WallFlex™ Duodenal M00565030Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08714729456506), received between Mar 7, 2017 and Feb 27, 2025 — classified as 2 deaths, 11 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (8 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED TO TREAT A 3-7 MM MALIGNANT LESION IN THE DUODENUM DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND REPORTEDLY PRESENTED WITH ABDOMINAL PAIN. DURING THE PROCEDURE, THE STENT TIP BECAME DEFORMED (CURVED). THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER WALLFLEX ENTERAL DUODENAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21484644 ↗
• InjuryOct 8, 2024Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE USED IN THE DUODENUM DURING AN IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED, BUT IT FULLY DEPLOYED IN AN INCORRECT LOCATION. THE STENT WAS THEN ATTEMPTED TO BE REMOVED, BUT DIFFICULTY WAS ALSO ENCOUNTERED WHICH CAUSED OBSTRUCTION OF THE RESPIRATORY TRACT. THE PROCEDURE WAS NOT COMPLETED BECAUSE THE PATIENT EXPERIENCED RESPIRATORY DISTRESS, AND THE PATIENT WAS THEN TREATED WITH ADDITIONAL OXYGEN SUPPLEMENTS. IN THE PHYSICIAN'S ASSESSMENT THE STENT CAUSED THE OBSTRUCTION OF THE AIRWAY. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE FOR RESPIRATORY TRACT MONITORING AND THE PATIENT IS EXPECTED TO FULLY RECOVER. NOTE: IT WAS REPORTED THAT THE STENT CAUSED OBSTRUCTION OF THE RESPIRATORY TRACT. THE IFU STATES, " THE WALLFLEX DUODENAL STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE DEVICE IS INDICATED FOR THE PALLIATIVE TREATMENT OF GASTRODUODENAL OBSTRUCTIONS PRODUCED BY MALIGNANT NEOPLASMS." THE WALLFLEX DUODENAL STENT IS NOT INDICATED TO BE USED IN THE RESPIRATORY TRACT.

  Patient problems: Airway Obstruction; Respiratory Insufficiency

  MAUDE report 20400620 ↗
• InjuryJun 21, 2024Migration; Device Stenosis; Migration; Device Stenosis

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES REFERENCED IN THE ARTICLE. PLEASE REFER TO MANUFACTURER'S REF # 3005099803-2024-02914 FOR THE HOT AXIOS, AND MANUFACTURER'S REF # 3005099803-2024-02915 FOR THE WALLFLEX DUODENAL STENT. BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENTS THAT INVOLVE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM AND WALLFLEX DUODENAL DEVICES THROUGH AN ARTICLE TITLED, "PROPENSITY SCORE-MATCHED RETROSPECTIVE COHORT STUDY OF ENDOSCOPIC ULTRASOUND-GUIDED GASTROENTEROSTOMY AND ENTERAL STENTING FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION", BY NADINE SEITZ ET AL. THE STUDY AIMS TO FURTHER INVESTIGATE AND COMPARE THE USE OF ENTERAL STENTING AND ENDOSCOPIC ULTRASONOGRAPHY TO PERFORM GASTROENTEROSTOMY (EUS-GE) FOR THE ENDOSCOPIC MANAGEMENT OF MALIGNANT GASTRIC OUTLET OBSTRUCTION (GOO). TECHNICAL FAILURE OCCURRED SIGNIFICANTLY MORE FREQUENTLY IN THE ENTERAL STENTING GROUP (13/44) COMPARED WITH EUS-GE GROUP (4/44). A RETROSPECTIVE STUDY WAS CONDUCTED ON PATIENTS FOR THE TREATMENT OF GASTRIC OUTLET OBSTRUCTION USING TWO DIFFERENT METHODS AND 2 DIFFERENT DEVICES. AN UNCOVERED SELF-EXPANDABLE METAL STENT (WALLFLEX DUODENAL STENT) WAS USED FOR

  Patient problems: Aspiration/Inhalation; Hemorrhage/Blood Loss/Bleeding; Pneumonia

  MAUDE report 19584377 ↗
• MalfunctionJun 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX DUODENAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT THERE WAS SEVERE SHORTENING OF THE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461773 ↗
• InjuryMay 6, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A MALIGNANT 8-CM DUODENAL ILEUS DURING A DUODENAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN AN INCORRECT LOCATION. THE STENT WAS ATTEMPTED TO BE REMOVED USING AN ADDITIONAL DEVICE, BUT IT COULD NOT BE REMOVED. THE STENT REMAINS IMPLANTED, BUT A NEW PROCEDURE WAS SCHEDULED TO REMOVE THE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250324 ↗
• DeathJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING A WALLFLEX DUODENAL STENT THROUGH THE ARTICLE, "AORTODUODENAL FISTULA FROM DUODENAL STENTING FOR MALIGNANT GASTRIC OBSTRUCTION," BY ELENI BACOPANOS, ET AL. PER THE ARTICLE, WALLFLEX DUODENAL STENTS WERE IMPLANTED TO TREAT GASTRIC OUTFLOW OBSTRUCTION SECONDARY TO METASTATIC ADENOCARCINOMA. INDICATION WAS AORTODUODENAL FISTULA (ADF) IN ALL THREE PATIENTS. ALL PATIENTS PRESENTED WITH UPPER GASTROINTESTINAL (GI) BLEEDING AND UNDERWENT ENDOVASCULAR AORTIC STENT GRAFT REPAIR (EVAR), WITH TEMPORARY AORTIC BALLOON OCCLUSION IN ONE CASE. THE SECOND PATIENT DIED TWO DAYS AFTER THE PROCEDURE FROM SEPSIS RELATED COMPLICATIONS. 2 YEARS POST STENT PLACEMENT, THE PATIENT FOR THE SECOND CASE REPORT PRESENTED WITH COLLAPSE AND BLEEDING INTO PATIENT'S ILEOSTOMY BAG. PATIENT WAS NORMOTENSIVE AND HYPERTHERMIC. THE PATIENT WAS GIVEN ANTIBIOTICS. AN INITIAL TRIPHASIC COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) WAS PERFORMED AND RESULTS SHOWED NO CONTRAST EXTRAVASATION INTO THE DUODENUM. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE WITH FURTHER FRESH GASTROINTESTINAL (GI) BLEEDING AND WAS TRANSFERRED TO A TERTIARY FACILITY FOR OESOPHAGOGASTRODUODENOSCOPY (OGD). DESP

  Patient problems: Cardiac Arrest; Erosion; Fever; Hematoma; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Sepsis; Thrombosis/Thrombus

  MAUDE report 18581655 ↗
• DeathJan 25, 2024Device Stenosis; Device Stenosis

  BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING A WALLFLEX DUODENAL STENT THROUGH THE ARTICLE, "AORTODUODENAL FISTULA FROM DUODENAL STENTING FOR MALIGNANT GASTRIC OBSTRUCTION," BY ELENI BACOPANOS, ET AL. PER THE ARTICLE, WALLFLEX DUODENAL STENTS WERE IMPLANTED TO TREAT GASTRIC OUTFLOW OBSTRUCTION SECONDARY TO METASTATIC ADENOCARCINOMA. INDICATION WAS AORTODUODENAL FISTULA (ADF) IN ALL THREE PATIENTS. ALL PATIENTS PRESENTED WITH UPPER GASTROINTESTINAL (GI) BLEEDING AND UNDERWENT ENDOVASCULAR AORTIC STENT GRAFT REPAIR (EVAR), WITH TEMPORARY AORTIC BALLOON OCCLUSION IN ONE CASE. ALL CASES WERE SUCCESSFUL IN ACHIEVING HEMOSTASIS. THE FIRST CASE, ALTHOUGH INITIALLY COMPLICATED BY ACUTE STENT THROMBOSIS OF THE RIGHT ILIAC LIMB, WAS DISCHARGED TO A REHABILITATION FACILITY AND SURVIVED FOR TWO YEARS. 7 MONTHS POST STENT PLACEMENT, THE PATIENT FOR THE FIRST CASE REPORT, PRESENTED WITH HEMATEMESIS AND COLLAPSE. PATIENT WAS IN SHOCK WITH DISTENDED ABDOMEN AND DECREASED HEMOGLOBIN COUNT DESPITE HAVING RECEIVED THREE UNITS OF PACKED RED BLOOD CELLS (PRBC). INTRAVENOUS (IV) FLUID RESUSCITATION WITH PROPHYLACTIC ANTIBIOTICS WAS ADMINISTERED. TRIPHASIC COMPUTED TOMOGRAPHY ANGIOGRAM WAS PERFORME

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Low Blood Pressure/ Hypotension; Shock; Thrombosis/Thrombus; Vomiting

  MAUDE report 18581459 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED IN THE INTESTINAL TRACT TO TREAT A MALIGNANT 9 CM INTESTINAL STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS. ON (B)(6) 2023, POST-PROCEDURE, PRIOR TO DISCHARGE OF THE PATIENT, THE STENT WAS NOTICED TO HAVE DISLODGED AND MIGRATED FROM THE ANATOMICAL IMPLANT SITE. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS, AND ANOTHER WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. 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 17911388 ↗
• InjuryAug 28, 2023Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED TO TREAT AN 8CM MALIGNANT INTESTINAL STENOSIS IN THE INTESTINAL TRACT DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6), 2023. THE PATIENT'S ANATOMY WAS NOTED TO BE TORTUOUS. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH THE SYMPTOM OF BEING UNABLE TO EAT. THIS PROMPTED THE PHYSICIAN TO CHECK THE STENT PLACEMENT AND IT WAS NOTED THAT THE STENT MIGRATED. THE STENT WAS REMOVED WITH BIOPSY FORCEPS, AND ANOTHER WALLFLEX ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON AUGUST 29, 2023. IT WAS REPORTED THAT THE STENT WAS IMPLANTED ON (B)(6) 2023. ON (B)(6), 2023, STENT MIGRATION WAS NOTED. ON THE SAME DAY, THE MIGRATED STENT WAS REMOVED, AND ANOTHER STENT WAS IMPLANTED. THE PATIENT ALSO EXPERIENCED CONSTIPATION DUE TO STENT MIGRATION.

  Patient problems: Constipation; Feeding Problem

  MAUDE report 17635103 ↗
• MalfunctionAug 1, 2023Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 13, 2023, THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A MALIGNANT DUODENAL STENOSIS DUE TO CANCER DURING A DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE WHITE HANDLE BROKE AND THE STENT DID NOT DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS NOT COMPLETED. TWO (2) DAYS LATER, ANOTHER WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED IN THE PATIENT. REPORTEDLY, THE PATIENT EXPERIENCED CONSTIPATION; HOWEVER, THERE IS NO AVAILABLE INFORMATION TO CONFIRM THAT A MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED OUTSIDE THE SCOPE OF THE ORIGINAL PROCEDURE OR THAT THE REPORTED MALFUNCTION OF THE WALLFLEX ENTERAL DUODENAL STENT CAUSED OR CONTRIBUTED TO THE PATIENT'S CONSTIPATION. ADDITIONALLY, THE PATIENT WAS NOT ADMITTED BEYOND THE STANDARD DAYS OF HOSPITAL CARE.

  Patient problems: Constipation

  MAUDE report 17436518 ↗
• MalfunctionJun 26, 2023Unsealed Device Packaging; Unsealed Device Packaging

  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 MFR. REPORT # 3005099803-2023-03452). A DIFFERENT SIZE WALLFLEX DUODENAL STENT (THE SUBJECT OF THIS REPORT) 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 17198358 ↗
• InjuryJun 15, 2023Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 29, 2023, THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED IN THE PYLORUS AND DUODENUM TO TREAT A 4 CM MALIGNANT DUODENAL STRICTURE DURING A DUODENAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, A WALLFLEX DUONDENAL STENT WAS ABLE TO BE DEPLOYED. HOWEVER, IT WAS NOTED THAT THERE WAS NO RADIAL EXPANSION AT THE STRICTURE SITE. THE PATIENT WAS OBSERVED FOR 48 HOURS, BUT THERE WAS STILL NO RADIAL EXPANSION OF THE STENT. ON (B)(6) 2023, CRE DILATION OF THE STENT WAS PERFORMED. THE PHYSICIAN IS COMFORTABLE LEAVING THE STENT IMPLANTED AND THE PHYSICIAN IS PLANNING TO PLACE ANOTHER STENT AT THE SAME STRICTURE SITE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137812 ↗
• MalfunctionMar 27, 2023Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED TO TREAT A 4-5MM STRICTURE IN THE DUODENUM DURING A FIBROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT WAS BLOCKED WHEN BEING DEPLOYED AND THE OLIVE TIP BROKE. 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 APRIL 04, 2023 THE PHYSICIAN HAD A FEELING THAT THE DISTAL OLIVE TIP BROKE; HOWEVER, WHEN THE DEVICE WAS VISUALLY CHECKED, THERE WERE NO VISIBLE PROBLEMS NOTED ON THE OLIVE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620683 ↗
• MalfunctionJan 12, 2023Break; Activation, Positioning or Separation Problem; Material Deformation; Break; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A 3 CM EXTRINSIC MALIGNANT DUODENAL STRICTURE DUE TO PANCREATIC CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH 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 DELIVERY HANDLE SNAPPED IN TWO PLACES, AND THE CONTROL HUB WAS NOTED TO BE BROKEN. THE WALLFLEX DUODENAL STENT WAS UNABLE TO FULLY DEPLOY AND WAS REMOVED FROM THE PATIENT PARTIALLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS SCHEDULED FOR ANOTHER STENT PLACEMENT AT ANOTHER HEALTHCARE FACILITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE STAINLESS-STEEL HANDLE WAS SLIGHTLY BENT, THE BLUE OUTER SHEATH WAS SEPARATED FROM THE EXTERIOR TUBE HANDLE, AND THE WALLFLEX DUODENAL STENT WAS PARTIALLY DEPLOYED OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16151972 ↗
• InjuryAug 8, 2022Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 18, 2022 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED TO TREAT AN APPROXIMATELY 5 CM MALIGNANT STRICTURE IN THE DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE WALLFLEX DUODENAL STENT WAS DEPLOYED IN THE CORRECT LOCATION. DURING REMOVAL OF THE WALLFLEX DUODENAL DELIVERY SYSTEM, THE DELIVERY SYSTEM GOT CAUGHT ON THE WALLFLEX DUODENAL STENT. AS THE PHYSICIAN CONTINUED TO WITHDRAW THE DELIVERY SYSTEM, THE DELIVERY SYSTEM PULLED THE WALLFLEX DUODENAL STENT AND EVENTUALLY THE WALLFLEX DUODENAL STENT MOVED OUT OF PLACE. THE WALLFLEX DUODENAL STENT WAS REMOVED FROM THE PATIENT WITH RAT- TOOTH GRASPING FORCEPS AND A 22 X 90 WALLFLEX DUODENAL STENT WAS IMPLANTED 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 15186628 ↗
• MalfunctionJul 13, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ENTERAL STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT GASTRIC OUTLET OBSTRUCTION IN THE DUODENUM DURING A DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE WALLFLEX ENTERAL STENT COULD NOT BE DEPLOYED AS THE STEEL ROD BECAME TWISTED. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS NOT COMPLETED DUE TO DEVICE AVAILABILITY. THERE WERE NO PATIENT COMPLICATIONS DUE TO 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 15005223 ↗
• MalfunctionJun 30, 2022Positioning Failure; Failure to Advance; Material Integrity Problem; Positioning Failure; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED TO TREAT A 6-8CM MALIGNANT GASTRIC OUTLET OBSTRUCTION (GOO) IN THE DUODENUM DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND TIGHT. DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN THE DEVICE WAS ADVANCED THROUGH THE STRICTURE AND THE TIP OF THE STENT CATHETER GOT BENT. CONSEQUENTLY, THE STENT WAS UNABLE TO DEPLOY AND WAS FULLY COVERED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. DILATATION WAS PERFORMED AND ANOTHER WALLFLEX DUODENAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. FURTHERMORE, THE PHYSICIAN SENT THE PATIENT FOR A GASTROJEJUNOSTOMY PROCEDURE DUE TO A VERY TIGHT STRICTURE IN THE GASTRIC OUTLET. 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 14879303 ↗
• MalfunctionMar 15, 2022Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-01217 AND # 3005099803-2022-01218 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2022 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED TO TREAT AN INTESTINAL OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2022-01217 ) DID NOT DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. AFTER STENT REMOVAL, IT WAS NOTED THAT THE STENT WAS KINKED. A SECOND WALLFLEX DUODENAL STENT WAS USED (THE SUBJECT OF THIS REPORT); HOWEVER, AGAIN THE STENT DID NOT DEPLOY AND THE STENT WAS FOUND KINKED AFTER REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX DUODENAL 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 13772345 ↗
• MalfunctionMar 15, 2022Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-01218 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 17, 2022 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED TO TREAT AN INTESTINAL OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE STENT (THE SUBJECT OF THIS REPORT) DID NOT DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. AFTER STENT REMOVAL, IT WAS NOTED THAT THE STENT WAS KINKED. A SECOND WALLFLEX DUODENAL STENT WAS USED (THE SUBJECT OF MFR. REPORT # 3005099803-2022-01218); HOWEVER, AGAIN THE STENT DID NOT DEPLOY AND THE STENT WAS FOUND KINKED AFTER REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX DUODENAL 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 13772344 ↗
• MalfunctionDec 29, 2021Failure to Advance; Difficult to Advance; Appropriate Device Problem Term/Code Not Available; Failure to Advance; Difficult to Advance; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE DUODENUM FROM PANCREATIC MASS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) 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 GUIDEWIRE WAS UNABLE TO ADVANCE THROUGH THE STENT DELIVERY SYSTEM. A DIFFERENT STIFFER GUIDEWIRE WAS ATTEMPTED BUT AGAIN THE GUIDEWIRE WAS UNABLE TO ADVANCE THROUGH THE STENT DELIVERY SYSTEM. THE PHYSICIAN PRELOADED THE STENT INTO THE SCOPE WITH THE GUIDEWIRE; HOWEVER, THE DELIVERY SYSTEM WAS UNABLE TO ADVANCE AND CROSS THE STRICTURE. THE PROCEDURE WAS NOT COMPLETED AND WILL BE RESCHEDULED WHERE A SHORTER SCOPE WILL BE USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112129 ↗
• InjuryDec 17, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 26, 2021 THAT A WALLFLEX DUODENAL STENT WAS IMPLANTED TO TREAT AN APPROXIMATELY 9 CM MALIGNANT INTESTINAL STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON NOVEMBER 25, 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. ON (B)(6) 2021, POST STENT PLACEMENT, THE PATIENT PRESENTED WITH VOMITING. COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND CONFIRMED THE STENT MIGRATED. THE STENT WAS REMOVED FROM THE PATIENT USING GASTROSCOPE AND THE PROCEDURE WAS COMPLETED ANOTHER WALLFLEX DUODENAL STENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Vomiting

  MAUDE report 13025370 ↗
• InjuryNov 29, 2021Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTFIIC CORPORATION ON (B)(6), 2021 THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED FOR STONES EXTRACTION DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN PLACING THE STENT IN THE TARGET LOCATION. THE STENT WAS REMOVED AND THE PROCEDURE WAS REPORTED TO BE SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 03, 2022 AND FEBRUARY 07, 2022** THE STENT WAS IMPLANTED IN THE DUODENUM TO TREAT A DUODENAL STENOSIS. THE PATIENT WAS THEN TREATED FOR STONES IN THE BILE DUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882263 ↗
• MalfunctionSep 22, 2021Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 01, 2021 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STENOSIS IN THE DUODENUM DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE STENT WAS DEPLOYED INSIDE THE SCOPE. THE STENT WAS REMOVED FROM THE SCOPE USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512619 ↗
• 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 # 3005099803-2021-01145 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 THIS REPORT) 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 MFR. REPORT# 3005099803-2021-01145 ) WAS DEPLOYED. THE STENT DEPLOYED PREMATURELY AND WAS PLACED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516249 ↗
• MalfunctionMar 15, 2021Break; Positioning Failure; Appropriate Device Problem Term/Code Not Available; Break; Positioning Failure; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A 10 CM PANCREATIC CANCER DURING A DUODENAL PROSTHESIS PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE DISTAL HANDLE DETACHED FROM THE CATHETER PREVENTING THE STENT TO DEPLOY. THE PROCEDURE WAS NOT COMPLETED BECAUSE ANOTHER WALLFLEX DUODENAL STENT WAS NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484122 ↗