED TO BE REPOSITIONED WITH RAT-TOOTH FORCEPS; HOWEVER, THE STENT FULLY UNRAVELED LOSING ITS SHAPE. REPORTEDLY, THE STENT WAS THEN REMOVED FROM THE PATIENT WHERE THERE WAS SLIGHT RESISTANCE PULLING THE STENT THROUGH THE STRICTURE. 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 FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10875301 ↗
• InjuryApr 12, 2019Difficult or Delayed Positioning; Premature Activation; Difficult or Delayed Positioning; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED IN THE SIGMOID COLON TO TREAT A 6-7 CM MASS DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS DIFFICULT TO UNSHEATHE THE STENT. THE STENT SUDDENLY DEPLOYED THROUGH THE STRICTURE AND MOVED TO THE PROXIMAL PART OF THE COLON. A LONGER WALLFLEX COLONIC STENT WAS PLACED STENT-IN-STENT WITHIN THE INITIAL STENT 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 GOOD WITH PASSING GAS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509485 ↗
• MalfunctionJan 10, 2019Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX COLONIC STENT WAS TO BE USED TO TREAT A 4CM MALIGNANT STRICTURE IN THE COLON DUE TO COLORECTAL CANCER DURING A LOWER GASTROINTESTINAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT PREMATURELY DEPLOYED AND WAS FREE FLOATING IN THE LUMEN. THE STENT WAS REMOVED WITH FORCEPS AND ANOTHER WALLFLEX COLONIC STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8237608 ↗
• MalfunctionJan 10, 2019Difficult to Remove; Difficult to Remove

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2019-00053 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 16, 2018 THAT TWO WALLFLEX COLONIC STENTS WERE USED DURING A COLONIC STENTING PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND THE WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST WALLFLEX COLONIC STENT (THE SUBJECT OF THIS REPORT) WAS "NOT ATTACHED TO THE LESION", AND THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE. REPORTEDLY, THE STENT CAME OUT ALONG WITH THE DELIVERY SYSTEM DURING CATHETER REMOVAL. A SECOND WALLFLEX COLONIC STENT ( THE SUBJECT OF MFR. REPORT # 3005099803-2019-00053) WAS USED BUT THE SAME THING OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE SHOWED A FULLY DEPLOYED STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8237287 ↗
• InjuryJun 29, 2017Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED TO TREAT AN INTESTINAL OBSTRUCTION IN THE COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING DEPLOYMENT, THE STENT WAS NOT IN THE PROPER LOCATION. THE PHYSICIAN TRIED TO RECONSTRAIN THE STENT BUT THE STENT COULD NOT BE RECONSTRAINED. THE PHYSICIAN THEN DECIDED TO RELEASE THE STENT AND ANOTHER WALLFLEX COLONIC 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6676720 ↗