WallFlex™ Biliary M00570640Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08714729756231), received between Jan 6, 2017 and Sep 4, 2026 — classified as 1 death, 20 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Material Deformation; Packaging Problem

  It was reported to Boston Scientific Corporation that a Wallflex Biliary RX Uncovered Stent was intended to be used on an unspecified date.A break/fracture was reported during transit or upon receipt at the hospital. It was reported that the stents were found damaged during shipping. There was no patient involvement.***Additional Information Received in August 05, 2026 and September 08, 2026***It was reported that the damage was observed on the package itself. The observed damage as to the packaging of the box and onto the packaging of the device. There was a distinct smell noted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600643 ↗
• InjuryMar 18, 2026Device Stenosis

  BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM AND A WALLFLEX BILIARY RX UNCOVERED STENT THROUGH THE ARTICLE, PTBD-EDGE RENDEZVOUS FOR MALIGNANT BILIARY OBSTRUCTION AND AFFERENT LOOP SYNDROME IN SURGICALLY ALTERED ANATOMY AFTER FAILURE OF CONVENTIONAL APPROACHES, BY ESMA ZYNEP KIZILASLAN, ET AL. ACCORDING TO THE ARTICLE, A PERCUTANEOUS DRAIN WAS PLACED, AND THE AFFERENT LOOP WAS FILLED WITH WATER TO ENABLE ENDOSCOPIC ULTRASOUND-GUIDED GASTROENTEROSTOMY USING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM. THROUGH THIS ACCESS, EDGE WITH PTBD RENDEZVOUS ALLOWED SUCCESSFUL PLACEMENT OF A WALLFLEX BILIARY RX UNCOVERED STENT FOR DEFINITIVE DECOMPRESSION. ELEVEN MONTHS LATER, THE STENT DYSFUNCTION FROM TUMOR INGROWTH AND WAS EFFECTIVELY TREATED WITH EDGE-ASSISTED INTRADUCTAL RADIOFREQUENCY ABLATION. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635100 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 10X60 MM WALLFLEX BILIARY UNCOVERED STENT WAS SUCCESSFULLY IMPLANTED IN THE BILE DUCT FOR THE TREATMENT OF PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2026, THE PATIENT PRESENTED WITH ELEVATED BILIRUBIN LEVELS, AND GASTRIC OUTLET OBSTRUCTION (GOO) WAS SUSPECTED. CLINICAL EVALUATION REVEALED THAT THE PREVIOUSLY IMPLANTED WALLFLEX BILIARY UNCOVERED STENT WAS OCCLUDED DUE TO TISSUE INGROWTH. A SUBSEQUENT ERCP PROCEDURE WAS PERFORMED. DURING THIS PROCEDURE, THE FIRST PORTION OF THE DUODENUM WAS DILATED TO ADDRESS THE GOO. AN ATTEMPT WAS MADE TO DEPLOY A 10X60 MM WALLFLEX BILIARY COVERED STENT WITHIN THE OBSTRUCTED STENT (STENT-IN-STENT TECHNIQUE). HOWEVER, THE COVERED STENT FAILED TO BE RELEASED PROPERLY FROM THE DELIVERY CATHETER. THE DEVICE WAS REMOVED PARTIALLY DEPLOYED FROM THE PATIENT, AND A SECOND WALLFLEX BILIARY STENT OF THE SAME SIZE WAS SUCCESSFULLY DEPLOYED, ALLOWING THE PROCEDURE TO BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED IN ASSOCIATION WITH THIS EVENT.

  Patient problems: Hyperbilirubinemia

  MAUDE report 24377433 ↗
• MalfunctionOct 3, 2025Difficult to Remove; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED IN THE BILE DUCT TO TREAT A 2CM MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT DILATED AND WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, A NON-BSC GUIDEWIRE WAS USED INSIDE THE DUCT AND THE USER WANTED TO CHANGE IT. HOWEVER, THE WIRE WOULD NOT EXIT OUT OF THE STENT SYSTEM. IT WAS ALSO REPORTED THAT THE STENT LOOKED IMPERFECT AT THE END OF THE RETRIEVING LOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214031 ↗
• MalfunctionAug 6, 2025Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem; Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A BILE DUCT TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP), WITH ENDOSCOPIC NASOBILIARY DRAINAGE PROCEDURE (ENBD) AND ENDOSCOPIC SPHINCTEROTOMY PROCEDURE (EST) PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A FOREIGN OBJECT IN THE CHANNEL, AND THE GUIDEWIRE COULD NOT BE ADVANCED. 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. NOTE: A PHOTOGRAPH WAS PROVIDED BY THE COMPLAINANT SHOWING THAT THE GUIDEWIRE ACCESS SLEEVE (GAS) RAMP WAS LIFTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727062 ↗
• MalfunctionApr 21, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED IN THE BLIE DUCT TO TREAT A SHORT BILIARY STRICTURE DUE TO PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, THE DISTAL PART OF THE STENT DID NOT EXPAND. THE STENT REMAINS IN PLACE, AND THE PHYSICIAN HAS NO PLAN TO REMOVE IT AT THIS TIME, OPTING INSTEAD TO WAIT FOR THE BILIRUBIN LEVELS TO DECREASE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873448 ↗
• MalfunctionApr 2, 2025Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY UNCOVERED STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT HAD ALREADY BEEN DEPLOYED WHILE THE GUIDEWIRE WAS BEING PASSED. THERE WERE NO KNOWN PATIENT COMPLICATIONS DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756267 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED IN THE DUODENUM, COMMON BILE DUCT AND PAPILLA TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING UNPACKING, THE STENT WAS NOTED TO BE BROKEN AND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 19, 2025. IT WAS REPORTED THAT THE DEVICE WAS UNPACKED AND THEN INSERTED INSIDE THE PATIENT. THE PHYSICIAN THEN NOTICED THAT THE STENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360234 ↗
• MalfunctionMay 8, 2024Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY UNCOVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT AN APPROXIMATELY 2CM STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024 . THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN AN INCORRECT LOCATION. CONSEQUENTLY, THE STENT WAS REMOVED WITH A SNARE. THE PROCEDURE WAS CANCELLED AS THE SAME DEVICE WAS UNAVAILABLE. 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 19274137 ↗
• InjuryJul 24, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT A WALLFLEX BILIARY UNCOVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, THERE WAS DIFFICULTY IN REMOVING THE DELIVERY SYSTEM. THE PHYSICIAN ATTEMPTED TO RESHEATH THE STENT SEVERAL TIMES BUT IT WAS STUCK AND THE DELIVERY SYSTEM WAS STILL UNABLE TO BE REMOVED. A RAT-TOOTH FORCEPS WAS THEN USED TO REMOVE THE STENT ALONG WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING PLASTIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17382865 ↗
• MalfunctionNov 18, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, PRIOR TO STENT DEPLOYMENT, THE PHYSICIAN FELT THAT THE STENT'S LENGTH WAS NOT THE LABELED LENGTH. THE STENT APPEARED TO BE TOO LONG INSIDE THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827211 ↗
• MalfunctionSep 13, 2022Use of Device Problem; Failure to Advance; Material Deformation; Use of Device Problem; Failure to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A MALIGNANT STRICTURE DUE TO PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM UP INTO THE BILIARY DUCT. THE DEVICE WAS REMOVED FORM THE PATIENT AND THE PROCEDURE WAS CANCELLED. THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY FOR PERCUTANEOUS DRAINAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED THROUGH THE CELL OF A DUODENAL STENT. HOWEVER, THE WALLFEX BILIARY RX UNCOVERED STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, WARNING: PASSING A SECOND STENT DELIVERY SYSTEM, THROUGH A JUST DEPLOYED STENT IS NOT RECOMMENDED AND COULD CAUSE THE STENT TO DISLODGE. THE USER DID NOT TAKE NOTE OF THE WARNING SET FORTH IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414995 ↗
• InjuryJan 11, 2022Break; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Break; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, WHEN THE STENT WAS ATTEMPTED TO BE RECAPTURED, THE HANDLE OF THE DELIVERY SYSTEM BROKE AND THE TIP DETACHED INSIDE THE PATIENT. THE DETACHED TIP WAS REMOVED WITH FORCEPS AND SNARES. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY UNCOVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO PROVIDED BY THE COMPLAINANT OF THE DEVICE AFTER THE PROCEDURE SHOWED THE TIP WAS DETACHED, THE CLEAR OUTER SHEATH WAS KINKED, THE OUTER BLUE SHEATH WAS BUCKLED AND THE HANDLE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13224731 ↗
• MalfunctionOct 13, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT HILAR STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING A ROUTINE FOLLOW-UP, IT WAS NOTED THAT THE STENT NATURALLY MIGRATED OUT OF THE PATIENT. REPORTEDLY, IT WAS UNKNOWN IF THE STRICTURE RESOLVED. NO NEW DEVICE WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628288 ↗
• MalfunctionOct 13, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 21, 2021 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT HILAR STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING A ROUTINE FOLLOW-UP, IT WAS NOTED THAT THE STENT NATURALLY MIGRATED OUT OF THE PATIENT. REPORTEDLY, IT WAS UNKNOWN IF THE STRICTURE RESOLVED. NO NEW DEVICE WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628250 ↗
• InjurySep 14, 2021Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX UNCOVERED 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 NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, THE STENT MOVED OUT ITS CORRECT POSITION. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT WITH BIOPSY FORCEPS; HOWEVER, THE STENT WAS UNABLE TO BE REMOVED. A 10X80 WALLFLEX BILIARY STENT WAS IMPLANTED STENT-IN-STENT INSIDE THE ORIGINAL STENT TO BRIDGE THE PAPILLA AND PROVIDE PATENCY. THE PHYSICIAN IS COMFORTABLE LEAVING THE ORIGINAL STENT 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 12467539 ↗
• MalfunctionJun 12, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2020 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A 3CM MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, THE STENT MOVED DEEPER INTO THE DUCT IMMEDIATELY AFTER THE SCOPE WAS REMOVED. REPORTEDLY, THE STENT REMAINS IMPLANTED BECAUSE IN THE PHYSICIAN'S ASSESSMENT REMOVING THE STENT MAY HAVE COMPLICATED THE PROCEDURE. A DIFFERENT STENT WAS USED 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 STABLE. AN X-RAY PHOTOGRAPH OF THE DEVICE PROVIDED BY THE COMPLAINANT SHOWS A SECOND SUCCESSFULLY IMPLANTED STENT BELOW THE MISPOSITIONED STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10148202 ↗
• InjuryApr 30, 2020Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 10, 2020 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PHYSICIAN HAD PLACED THE PATIENT UNDER FLUOROSCOPY AND MEASURED THE STRICTURE TO OBTAIN THE EXACT SIZE OF THE STENT TO BE USED DURING PROCEDURE. IT WAS REPORTED THAT THE PATIENT NEEDED A 10MMX60MM WALLFLEX BILIARY STENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, IT WAS NOTICED THAT THE STENT WAS TOO LONG. THE STENT WAS REMOVED FROM THE PATIENT AND WAS MEASURED. PER THE PHYSICIAN, THE STENT LENGTH WAS 100MM INSTEAD OF 60MM FROM THE LABELED LENGTH. DESPITE EFFORTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10014645 ↗
• MalfunctionMar 16, 2020Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 21, 2020 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS TOO LONG WHILE ON THE CATHETER. IN THE PHYSICIAN'S OPINION, THE STENT SIZE WAS LONGER THAN THE LABELLED LENGTH INDICATED ON THE BOX. REPORTEDLY, THE ISSUE WAS FOUND OUTSIDE OF THE PATIENT AND STENT DEPLOYMENT WAS NOT ATTEMPTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY UNCOVERED STENT OF A DIFFERENT SIZE. 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 9835520 ↗
• InjuryDec 12, 2019Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 20, 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS REPOSITIONED AND THE END WIRE BROKE. 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 AND STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9461046 ↗
• InjuryNov 1, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 07, 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE STENT WAS INITIALLY IMPLANTED TO TREAT SUSPECTED CANCER; HOWEVER, LATER DETERMINED THE PATIENT HAD AUTOIMMUNE PANCREATITIS AND DID NOT HAVE CANCER. ACCORDING TO THE COMPLAINANT, AS A RESULT, THE PHYSICIAN DETERMINED IT WAS A MISTAKE TO HAVE IMPLANTED AN UNCOVERED STENT AND DECIDED TO REMOVE THE STENT. ON (B)(6) 2019, AN ERCP WAS PERFORMED TO REMOVE THE WALLFLEX UNCOVERED STENT BUT THE STENT COULD NOT BE REMOVED. ON (B)(6) 2019 A COVERED STENT WAS PLACED INSIDE THE UNCOVERED STENT TO FACILITATE STENT REMOVAL. A SECOND ATTEMPT TO REMOVE THE UNCOVERED STENT WAS PERFORMED DURING AN ERCP ON (B)(6) 2019; HOWEVER, THE PHYSICIAN WAS NOT ABLE TO FIND THE COVERED STENT SO A LONGER STENT WAS IMPLANTED INSIDE. ON (B)(6) 2019, DURING A THIRD ERCP TO ATTEMPT TO REMOVE THE UNCOVERED STENT THE TWO COVERED STENTS WERE SUCCESSFULLY REMOVED BUT THE UNCOVERED STENT WAS UNABLE TO BE REMOVED. THE PATIENT HAS REPORTED EXPERIENCIN

  Patient problems: Injury; No Code Available; Weight Changes

  MAUDE report 9267398 ↗
• InjuryOct 21, 2019Difficult 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 SEPTEMBER 30, 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT HAS BEEN IMPLANTED TO TREAT A 2-3 CM MALIGNANT STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS NO TIGHTER THAN A NORMAL STRICTURE AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, DURING REMOVAL OF THE CATHETER, THE DELIVERY SYSTEM BROKE INSIDE THE PATIENT. REPORTEDLY, THE DETACHED PART OF THE DELIVERY SYSTEM WAS REMOVED WITH FORCEPS AND THE STENT REMAINS IMPLANTED. 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 9214719 ↗
• InjuryOct 17, 2019Break; Premature Activation; Use of Device Problem; Material Deformation; Break; Premature Activation; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 26, 2019 THAT A WALLFLEX BILIARY RX FULLY UNCOVERED STENT WAS TO BE USED TO TREAT A BILIARY CONSTRICTION DURING A BILIARY TRACT DEVICE INSERTION WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DELIVERY SYSTEM BROKE AND THE STENT PREMATURELY DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT 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 STABLE. A PHOTO OF THE COMPLAINT DEVICE WAS RECEIVED, AND UPON REVIEW IT WAS NOTED THAT THE BLUE OUTER SHEATH WAS BROKEN AT THE RX PORT AND THE INNER SHAFT WAS KINKED. NOTE: ACCORDING TO THE COMPLAINANT, THE ANATOMY/ LESION LOCATION WAS PERCUTANEOUS. PER THE DIRECTIONS FOR USE (DFU), AN ENDOSCOPE WITH MINIMUM 3.2 MM WORKING CHANNEL IS REQUIRED EQUIPMENT FOR THE USE OF THE DEVICE, AND THE STENT IS INTENDED TO BE ADVANCED THROUGH THE SCOPE ("THE SYSTEM SHOULD BE ADVANCED THROUGH THE ENDOSCOPE USING SHORT, CONTROLLED, 2-3 CM MOVEMENTS."). ADDITIONAL INFORMATION RECE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205588 ↗
• MalfunctionNov 12, 2018Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FRONT HANDLE DID NOT MOVE, AND REPORTEDLY, SOMETHING THAT "SNAP" WAS FELT DURING ATTEMPTED DEPLOYMENT. THE STENT WAS REMOVED OUTSIDE THE PATIENT FULLY COVERED BY THE OUTER SHEATH, AND NOTICED THE OUTER SHEATH WAS DISCONNECTED NEAR THE RX PORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8060405 ↗
• MalfunctionNov 1, 2018Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN TRIED TO LOAD THE STENT OVER THE WIRE, BUT THE GUIDEWIRE WOULD NOT COME OUT OF 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 FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE. NOTE: THIS EVENT HAS BEEN DEEMED A MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHAFT WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8027993 ↗