WallFlex Biliary M00570380Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08714729953197), received between Mar 19, 2018 and May 21, 2026 — classified as 21 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (11 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC (BSC) ON (B)(6) 2026, IN CONNECTION WITH LEGAL PROCEEDINGS, BECAME AWARE OF AN ALLEGED EVENT THAT OCCURRED OVER 3 YEARS AGO. THE ALLEGATIONS DESCRIBED HEREIN HAVE NOT BEEN CONFIRMED INDEPENDENTLY BY BSC, AS BSC HAS NOT RECEIVED OTHER CORROBORATING DOCUMENTATION OR INFORMATION OUTSIDE OF THE LEGAL PROCEEDINGS RELATED TO THE ALLEGATIONS. THE GASTROENTEROLOGIST AND HIS ATTORNEY INVOLVED IN THE LEGAL PROCEEDINGS COMMUNICATED TO BSC THAT A WALLFLEX FULLY COVERED REMOVABLE (RMV) 10 MM BY 8 CM (WALLFLEX) STENT WAS DEPLOYED ON (B)(6) 2023 (DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)) TO TREAT A STRICTURE FORMED BY MISPLACEMENT OF A SURGICAL CLIP USED TO TREAT BLEEDING OF THE CYSTIC ARTERY, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED ON (B)(6) 2023. UPON FURTHER INVESTIGATION, BSC LOCATED THE FILED LEGAL COMPLAINT WITH THE DISTRICT COURT OF BOULDER, COLORADO AGAINST THE PATIENT'S HEALTHCARE PROVIDERS, INCLUDING THE GASTROENTEROLOGIST. IN THIS LEGAL COMPLAINT, IT WAS ALLEGED THAT THE GASTROENTEROLOGIST DEVIATED FROM THE STANDARD OF CARE IN THAT HE FAILED TO APPROPRIATELY PLACE THE BILIARY STENT AND FAILED TO USE THE APPROPRIATE TYPE AND SIZE OF STENT

  Patient problems: Abscess; Biliary Leak; Erosion; Hemorrhage/Blood Loss/Bleeding; Hyperbilirubinemia; Jaundice; Perforation; Unspecified Infection

  MAUDE report 25249803 ↗
• InjuryApr 27, 2026Use of Device Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED STENT RMV WAS TO BE IMPLANTED TO TREAT A BILE LEAK IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, IT WAS NOTED THAT THE PROXIMAL FLANGE OPENED OUTSIDE THE AMPULLA, WHILE THE DISTAL FLANGE DID NOT OPEN. THE PHYSICIAN ATTEMPTED TO RECAPTURE THE STENT TO FACILITATE PROPER DEPLOYMENT; HOWEVER, THE DISTAL FLANGE REMAINED UNOPENED. AN EXTRACTOR BALLOON WAS SUBSEQUENTLY USED IN AN ATTEMPT TO OPEN THE STENT, BUT THIS MANEUVER WAS UNSUCCESSFUL. THE STENT WAS THEN REMOVED USING FORCEPS, AND THE PROCEDURE WAS COMPLETED USING A PLASTIC STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: ACCORDING TO THE COMPLAINANT, THE WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS PLACED TO TREAT A BILE LEAK. HOWEVER, PER THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM RMV DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002447 ↗
• InjuryFeb 13, 2026Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED TO THE BILE DUCT TO TREAT A STRICTURE CAUSED BY CANCER DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) , 2026. THE ANATOMY OF THE PATIENT WAS TORTUOUS BUT WAS NOT DILATED PRIOR TO STENT PLACEMENT. PATIENT HAD ELEVATED LIVER FUNCTION. DURING THE PROCEDURE, A STENT DEPLOYMENT PROBLEM OCCURRED. THE DEVICE WAS REMOVED USING SNARES. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT HAS FULLY RECOVERED. ***ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 19, 2026*** THE PROCEDURE PERFORMED DID NOT CAUSE THE ELEVATED LIVER FUNCTION SEEN IN THE PATIENT.

  Patient problems: Liver Damage/Dysfunction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332649 ↗
• InjuryJun 18, 2025Difficult or Delayed Positioning; Positioning Problem; Difficult or Delayed Positioning; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY DEPLOYING THE STENT. ALTHOUGH THE STENT WAS EVENTUALLY DEPLOYED, IT MIGRATED BELOW THE TARGET LOCATION. THE STENT WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. HOWEVER, THE PATIENT EXHIBITED ELEVATED LIVER FUNCTION TEST RESULTS.

  Patient problems: Liver Damage/Dysfunction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286781 ↗
• MalfunctionMar 31, 2025Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENTS WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED, BUT THE STENT WOULD NOT COME OFF THE SHEATH. ANOTHER WALLFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHEATH WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730574 ↗
• MalfunctionMar 20, 2025Unsealed Device Packaging; Use of Device Problem; Packaging Problem; Unsealed Device Packaging; Use of Device Problem; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX STENT SYSTEM WAS TO BE IMPLANTED TO THE BILE DUCT TO TREAT A CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CARDBOARD EXTERIOR BOX FOR THE METAL STENT WAS OPENED AND UPON INSPECTION OF INTERNAL SEALED PACKAGE, THERE WAS A SMALL OPENING. IT WAS NOTED THAT THE BOX HAD SOME AREAS OF WEAR AT THE CORNERS. DUE TO THE DAMAGED PACKAGING, THE STERILITY OF THE PRODUCT WAS COMPROMISED. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: USERS ARE STRONGLY ADVISED BY THE DFU NOT TO USE A STENT PAST THE EXPIRATION DATE ON THE PACKAGE INSERT. HOWEVER, THE DEVICES ARE TESTED BEYOND THE EXPIRATION DATE ON THE PACKAGE AND PER MEDICAL SAFETY; THE ADDITIONAL REASONABLY EXPECTED RISK OF THE USE OF THIS EXPIRED PRODUCT IS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21658896 ↗
• MalfunctionDec 31, 2024Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE 10X80 WALLFLEX BILIARY STENT WAS DEPLOYED; HOWEVER, IT WAS NOTED THAT IT WAS TOO BIG. SUBSEQUENTLY, A 10X60 STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21049064 ↗
• InjuryOct 29, 2024Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED TO TREAT CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT DID NOT FORESHORTEN AS EXPECTED AND WAS FOUND TO BE TOO LONG. THE STENT WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON OCTOBER 30, 2024*** IT WAS REPORTED THAT THE WALLFLEX BILIARY STENT WAS INTENDED FOR IMPLANTATION IN THE BILE DUCT. HOWEVER, THE STENT WAS FOUND TO BE TOO LONG FOR THE PATIENT'S ANATOMY AND WAS SUBSEQUENTLY REMOVED USING A RAT TOOTH RETRIEVAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559693 ↗
• InjuryJul 15, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON JUNE 19, 2024, AN ATTEMPT WAS MADE TO REMOVE THE STENT FOR AN EXCHANGE; HOWEVER, THE STENT FRAYED DURING THE REMOVAL. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, SHOWING THAT THE STENT WIRES WERE BROKEN AND THE STENT ITSELF WAS DEFORMED. THE STENT WAS ABLE TO BE SUCCESSFULLY REMOVED AND ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742868 ↗
• InjuryJun 3, 2024Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A BENIGN POST LIVER TRANSPLANT ANASTOMOTIC STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS SLIGHTLY DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, THE STENT MOVED OUT OF ITS POSITION AND MIGRATED BELOW THE STRICTURE. THE STENT WAS REMOVED WITH FORCEPS AND A DIFFERENT SIZE WALLFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THERE WAS NO MALIGNANCY IN THE INTENDED ANATOMY. PER THE INSTRUCTIONS FOR USE (IFU), "THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM RMV IS INDICATED FOR USE IN THE 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 CHRONIC PANCREATITIS." THE STENT IS NOT INDICATED FOR AN ANATOMY WITH NO MALIGNAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455013 ↗
• InjuryMay 13, 2024Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED STENT RMV WAS IMPLANTED IN THE BILE DUCT TO TREAT A BILE LEAK POST GALL BLADDER REMOVAL DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. 6 MONTHS POST STENT PLACEMENT PROCEDURE, DURING A SCHEDULED STENT REMOVAL, THE STENT WAS ATTEMPTED TO BE REMOVED AS THE BILE LEAK WAS RESOLVED. HOWEVER, THE PHYSICIAN ENCOUNTERED DIFFICULTY IN REMOVING THE STENT. THE STENT WAS EVENTUALLY REMOVED USING RAT TOOTH FORCEPS AND CRE BALLOON, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: ACCORDING TO THE COMPLAINANT, THE WALFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED TO TREAT A LEAK IN THE COMMON BILE DUCT FOLLOWING GALLBLADDER REMOVAL. HOWEVER, PER THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM RMV DIRECTIONS FOR USE, THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM RMV IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS, RELIEF OF MALIGNANT BILIARY OBSTRUCTION PRIOR TO SURGERY AND FOR INDWELL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19303901 ↗
• InjuryMar 7, 2024Difficult to Remove; Use of Device Problem; Positioning Problem; Difficult to Remove; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS TO BE IMPLANTED IN THE BILE DUCT FOR BILE LEAKAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, WHEN THE DELIVERY WAS ATTEMPTED TO BE REMOVED, THE CATHETER GOT STUCK AT THE DISTAL PORTION OF THE STENT. THE DELIVERY SYSTEM WAS RE-SHEATHED, AND WHEN AN ATTEMPT WAS MADE AGAIN TO REMOVE THE CATHETER, THE STENT WAS PULLED OUT OF ITS POSITION. THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED, AND THE STENT WAS REMOVED USING RAT TOOTH FORCEPS. ANOTHER WALLFLEX BILIARY STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: ACCORDING TO THE COMPLAINANT, THE WALLFLEX BILIARY STENT WAS USED TO TREAT A BILE LEAK IN THE COMMON BILE DUCT. HOWEVER, PER THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PROD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861496 ↗
• MalfunctionFeb 19, 2024Activation, Positioning or Separation Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED IN THE COMMON HEPATIC DUCT TO TREAT A 1-2 MM DIAMETER X 2 CM LENGTH INDETERMINATE STRICTURE DUE TO PRIMARY SCLEROSING CHOLANGITIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH FULLY COVERED STENT PLACEMENT PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE GUIDEWIRE SHEATH DETACHED, WHICH WOULD NOT ALLOW THE STENT TO BE FULLY DEPLOYED. THE PARTIALLY DEPLOYED STENT AND THE GUIDEWIRE WERE REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF INNER SHEATH DETACHMENT OR SEPARATION. PLEASE SEE BLOCK H10 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735625 ↗
• InjuryDec 21, 2023Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT 5 CM STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED INTO THE ANATOMY. UPON REMOVAL, DIFFICULTY WAS EXPERIENCED IN RECAPTURING THE DELIVERY SYSTEM WHEN THE TIP BECAME STUCK TO THE PROXIMAL END OF THE STENT, CAUSING THE STENT TO MOVE DISTALLY AND PROTRUDE OUT INTO THE DUODENUM. ONLY 3-4 DIAMONDS WERE VISIBLE ABOVE THE STRICTURE, AND ABOUT 3 1/2 CM WERE PROTRUDING OUT INTO THE DUODENUM. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS, AND A DIFFERENT STENT 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 18377810 ↗
• InjuryOct 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, IT WAS NOTED THAT THE INNER SHEATH WAS DETACHED. THE DETACHED INNER SHEATH WAS REMOVED FROM THE PATIENT USING FORCEPS. THE STENT REMAINS IMPLANTED AND WAS CONFIRMED TO BE IN THE CORRECT LOCATION AFTER REMOVAL OF THE DETACHED INNER SHEATH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986307 ↗
• InjuryMar 29, 2023Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component; Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY IMPLANTED; HOWEVER, DURING REMOVAL, THE DELIVERY SYSTEM GOT CAUGHT IN THE STENT AND THE INNER SHEATH SNAPPED OFF OF THE DELIVERY SYSTEM. THE STENT AND THE INNER SHEATH WERE REMOVED USING FORCEPS AND THE PROCEDURE WAS COMPLETED USING ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE STENT WAS ATTEMPTED TO BE IMPLANTED TO TREAT STONES. HOWEVER, PER THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM RMV DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE IN THE 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 CHRONIC PANCREATITIS. THE DEVICE IS NOT INDICATED TO BE PLACED TO TREAT STONES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640041 ↗
• InjuryMar 8, 2023Mechanical Problem; Positioning Problem; Mechanical Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2023-01224 AND 3005099803-2023-01228 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 22, 2023, THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED INSIDE A PREVIOUSLY IMPLANTED WALLFLEX BILIARY UNCOVERED STENT TO TREAT STENT INGROWTH DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)96) 2023. DURING THE PROCEDURE, STENT INGROWTH WAS NOTED ON A PREVIOUSLY IMPLANTED WALLFLEX BILIARY UNCOVERED STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-01228). THE WALLFLEX BILIARY RX FULLY COVERED RMV STENT (THE SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE DEPLOYED INSIDE THE UNCOVERED STENT; HOWEVER, DURING DEPLOYMENT, THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE STENT TO ADJUST THE POSITION OF THE STENT, BUT THE STENT COULD NOT BE RE-SHEATHED. THE PHYSICIAN THEN PROCEEDED TO FULLY DEPLOY THE STENT AND REMOVED THE STENT USING A RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED USING A 10X60MM WALLFLEX BILIARY FULLY COVERED STENT. THERE WERE NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506349 ↗
• InjuryJan 12, 2023Difficult or Delayed Positioning; Migration; Difficult or Delayed Positioning; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS TO BE 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) 2022. DURING THE PROCEDURE, THE WALLLFEX BILIARY STENT WAS DEPLOYED WITH DIFFICULTY. FURTHERMORE, THE PATIENT PRESENTED WITH ABNORMAL LEVELS WHICH PROMPTED THE PHYSICIAN TO CHECK THE STENT. SUBSEQUENTLY, IT WAS NOTED THAT THE STENT HAD MIGRATED AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLLFEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 16151640 ↗
• InjuryMar 28, 2022Difficult or Delayed Positioning; Failure to Advance; Positioning Problem; Difficult or Delayed Positioning; Failure to Advance; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED TO TREAT A 4MM MALIGNANT BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) 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, THERE WAS DIFFICULTY CROSSING THE DELIVERY SYSTEM THROUGH THE STRICTURE. FURTHERMORE, THE STENT WAS DIFFICULT TO DEPLOY AND A HIGH AMOUNT OF FORCE WAS APPLIED TO DEPLOY THE STENT. THE STENT WAS DEPLOYED IN AN INCORRECT LOCATION AND WAS REMOVED FROM THE PATIENT WITH RAT-TOOTH FORCEPS. ANOTHER WALLFLEX BILIARY 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 13929174 ↗
• InjurySep 16, 2021Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-04831 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 26, 2021 THAT A 10X60 WALLFLEX BILIARY FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT AN APPROXIMATELY 5CM STRICTURE IN THE MIDDLE AND DISTAL COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPHINCTEROTOMY AND STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, A 10X60 WALLFLEX BILIARY FULLY COVERED STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2021-04831) WAS FULLY DEPLOYED; HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED, THE STENT ADHERED TO THE DELIVERY SYSTEM AND MOVED OUT ITS CORRECT LOCATION. CONSEQUENTLY, THE STENT WAS REMOVED AND A 10X80 WALLFLEX BILIARY STENT (THE SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE IMPLANTED. AGAIN, AFTER THE STENT WAS FULLY DEPLOYED, WHEN THE DELIVERY SYSTEM WAS REMOVED, THE STENT ADHERED TO THE DELIVERY SYSTEM AND MOVED OUT ITS CORRECT LOCATION. THE STENT WAS ALSO REMOVED AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484869 ↗
• InjuryFeb 26, 2021Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 05, 2021 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) 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 PHYSICIAN ATTEMPTED TO RECAPTURE AND REPOSITION THE STENT, BUT HE WAS UNSUCCESSFUL. THE PHYSICIAN FULLY DEPLOYED THE STENT IN AN INCORRECT LOCATION BLOCKING ONE OF TH HEPATIC DUCTS AND RETRIEVED THE STENT WITH A RAT TOOTH FORCEPS. REPORTEDLY, THE STENT WAS DIFFICULT TO REMOVE. ANOTHER WALLFLEX BILIARY 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 11388593 ↗
• MalfunctionNov 18, 2020Material Deformation; Material Deformation

  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 BILIARY OBSTRUCTION DURING A STENT IMPLANT PROCEDURE ON AN UNKNOWN DATE. ON (B)(6) 2020, AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) STENT REMOVAL PROCEDURE WAS PERFORMED. ACCORDING TO THE COMPLAINANT, DURING THE STENT REMOVAL PROCEDURE, THE PHYSICIAN NOTICED THAT THE STENT STARTED TO UNRAVEL UPON REMOVAL. REPORTEDLY, THE STENT WAS SUCCESSFULLY REMOVED USING RAT TOOTH FORCEPS AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10864425 ↗
• MalfunctionAug 26, 2020Difficult to Remove; Material Deformation; Migration; Difficult to Remove; Material Deformation; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 04, 2020 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED IN THE COMMON BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED SOMETIME IN FEBRUARY OR EARLY MARCH. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2020, DURING A SCHEDULED STENT REMOVAL PROCEDURE, IT WAS NOTED THAT THE STENT SLIGHTLY MIGRATED, THE STENT WAS DEFORMED, AND THE MIDDLE OF THE STENT WAS KINKED. THERE WAS DIFFICULTY IN REMOVING THE STENT. A FOREIGN BODY HOOD PROTECTOR WAS USED TO HELP REMOVE THE STENT WITHOUT DAMAGE TO THE PATIENT OR SCOPE. THE PHYSICIAN ATTEMPTED TO STRAIGHTEN THE STENT USING A HURRICANE BALLOON VIA DILATION AND THE STENT WAS ABLE TO BE REMOVED WITH RAPTOR FORCEPS. REPORTEDLY, THE STRICTURE WAS RESOLVED AT THE TIME OF THE MIGRATION. 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. PHOTOGRAPHS PROVIDED BY THE COMPLAINANT OF THE DEVICE AFTER REMOVAL SHOW THE STENT STRUTS AT THE PROXIMAL END OF THE STENT BENT AND STRETCHED. THE STENT WAS KINKED IN THE MIDDLE OF THE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457043 ↗
• MalfunctionApr 8, 2020Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN TH 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 DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE DELIVERY SYSTEM THROUGH THE STRICTURE. REPORTEDLY, THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT; HOWEVER, IT WAS NOTICED THAT THE TIP OF THE DELIVERY SYSTEM WAS BENT. 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 FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938258 ↗
• InjuryJan 10, 2020Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE USED IN THE COMMON BILE DUCT DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, IT WAS NOTED THAT THE STENT WAS SHORT FOR THE PATIENT'S ANATOMY. THE STENT WAS ATTEMPTED TO BE PULLED DOWN BUT THE STENT LOOKS LIKE IT KINKED. THE STENT WAS REMOVED AND ANOTHER WALLFLEX BILIARY STENT WAS PLACED 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575506 ↗