WallFlex Biliary M00570360Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 08714729953173), received between Oct 12, 2017 and Feb 12, 2026 — classified as 22 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE CAUSED BY CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2025. THE ANATOMY OF THE PATIENT WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. AFTER THE STENT WAS IMPLANTED, IT WAS OBSERVED THAT THE LOOPED PULL WIRE WAS DETACHED. DUE TO THIS, THE STENT WIRE WAS EXPOSED. THE STENT WAS THEN REMOVED USING A RESCUE COMBO RAT TOOTH FORCEPS AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 20, 2026 THE STENT WAS INTENDED TO BE IMPLANTED IN THE COMMON BILE DUCT. THE ANATOMY OF THE PATIENT WAS NOT TORTUROUS. THE STRICTURE PRESENTED WITH A SIZE OF 2 CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324975 ↗
• MalfunctionMay 16, 2025Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED FOR AN UNKNOWN INDICATION DURING A BILIARY STENTING CASE PERFORMED ON AN UNKNOWN DATE. PRIOR TO PROCEDURE, AFTER OPENING THE BOX AND TRYING TO REMOVE THE PLASTIC PIECE FROM THE TIP OF THE STENT, THE STENT STARTED DEPLOYING, AND THE PLASTIC PIECE WAS UNABLE TO BE REMOVED. ANOTHER WALLFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040824 ↗
• InjuryJul 9, 2024Break; Difficult to Remove; Migration; Device Stenosis; Break; Difficult to Remove; Migration; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX FULLY COVERED BILIARY RMV STENT WAS IMPLANTED IN THE DISTAL BILE DUCT FOR 2 MONTHS TO RELIEVE BILIARY OBSTRUCTION ON (B)(6) 2024. ON (B)(6) 2024, A WALLFLEX FULLY COVERED BILIARY RMV STENT WAS PLACED IN THE BILE DUCT TO RELIEVE BILIARY OBSTRUCTION DUE TO INTRADUCTAL PAPILLARY MUCINOUS NEOPLASM (IPMN). THE PATIENT RETURNED ON MARCH 13 DUE TO OBSTRUCTION. IT WAS FOUND THAT THE STENT HAD MIGRATED PROXIMALLY AND THERE WAS A DISTAL TISSUE INGROWTH. ANOTHER STENT WAS PLACED THROUGH THE ORIGINAL OCCLUDED STENT. ON (B)(6) 2024, THE PATIENT WAS BROUGHT BACK TO TRY TO REMOVE BOTH STENTS. THE SECOND STENT WAS REMOVED WITHOUT ISSUE, HOWEVER, THE MIGRATED STENT RETRIEVAL WIRE SNAPED WHILE TRYING TO REMOVE. SPYGLASS WAS PASSED THROUGH TO VISUALIZE THE PROXIMAL END OF THE STENT AND ATTEMPTED TO PULL FROM THAT END, HOWEVER, THE RETRIEVAL WAS UNSUCCESSFUL, AND THE STENT REMAINS IMPLANTED. ANOTHER SURGERY WAS SCHEDULED FOR INTRADUCTAL PAPILLARY MUCINOUS NEOPLASM (IPMN) TO REMOVE THE STENT. ADDITIONAL INFORMATION RECEIVED ON JULY 25, 2024. THE STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705621 ↗
• MalfunctionJun 20, 2024Break; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Difficult to Advance; Break; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT BILIARY STRICTURE AND STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO ADVANCE THROUGH THE DISTAL PORTION OF THE SCOPE AND IT CAME APART INSIDE THE SCOPE. THE STENT WAS REMOVED WITH DIFFICULTY AND ANOTHER WALLFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND IT WAS OBSERVED THAT THE STENT WAS PARTIALLY DEPLOYED, AND THE TIP AND THE OUTER SHEATH WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19577579 ↗
• InjuryJan 24, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS IMPLANTED IN THE COMMON BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2024, DURING A ROUTINE FOLLOW-UP, AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WAS PERFORMED AND IT WAS CONFIRMED THROUGH FLUOROSCOPY THAT THE STENT HAD MIGRATED PROXIMALLY INTO THE DUCT. SUBSEQUENTLY, THE STENT WAS REMOVED WITH FORCEPS AND A NON-BOSTON SCIENTIFIC STENT WAS PLACED 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 18574980 ↗
• InjuryJan 12, 2024Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, WHEN THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED, THE INTERNAL CATHETER GOT STUCK INSIDE THE STENT AND PULLED THE STENT OUT OF POSITION INTO THE DUODENUM. THE STENT WAS REMOVED USING RAT TOOTH GRASPING FORCEPS, AND ANOTHER WALLFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. 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 18504591 ↗
• MalfunctionDec 4, 2023Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX FULLY COVERED BILIARY STENT RMV WAS IMPLANTED IN THE DUODENUM TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY PLACED. HOWEVER, WHEN THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED, THE CATHETER GOT STUCK INSIDE THE STENT CAUSING THE STENT TO MOVE OUT OF ITS PLACE. THE STENT WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX FULLY COVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18258559 ↗
• InjuryApr 26, 2023Break; Premature Activation; Break; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, WHEN THE STENT WAS DEPLOYED, THE HANDLE BROKE. SUBSEQUENTLY, THE STENT PREMATURELY DEPLOYED AND WAS REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820186 ↗
• MalfunctionDec 8, 2022Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT AN UNDIAGNOSED STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE WALLFLEX BILIARY STENT WOULD NOT DEPLOY EVEN THOUGH THE RECONSTRAINMENT LIMIT HAS BEEN REACHED AS SEEN UNDER FLUOROSCOPY. THE WALLFLEX BILIARY DEVICE WAS REMOVED FROM THE PATIENT AND THE WALLFLEX BILIARY STENT WAS FOUND ON THE FLOOR. A DIFFERENT 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 15942252 ↗
• InjuryOct 10, 2022Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT AN APPROXIMATELY 3CM MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2022, DURING AN EMERGENT FOLLOW-UP, THE PATIENT PRESENTED WITH ELEVATED BILIRUBIN LEVEL (ABNORMAL LIVER FUNCTION TEST AND/OR BLOOD COUNT). AN ERCP PROCEDURE WAS PERFORMED, AND IT WAS FOUND THAT THE WALLFLEX BILIARY STENT HAD MIGRATED DISTALLY OUT OF THE COMMON BILE DUCT AND WAS UNABLE TO BE LOCATED. ACCORDING TO THE PHYSICIAN, THE STRICTURE WAS NOT RESOLVED AT THE TIME OF MIGRATION. A PLASTIC STENT WAS IMPLANTED FOR BILIARY DECOMPRESSION AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 15571415 ↗
• MalfunctionJul 6, 2022Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 13, 2022 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED IN THE COMMON BILE DUCT FOR INDETERMINANT STRICTURE PRIOR TO LIVER TRANSPLANT DURING A PROCEDURE PERFORMED ON (B)(6) 2022. THE STENT WAS PLANNED TO BE REMOVED DURING THE SURGICAL PROCEDURE. DURING THE LIVER TRANSPLANT PROCEDURE, THE WALLFLEX BILIARY STENT WAS ATTEMPTED TO BE REMOVED. HOWEVER, THE WALLFLEX BILIARY STENT COULD NOT BE FELT OR LOCATED. ON JUNE 13, 2022, UPON EVALUATION OF THE AMPULLA WITH AN ESOPHAGOGASTRODUODENOSCOPY (EGD) SCOPE PRIOR TO ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), IT WAS DETERMINED THE WALLFLEX BILIARY STENT HAD MIGRATED. FLUOROSCOPY WAS PERFORMED IN THE ABDOMEN AND THE WALLFLEX BILIARY STENT COULD NOT BE FOUND. IN THE PHYSICIAN'S ASSESSMENT, THE WALLFLEX BILIARY STENT MAY HAVE PASSED NATURALLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940902 ↗
• MalfunctionNov 29, 2021Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, THE PHYSICIAN NOTICED THAT THE STENT WAS DIRTY AND THAT THE RAPID EXCHANGE FUNCTION DID NOT WORK. REPORTEDLY, THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882665 ↗
• InjuryNov 16, 2021Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2021. REPORTEDLY, THE STENT WAS SCHEDULED TO BE REMOVED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE STENT REMOVAL PROCEDURE, THE STENT BEGAN TO UNRAVEL AND WAS DIFFICULT TO REMOVE. REPORTEDLY, THE STENT WAS ABLE TO BE REMOVED EXCEPT FOR A BROKEN STENT WIRE THAT WAS LEFT IN THE DUCT. THE PATIENT WAS THEN TRANSFERRED TO A DIFFERENT FACILITY FOR REMOVAL OF THE UNRETRIEVED WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824139 ↗
• MalfunctionMay 24, 2021Break; Difficult to Remove; Use of Device Problem; Human-Device Interface Problem; Material Deformation; Break; Difficult to Remove; Use of Device Problem; Human-Device Interface Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 05, 2021 THAT A WALLFLEX BILIARY RX FULLY COVERED BILIARY RMV STENT WAS IMPLANTED IN THE BILE DUCT TO TREAT BILIARY STONES/ STRICTURE DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2021, DURING A SCHEDULED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT REMOVAL PROCEDURE, THE STENT WAS ATTEMPTED TO BE REMOVED. UPON REMOVAL OF THE STENT, IT WAS NOTED THAT THE STENT WAS COVERED IN HYPERPLASTIC TISSUE. DURING REMOVAL, THE STENT BECAME UNRAVELED AND BROKE APART. EVENTUALLY, THE BROKEN PIECES WERE SUCCESSFULLY REMOVE FROM THE PATIENT USING RAT TOOTH FORCEPS AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED TO TREAT BILIARY STONES. HOWEVER, PER THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM RMV, THE STENT IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLAMS, RELIEF OF MALIGNANT BILIARY OBSTRUCTION PRIOR TO SURGERY AND FOR INDWELL UP TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872496 ↗
• MalfunctionMar 25, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 01, 2021 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT HAS BEEN IMPLANTED IN THE COMMON BILE DUCT (CBD) TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY INSIDE THE PATIENT. HOWEVER, DURING CATHETER REMOVAL, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE THROUGH THE DEPLOYED STENT AND FROM THE SCOPE. THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE STENT SEVERAL TIMES AND ATTEMPTED SEVERAL DIFFERENT SCOPE POSITIONS; EVENTUALLY THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. AFTER THE DELIVERY SYSTEM WAS REMOVED IT WAS NOTED THAT THE DELIVERY SYSTEM WAS BENT. THE STENT REMAINS 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 11567951 ↗
• MalfunctionFeb 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT DEPLOYED DAMAGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. DESPITE NUMEROUS ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 11282466 ↗
• MalfunctionFeb 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT DEPLOYED DAMAGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. DESPITE NUMEROUS ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 11282463 ↗
• MalfunctionFeb 4, 2021Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 15, 2021 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT A PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT DUE TO A PANCREATIC MASS AND WAS DILATED WITH A 4X4 HURRICANE BALLOON PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT DEPLOYED PREMATURELY INSIDE THE PATIENT AND THE STENT DID NOT BRIDGE THE AMPULLA. REPORTEDLY, THE PHYSICIAN FELT COMFORTABLE LEAVING THE STENT IMPLANTED. ANOTHER WALLFLEX BILIARY STENT WAS PLACED STENT-IN-STENT TO BRIDGE THE AMPULLA 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 11279404 ↗
• InjuryJan 5, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN AN INCORRECT POSITION. THE PHYSICIAN ADJUSTED THE PLACEMENT OF THE STENT WITH A RAT TOOTH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

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

  MAUDE report 11116313 ↗
• InjuryNov 30, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT INTRAHEPATIC BILIARY STRICTURE IN THE DISTAL BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) 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 WALLFLEX BILIARY RX FULLY COVERED STENT WAS DEPLOYED. THE PHYSICIAN DEPLOYED AN EPIC STENT PROXIMAL TO THE WALLFLEX BILIARY STENT; HOWEVER, AFTER DEPLOYMENT OF THE EPIC STENT, THE WALLFLEX STENT MOVED FROM THE ITS CORRECT POSITION IN THE BILE DUCT INTO THE DUODENUM. THE WALLFLEX STENT WAS REMOVED WITH ALLIGATOR FORCEPS AND THE PROCEDURE WAS REPORTED TO BE 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 Consequences Or Impact To Patient

  MAUDE report 10920171 ↗
• InjuryOct 28, 2020Use of Device Problem; Activation Failure; Use of Device Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 05, 2020 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED TO TREAT STONES IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, THE DISTAL PART OF THE STENT FAILED TO EXPAND. THE STENT WAS REMOVED USING RAT TOOTH FORCEPS AND ANOTHER WALLFLEX BILIARY 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. NOTE: ACCORDING TO THE COMPLAINANT, THE WALLFLEX BILIARY STENT WAS PLACED TO TREAT STONES IN THE PAPILLA. THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM RMV IS INDICATED FOR PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS, RELIEF OF MALIGNANT BILIARY OBSTRUCTION PRIOR TO SURGERY AND FOR INDWELL UP TO 12 MONTHS IN THE TREATMENT OF BENIGN BILIARY STRICTURES SECONDARY TO CHRON

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10751894 ↗
• InjuryOct 15, 2020Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STENOSIS AND BILIARY JAUNDICE IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY INSIDE THE BILE DUCT WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, THE TIP OF THE DELIVERY SYSTEM WAS CAUGHT INSIDE THE STENT AND PULLED THE STENT OUT OF ITS CORRECT POSITION. THE STENT WAS REMOVED FROM THE PATIENT WITH A SNARES AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683841 ↗
• MalfunctionMay 14, 2020Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE USED TO TREAT A 2CM MALIGNANT PANCREATIC TUMOR IN THE DISTAL COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS EXTREMELY DIFFICULT TO UNSHEATH. AFTER MINIMAL DEPLOYMENT INSIDE THE PATIENT, THE STENT WAS FULLY RECONSTRAINED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT COVER WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10055995 ↗
• InjuryMar 19, 2020Difficult or Delayed Positioning; Difficult to Remove; Positioning Problem; Difficult or Delayed Positioning; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE STENT. REPORTEDLY, AFTER THE PHYSICIAN DEPLOYED THE STENT, AS THE PHYSICIAN REMOVED THE CATHETER, THE FULLY DEPLOYED STENT GOT CAUGHT ON THE DELIVERY SYSTEM AND MOVED THE STENT OUT OF THE CORRECT POSITION. THE PHYSICIAN HAD TO RETRIEVE THE STENT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ADVANIX BILIARY 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9853878 ↗
• InjuryFeb 26, 2020Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TO TREAT A MALIGNANT STRICTURE FROM CHRONIC PANCREATITIS PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE STENT WAS ABLE TO BE DEPLOYED WITHOUT ISSUE BUT IT WAS NOTED THAT THE STENT WAS NOT FULLY EXPANDED. THE STENT WAS REMOVED WITH GRASPERS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9753037 ↗