WallFlex™ Colonic M00565060Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729456537), received between Feb 17, 2017 and Jan 19, 2026 — classified as 2 deaths, 16 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (9 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE SIGMOID COLON TO TREAT AN INTESTINAL OBSTRUCTION DUE TO SIGMOID COLON CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CONNECTION AT THE FRONT SECTION OF THE WALLFLEX STENT HAD BECOME MISALIGNED, AND IT WAS NOTED THAT THE STENT HAD BURRS ON THE SURFACE. THE STENT WAS REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112037 ↗
• InjuryJan 8, 2026Activation, Positioning or Separation Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL STENT WAS TO BE IMPLANTED IN THE SIGMOID COLON TO TREAT SIGMOID STENOSIS DURING AN ENDOSCOPIC INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY AND ADVANCE. IT WAS NOTED THAT THE STENT FAILED TO EXPAND; HENCE, THE STENT WAS REMOVED USING SNARES. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 21, 2026: IT WAS LATER CONFIRMED THAT A PART OF THE STENT WAS ATTACHED TO THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003826 ↗
• MalfunctionJan 7, 2026Positioning Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE SIGMOID COLON TO TREAT A MALIGNANT STENOSIS DURING AN ENDOSCOPIC INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS SEVERELY TORTUOUS. DURING THE PROCEDURE, THE STENT DID NOT EXPAND PROPERLY AND WAS REMOVED USING A SNARE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. ***ADDITIONAL INFORMATION RECEIVED ON JANUARY 14, 2026*** IT WAS REPORTED THAT THE STENT DID NOT DEPLOY AND WAS REMOVED WITHOUT USING A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996636 ↗
• MalfunctionOct 20, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; 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 9CM MALIGNANT COLONIC TUMOR DURING AN ENDOSCOPIC COLON STENTING PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE STENT WAS MANAGED TO BE FULLY DEPLOYED. HOWEVER, IT WAS NOTICED THAT THERE WERE RUPTURED ZONES IN THE STENT, AND SINCE THE STENT HAD ALREADY BEEN DEPLOYED, IT COULD NO LONGER BE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH THIS STENT THE PATIENT WAS LEFT WITH THE DAMAGED STENT INSIDE. FUTURE OBSERVATIONS ARE REQUIRED SINCE IT IS POSSIBLE THAT THE PATIENT MIGHT HAVE A PERFORATION OR BLEEDING DUE TO THE STENT RUPTURE ZONES. THE PATIENT'S CONDITION WAS STABLE AT THE END OF THE PROCEDURE, AND THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 21, 2025: IT WAS LATER CONFIRMED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344150 ↗
• MalfunctionJul 21, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT COLONIC STRICTURE DURING A COLONIC STENTING PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT OVER THE GUIDEWIRE; HOWEVER, UNDER FLUOROSCOPIC GUIDANCE, IT WAS OBSERVED THAT THE STENT WAS NOT FULLY EXPANDING. APPROXIMATELY 80% OF THE STENT HAD BEEN DEPLOYED WHEN THE PROBLEM WAS IDENTIFIED. THE STENT WAS SUBSEQUENTLY REMOVED AND INSPECTED EXTERNALLY, WHERE IT WAS FOUND TO PARTIALLY OPEN BUT NOT AS EXPECTED. AS A RESULT, THE PROCEDURE WAS RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561673 ↗
• InjuryJul 18, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED TO TREAT A MALIGNANT COLONIC OBSTRUCTION DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE WALLFLEX COLONIC STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, WHEN THE NURSE RE-SHEATHED THE DELIVERY SYSTEM, THE OUTER TUBE GOT STUCK IN THE WORKING CHANNEL OF THE SCOPE AND THE CLEAR OUTER SHEATH BROKE OFF. THE DETACHED PART WAS THEN PUSHED OUT INTO THE COLON AND WAS RETRIEVED USING RAT TOOTH FORCEPS, 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 22546937 ↗
• MalfunctionMay 22, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT A COLON CANCER DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS KINKED, AND THE STENT WAS NOT USED IN THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377790 ↗
• InjuryJun 30, 2023Mechanical Problem; Difficult to Remove; Mechanical Problem; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 14, 2023 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO TREAT A 5CM MALIGNANT STENOSIS IN THE COLON DURING A COLON STENT DEPLOYMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED; HOWEVER, DUE TO INTESTINAL PERISTALSIS AND THE POSITIONING OF THE STENT, IT WAS ATTEMPTED TO BE RECAPTURED. DURING THE ATTEMPTED RECAPTURE, THE DELIVERY SYSTEM GOT STUCK, AND THE STENT WAS UNABLE TO BE FULLY RECAPTURED. THE PHYSICIAN THEN DECIDED TO REMOVE THE STENT; HOWEVER, THE TIP OF THE DEVICE WAS STUCK IN THE INTESTINAL WALL. A FOREIGN BODY FORCEP WAS USED TO REMOVE THE STENT, AND ANOTHER WALLFLEX COLONIC 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237859 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 06, 2023 THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED IN THE COLON TO TREAT A LESS THAN 8CM MALIGNANT STRICTURE DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS. A DAY POST STENT PLACEMENT, IT WAS OBSERVED THAT THE PATIENT'S WHITE BLOOD CELL COUNT WENT UP. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS DONE AND PERFORATION WAS CONFIRMED. SUBSEQUENTLY, SURGERY WAS PERFORMED TO TREAT THE PERFORATION AND REMOVE THE WALLFLEX COLONIC STENT. THE PATIENT IS GOOD FOLLOWING THE SURGERY.

  Patient problems: Bowel Perforation

  MAUDE report 17197829 ↗
• InjuryJan 13, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 27, 2022 THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE END POINT BETWEEN THE OLIVE TIP AND THE OUTER CLEAR SHEATH GOT KINKED AND THE PATIENT'S COLON HAD PERFORATED. IN THE PHYSICIAN'S ASSESSMENT, THE KINK ON THE DELIVERY SYSTEM WAS RELATED TO THE PERFORATION. CONSEQUENTLY, THE PATIENT UNDERWENT SURGERY TO ADDRESS THE PERFORATION. THE STENT WAS FULLY COVERED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THE PATIENT'S PERFORATION.

  Patient problems: Bowel Perforation

  MAUDE report 16161274 ↗
• MalfunctionDec 20, 2022Entrapment of Device; Positioning Problem; Entrapment of Device; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 01, 2022 THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN HAD SEEN AND CONFIRMED STENT DEPLOYMENT THROUGH FLOUROSCOPY EVEN THOUGH TWO COLONIC STENTS WERE IN SITU FROM PREVIOUS PROCEDURES, AND VISIBILITY THROUGH THE SCOPE WAS DIFFICULT. POST STENT DEPLOYMENT, WHEN THE SCOPE WAS BROUGHT FOR REPROCESSING CLEANING PROCESS, IT WAS NOTED THAT THE SCOPE WAS BLOCKED, AND THE WALLFLEX ENTERAL COLONIC STENT WAS FOUND DEPLOYED INSIDE THE SCOPE. IT IS UNKNOWN HOW WAS THE STENT REMOVED FROM THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 22, 2022: NO ADDITIONAL STENT WAS PLACED, AND THE PROCEDURE WAS NOT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019203 ↗
• MalfunctionNov 1, 2022Premature Activation; Use of Device Problem; Activation, Positioning or Separation Problem; Premature Activation; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE SPLEEN TO TREAT A SPLENOMEGALY DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2022. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE WALLFLEX COLONIC STENT COULD NOT BE DEPLOYED. THE WALLFLEX COLONIC STENT FULLY DEPLOYED WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX COLONIC STENT. 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. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6)2022*** IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED WHEN REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710511 ↗
• InjuryOct 12, 2022Positioning 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 ON (B)(6), 2022, THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE DIGESTIVE TRACT TO TREAT A MALIGNANT STRICTURE AND GASTROINTESTINAL BLEEDING DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY. WHEN THE DELIVERY SYSTEM WAS REMOVED, THE INNER SHEATH GOT DETACHED AND WAS REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL 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. NOTE: IT WAS REPORTED THAT THE WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED TO TREAT A GASTROINTESTINAL BLEEDING. PER THE WALLFLEX COLONIC STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM DIRECTIONS FOR USE (DFU), "THE DEVICE IS INDICATED FOR THE PALLIATIVE TREATMENT OF COLONIC STRICTURES PRODUCED BY MALIGNANT NEOPLASMS AND TO RELIEVE LARGE BOWEL OBSTRUCTION PRIOR TO COLECTOMY IN PATIENTS WITH MALIGNANT STRICTURES". THE STENT IS NOT INDICATED FOR THE TREATMENT OF GASTROI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587478 ↗
• MalfunctionSep 12, 2022Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT INTESTINAL STENOSIS IN THE LARGE INTESTINE DURING A DIRECT INTESTINAL IMPLANT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE GUIDEWIRE WAS DIFFICULT TO ADVANCE OVER THE WALLFLEX COLONIC STENT DELIVERY SYSTEM. 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE INNER SHEATH WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407399 ↗
• InjuryFeb 8, 2022Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT CANCER DURING A COLONIC STENTING PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE STENT FAILED TO OPEN. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX COLONIC STENT. A NON-SERIOUS INJURY WAS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Insufficient Information

  MAUDE report 13482580 ↗
• MalfunctionDec 13, 2021Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED TO TREAT A 9CM MALIGNANT INTESTINAL OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN ADVANCING THE DELIVERY SYSTEM THROUGH THE LESION AND THE STENT PREMATURELY DEPLOYED IN THE DISTAL END OF THE STENOSIS. THE STENT REMAINS IMPLANTED 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 AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12985144 ↗
• DeathDec 1, 2021Adverse 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 DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-06238 AND 3005099803-2021-06239 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 12, 2021 THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED TO TREAT AN APPROXIMATELY 3CM MALIGNANT RECTO-SIGMOID STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE STENT PLACEMENT PROCEDURE, A 9CM WALLFLEX ENTERAL COLONIC STENT (THE SUBJECT OF MFR. # 3005099803-2021-06238) WAS DEPLOYED IN THE INCORRECT POSITION SO A 12CM WALLFLEX ENTERAL COLONIC STENT (THE SUBJECT OF THIS REPORT) WAS ALSO PLACED TO FULLY BRIDGE THE STRICTURE. A WEEK AFTER THE STENT PLACEMENT PROCEDURE, THE PATIENT UNDERWENT CHEMOTHERAPY; HOWEVER, AFTER A FEW DAYS, SYMPTOMS OF PERFORATION WERE NOTED. IT WAS CONFIRMED THAT THE PATIENT'S BOWEL HAD PERFORATED AT THE IMPLANT SITE. THE PATIENT WAS TREATED WITH CRITICAL CARE FOR THE PERFORATION BUT THE PATIENT PASSED AWAY. IN THE PHYSICIAN'S ASSESSMENT, THE RELATIONSHIP BETWEEN THE STENTS AND THE PERFORATION/DEATH IS UNKNOWN.

  Patient problems: Bowel Perforation

  MAUDE report 12913199 ↗
• InjuryOct 28, 2021Premature Activation; Device Misassembled During Manufacturing /Shipping; Premature Activation; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT SHORT INTRINSIC COLONIC STRICTURE IN THE DISTAL SIGMOID COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, UPON DEPLOYING THE STENT, THE STENT PREMATURELY DEPLOYED AND WAS PLACED BEYOND THE STRICTURE. ADDITIONALLY, IT WAS NOTED THAT THE DELIVERY SYSTEM DID NOT HAVE A WHITE MARKER TO INDICATE THE POINT OF NO RETURN. A COLECTOMY SURGERY WAS PERFORMED TO RESECT PART OF THE PATIENT'S COLON WHERE THE STENT WAS DEPLOYED AND TO REMOVE THE STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712870 ↗
• MalfunctionNov 9, 2020Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT TUMOR IN THE DESCENDING COLON DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. REPORTEDLY, THE POSITION OF THE STRICTURE WAS VERY DIFFICULT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN RETRACTED THE SCOPE FOR VISUALIZATION, THE STENT PREMATURELY DEPLOYED IN THE SCOPE. THE STENT WAS REMOVED TOGETHER WITH THE SCOPE 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10812856 ↗
• InjuryMar 9, 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 COLONIC STENT WAS TO BE USED IN THE SIGMOID COLON TO TREAT A STENOSIS CAUSED BY PERITONEAL DISSEMINATION OF AN OVARIAN CANCER DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INTESTINAL WALL WAS PERFORATED WHEN THE STENT WAS DELIVERED AFTER GUIDEWIRE INSERTION. ACCORDING TO THE PHYSICIAN, THE CAUSE OF PERFORATION WAS UNKNOWN AND CANNOT BE IDENTIFIED. SURGERY WAS PERFORMED TO ADDRESS THE PERFORATION AND THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Code Available; Perforation

  MAUDE report 9808558 ↗
• InjuryAug 16, 2019Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 25, 2019 THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6)2019. ACCORDING TO THE COMPLAINANT, THE STENT "DID NOT STRETCH INSIDE THE BODY". THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. "DID NOT STRETCH INSIDE THE BODY" HAS BEEN INTERPRETED AS THE STENT FAILED TO EXPAND. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8900743 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 26, 2019 THAT A WALLFLEX COLONIC STENT HAS BEEN IMPLANTED IN THE COLON TO TREAT AN OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE STENT WAS PLACED FOR DECOMPRESSION BEFORE A SCHEDULED RESECTION AND THE PROCEDURE WENT WELL. ACCORDING TO THE COMPLAINANT, ON AN UNKNOWN DATE, THE PATIENT PRESENTED BACK TO THE HOSPITAL WITH A PERFORATED DIVERTICULITIS. THERE WAS NO REPORTED ISSUE WITH THE STENT AND IT IS UNKNOWN WHETHER THERE IS A RELATIONSHIP BETWEEN THE STENT AND THE PERFORATED DIVERTICULITIS. A SURGERY WAS PERFORMED BUT IT IS UNKNOWN WHEN THE SURGERY OCCURRED OR WHAT IT ENTAILED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available; Perforation

  MAUDE report 8808091 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 25, 2019 THAT A WALLFLEX COLONIC STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE OBSTRUCTING THE COLON DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE PATIENT'S TISSUE WAS FRIABLE AND THE PATIENT HAD UNDERGONE CHEMOTHERAPY OR RADIATION THERAPY. ACCORDING TO THE COMPLAINANT, DURING STENT PLACEMENT, THE STENT "GOT THROUGH FROM THE LATERAL WALL OF THE INTESTINES". THE PHYSICIAN FELT THAT THE INTESTINAL WALL WAS PERFORATED AND THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. ANOTHER WALLFLEX COLONIC STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE.THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. FLUOROSCOPY WAS PERFORMED AND CONFIRMED THE PERFORATION. REPORTEDLY, THE PHYSICIAN WAS UNCERTAIN WHAT CAUSED THE PERFORATION. THE PATIENT UNDERWENT INTESTINAL COLOSTOMY TO TREAT THE PERFORATION.

  Patient problems: Bowel Perforation; No Code Available

  MAUDE report 8805106 ↗
• DeathFeb 4, 2019Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2019-00353 AND 3005099803-2019-00380 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 10, 2019 THAT TWO WALLFLEX COLONIC STENTS WERE IMPLANTED TO TREAT A 6CM STENOSIS IN THE SIGMOID AND DESCENDING COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE FIRST 12CM WALLFLEX COLONIC STENT (THE SUBJECT OF THIS REPORT) WAS ADVANCED THROUGH THE ENDOSCOPE AND WAS DEPLOYED; HOWEVER, THE STENT "JUMPED" AND WAS PLACED NOT ON THE STENOSIS. A SECOND 9CM WALLFLEX COLONIC STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2019-00380) WAS IMPLANTED IN A STENT-IN-STENT PLACEMENT. REPORTEDLY, ON (B)(6) 2018, POST STENT PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED AN ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND CONFIRMED INTESTINAL PERFORATION. REPORTEDLY, THE PERFORATION SITE WAS ON THE DESCENDING COLON WHERE THE DISTAL END OF THE 9CM WALLFLEX COLONIC STENT WAS IN PLACED; HOWEVER, THE RELATIONSHIP BETWEEN THE STENT AND PERFORATION WAS UNKNOWN. ANTIBIOTIC WERE ADMINISTERED TO

  Patient problems: Abdominal Pain; Bowel Perforation; Death; Peritonitis

  MAUDE report 8302803 ↗
• MalfunctionAug 29, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX COLONIC STENT HAS BEEN IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE DESCENDING COLON 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, DURING PROCEDURE, THE STENT WAS HALFWAY DEPLOYED WHEN IT SUDDENLY SLIPPED FROM THE DELIVERY SYSTEM AND FULLY DEPLOYED NOT IN THE TARGET LOCATION. REPORTEDLY, THE STENT REMAINS IMPLANTED, THERE WAS NO ATTEMPTED TO REMOVE THE MIS-DEPLOYED STENT AND ANOTHER WALLFLEX COLONIC STENT WAS PLACED 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 Consequences Or Impact To Patient

  MAUDE report 7827559 ↗