WallFlex™ Biliary M00570530Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 08714729764915), received between Dec 8, 2016 and Sep 30, 2026 — classified as 1 death, 27 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949566 ↗
• InjuryJul 27, 2026Positioning Problem

  It was reported to Boston Scientific Corporation that a Wallflex Biliary RX Covered Stent was implanted in the biliary tract to treat a biliary stenosis during a stent placement procedure performed on (b)(6) 2026. Post procedure, it was noted that the stent was dislodged. The device was removed, and a different 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 50047758 ↗
• MalfunctionMay 7, 2026Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026, IT WAS REPORTED THAT DURING UNPACKING OUTSIDE THE PATIENT, THE TIP OF THE STENT WAS FOUND BENT. ANOTHER WALFLEX BILIARY STENT WAS USED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 25119167 ↗
• MalfunctionFeb 16, 2026Positioning Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A BILE DUCT STENOSIS DURING A BILIARY STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. ANOTHER OF THE SAME DEVICE 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. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT STENT FAILED TO EXPAND. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345665 ↗
• MalfunctionJan 21, 2026Difficult to Advance; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED INTO THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON DECEMBER 26, 2025. DURING THE PROCEDURE, A RADIOLOGIST USED THE PREVIOUSLY ESTABLISHED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHIC DRAINAGE PATHWAY FROM THE RIGHT INTRAHEPATIC DUCT OF THE LIVER TO PLACE THE METAL STENT. DURING DEPLOYMENT, THE DELIVERY SYSTEM BECAME SLIGHTLY STUCK, PREVENTING THE STENT FROM FULLY DEPLOYING. IN AN ATTEMPT TO REPOSITION AND FACILITATE DEPLOYMENT, THE PHYSICIAN MANIPULATED THE STENT BACK AND FORTH. THIS MANEUVER INADVERTENTLY CAUSED THE STENT TO MIGRATE ENTIRELY INTO THE COMMON BILE DUCT. THE PROXIMAL OPENING OF THE STENT WAS NOT ALIGNED WITH THE PAPILLA, COMPROMISING ITS INTENDED FUNCTION. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON JANUARY 25, 2026. IT WAS REPORTED THAT THE ANATOMY OF THE PATIENT WAS TORTUROUS AND THE ANATOMY OF THE PATIENT WAS NOT DILATED. THE SIZE OF THE LESION WAS OBSERVE

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130739 ↗
• InjuryJan 20, 2026Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED TO THE BILE DUCT TO TREAT A STRICTURE MEASURING APPROXIMATELY 11 MM CAUSED BY CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED AROUND (B)(6) 2025. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. TWO MONTHS POST PROCEDURE, DURING A FOLLOW UP EXAMINATION, IT WAS FOUND THAT THE STENT HAD MIGRATED INTO THE DUODENUM. THE MIGRATED STENT WAS REMOVED ON THE SAME DAY USING FORCEPS. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119423 ↗
• MalfunctionAug 5, 2025Break; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Break; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED IN THE BILIARY TRACT TO TREAT A MALIGNANT TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT COULD NOT BE FULLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT RETRIEVAL LOOP WAS BROKEN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715080 ↗
• MalfunctionJan 30, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, WHILE OPENING THE PACKAGE, THERE WAS AN AIR LEAKAGE, AND IT COULD NO LONGER BE USED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE AIR LEAKAGE WAS FOUND IN THE DEVICE PACKAGING AND FROM THE SEAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273487 ↗
• InjuryNov 26, 2024Break; Difficult to Remove; Use of Device Problem; Migration; Break; Difficult to Remove; Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS IMPLANTED IN THE BILE DUCT TO ADDRESS A PERSISTENT BILE LEAK DURING A PROCEDURE PERFORMED IN (B)(6) 2023. IN (B)(6) 2024, THE PATIENT RETURNED TO THE HOSPITAL FOR STENT REMOVAL. DURING THE PROCEDURE, THE STENT APPEARED BROKEN, WITH THE PROXIMAL PART HAVING MIGRATED AND PASSED OUT OF THE PATIENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED BLEEDING, AND A SECOND STENT WAS PLACED TO ACHIEVE HEMOSTASIS. THE FIRST STENT REMAINED IMPLANTED. ON (B)(6) 2024, THE PATIENT RETURNED AGAIN FOR STENT REMOVAL. DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, BOTH STENTS WERE SUCCESSFULLY REMOVED USING PED BIOPSY FORCEPS. A SPYGLASS WAS USED TO CHECK FOR ANY RETAINED PRODUCT, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED DURING THE SECOND STENT REMOVAL. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, SHOWING TWO STENTS OUTSIDE THE PATIENT. THE FIRST STENT WAS BROKEN IN HALF. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY STENT WAS IMPLANTED FOR A PERSISTENT BILE LEAK. HOWEVER, THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATE:

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20780922 ↗
• InjurySep 23, 2024Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Material Integrity Problem; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS USED FOR STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PROCEDURE PERFORMED ON (B)(6) , 2024. DURING THE PROCEDURE, A SEVERE STENOSIS IN THE COMMON BILE DUCT (CBD) WAS TREATED BY DILATING THE AREA WITH A HURRICANE BALLOON. A WALLFLEX STENT WAS THEN DEPLOYED ACROSS THE STENOSIS, BUT THE PROXIMAL PORTION OF THE STENT REMAINED CRIMPED ON THE INTERNAL STENT CATHETER. DESPITE ATTEMPTS TO PASS ANOTHER WIRE AND WAIT FOR RADIAL EXPANSION, THE STENT REMAINED STUCK. WHEN THE PHYSICIAN TRIED TO REMOVE THE CATHETER WITH CONSIDERABLE FORCE, THE CATHETER TIP BROKE OFF AND LODGED IN THE STENT, AS CONFIRMED BY FLUOROSCOPY. THE CATHETER WAS REMOVED. ON (B)(6) 2024, A SECOND PROCEDURE WAS SCHEDULED, AND THE LODGE TIP WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20277840 ↗
• InjuryJul 15, 2024Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY COVERED STENT WAS TO BE IMPLANTED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE STENT DID NOT EXPAND. 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 19743001 ↗
• InjuryApr 22, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY COVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO FULLY EXPAND. CONSEQUENTLY, THE STENT'S POSITION WAS ADJUSTED BUT IT WAS STUCK AND COULD NOT BE MOVED. THE STENT WAS REMOVED WITH A FOREIGN BODY 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155297 ↗
• InjuryMar 14, 2024Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY COVERED STENT RMV WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A MALIGNANT STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED. HOWEVER, IT WAS FOUND THAT SEVERAL STENT WIRES WERE BLOCKING THE OPENING OF THE DEVICE, AND STENT WIRES WERE EXPOSED TO THE DRAINAGE MOUTH. THE POSITION WAS ADJUSTED USING BIOPSY FORCEPS, AND THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. 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 18909273 ↗
• InjuryNov 1, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY COVERED STENT WAS USED TO TREAT A CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, AFTER THE STENT DEPLOYMENT, IT WAS NOTED THAT THE DISTAL PORTION OF THE STENT WAS MOVED TO THE COMMON BILE DUCT. THE STENT WAS THEN REPOSITIONED USING FORCEPS AND ANOTHER WALLFLEX BILIARY 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 18047572 ↗
• MalfunctionJul 19, 2023Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A BENIGN .05 CM OBSTRUCTION OF THE BILIARY TRACT DURING A METAL BILIARY STENT IMPLANTATION UNDER PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE WALLFLEX BILIARY STENT COULD NOT BE DEPLOYED PROPERLY. THE STENT WAS REMOVED FROM THE PATIENT AND THE STENT'S WIRE WAS FOUND TO BE BROKEN. ANOTHER WALLFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED TO TREAT A BENIGN 0.5 CM TUMOR. PER THE INSTRUCTIONS FOR USE (IFU), THE DEVICE IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS AND RELIEF OF MALIGNANT BILIARY OBSTRUCTION PRIOR TO SURGERY, AND IT IS CONTRAINDICATED FOR PLACEMENT IN BILIARY STRICTURES CAUSED BY BENIGN TUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350730 ↗
• MalfunctionJun 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 11, 2023, THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT "SHORTENING WAS TOO SEVERE". 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17210910 ↗
• InjuryMar 17, 2023Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX BILIARY RX COVERED STENT WAS IMPLANTED TO TREAT A 3CM MALIGNANT STRICTURE IN THE BILIARY TRACT DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2023. POST STENT PLACEMENT, THE PATIENT PRESENTED WITH FEVER, NAUSEA, VOMITING, ELEVATED BILIRUBIN LEVEL AND YELLOWING OF THE SKIN. IT WAS NOTED THAT THE STENT MIGRATED FROM ITS ORIGINAL LOCATION. THE STENT WAS REMOVED FROM THE PATIENT WITH BIOPSY FORCEPS. ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Fever; Jaundice; Nausea; Vomiting

  MAUDE report 16565248 ↗
• InjuryJan 13, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX BILIARY COVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A 3CM MALIGNANT STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) 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, POST STENT DEPLOYMENT, WHEN THE PATIENT WAS REVIEWED, STENT DISPLACEMENT WAS NOTED THROUGH IMAGING. CONSEQUENTLY, THE STENT WAS REMOVED FROM THE PATIENT WITH BIOPSY 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 FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161423 ↗
• InjuryOct 26, 2022Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A BENIGN STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE WALLFLEX BILIARY STENT WAS ABLE TO BE DEPLOYED; HOWEVER, IT WAS NOTED THAT THE SILICONE COVERING THE INNER WALL OF THE WALLFLEX BILIARY STENT WAS DAMAGED. THE WALLFLEX BILIARY STENT WAS REMOVED FROM THE PATIENT WITH RAT-TOOTH FORCEPS AND ANOTHER WALLFLEX BILIARY 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. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY COVERED STENT WAS TO BE IMPLANTED TO TREAT A BENIGN STRICTURE. PER THE INSTRUCTIONS FOR USE (IFU), "THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS AND RELIEF OF MALIGNANT BILIARY OBSTRUCTION PRIOR TO SURGERY". TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15676529 ↗
• MalfunctionSep 23, 2021Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT CHOLEDOCHAL STENOSIS AFTER LIVER TRANSPLANT IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT STENOSIS WAS SEVERE AND THE ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE COMPLETELY DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. 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 AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE STENT COVER WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519032 ↗
• InjuryApr 13, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED IN THE BILIARY TRACT TO TREAT A MALIGNANT BILIARY STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED INSIDE THE PATIENT; HOWEVER, THE PHYSICIAN NOTED A HOLE ON THE STENT COVER. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS AND ANOTHER WALFLEX BILIARY 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 11655352 ↗
• InjuryJan 21, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STENOSIS IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, AFTER THE STENT WAS DEPLOYED, THE DELIVERY SYSTEM COULD NOT BE REMOVED. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE DELIVERY SYSTEM, BUT THE INNER SHEATH DETACHED AND WAS STUCK IN THE DUODENUM. REPORTEDLY, THE STENT AND THE DETACHED INNER SHEATH WERE REMOVED FROM THE PATIENT WITH A SNARE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THE STENT PLACEMENT PROCEDURE HAS BEEN RESCHEDULED. 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 11207632 ↗
• MalfunctionJul 30, 2020Positioning Failure; Material Integrity Problem; Activation Failure; Positioning Failure; Material Integrity Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STENOSIS IN THE LOWER SEGMENT OF THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE OUTER SHEATH FELT STUCK AND THE STENT FAILED TO DEPLOY. REPORTEDLY, THE DELIVERY SYSTEM FAILED TO UNSHEATHE THE STENT. 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 AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE STENT COVER WAS DAMAGED AND THE STENT FAILED TO EXPAND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10346797 ↗
• MalfunctionJun 11, 2020Break; Use of Device Problem; Difficult to Advance; Material Integrity Problem; Break; Use of Device Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT A CHOLANGIOCARCINOMA IN THE DISTAL COMMON BILE DUCT DURING A BILIARY METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHIPPING MANDREL WAS MANUALLY REMOVED PRIOR TO LOADING THE GUIDEWIRE. DURING THE PROCEDURE, THE GUIDEWIRE FAILED TO PASS THROUGH THE SIDE HOLE OF THE DELIVERY CATHETER. REPORTEDLY, THE PHYSICIAN ATTEMPTED TO REMOVE AND RE-INSERT THE CATHETER OVER THE GUIDEWIRE BUT COULD NOT GET THE GUIDEWIRE EXIT AT THE RX PORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT, AND PER INITIAL REVIEW OF THE PHOTO, THE OUTER SHEATH WAS DETACHED. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WIRE WAS BROKEN AND A HOLE WAS NOTED ON THE STENT COVER. PLEASE SEE FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143086 ↗
• MalfunctionMay 11, 2020Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP) PROCEDURE PERFORMED ON (B)(4) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER ADVANCING TO THE BIOPSY CHANNEL, THE STENT FULLY DEPLOYED PREMATURELY INSIDE THE SCOPE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10043059 ↗