WallFlex™ Biliary M00570650Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729758150), received between Apr 26, 2017 and Mar 9, 2026 — classified as 12 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS INTENDED TO BE IMPLANTED TO TREAT AN ADVANCED CHOLANGIOCARCINOMA IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. THE PATIENT WAS A SIXTY-YEAR-OLD MALE WITH PREVIOUS DIAGNOSIS OF BILE DUCT CANCER AND BILE DUCT STENOSIS. DURING THE ATTEMPTED ERCP, THE PLAN WAS TO INSERT A METAL STENT FOR DECOMPRESSION AND DRAINAGE. AFTER PREPARING THE GUIDEWIRE AND SUCCESSFULLY INSERTING THE CATHETER, THE STENT WAS ADVANCED OVER THE GUIDEWIRE. HOWEVER, WHEN ATTEMPTING TO DEPLOY THE STENT, THE PUSHER COULD NOT BE ADVANCED OUT OF THE SHEATH NORMALLY. DESPITE REPEATED ATTEMPTS, THE STENT STILL COULD NOT BE DEPLOYED. UPON WITHDRAWAL, IT WAS FOUND THAT THE STENT WAS DAMAGED. ANOTHER WALLFLEX 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 24548049 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS 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 FAILED TO EXPAND INSIDE THE PATIENT AFTER DEPLOYMENT. CONSEQUENTLY, THE STENT WAS REMOVED USING SNARES AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF A DIFFERENT MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638990 ↗
• MalfunctionJul 31, 2025Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED FOR A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE PHYSICIAN NOTED THAT THE STENT LABELED 80MM IN LENGTH APPEARED LONGER THAN EXPECTED. 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 22681318 ↗
• InjuryJul 24, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; 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 COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE INNER SHEATH OF THE DELIVERY SYSTEM FRACTURED, LEAVING APPROXIMATELY 10 - 15 CM OF FOREIGN MATERIAL IN THE AMPULLA. IT WAS NOTED THAT THE PATIENT DID NOT HAVE A TORTUOUS ANATOMY. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED USING RAT TOOTH FORCEPS. THE DEVICE WAS NOT DIFFICULT TO REMOVE, AND THE STENT REMAINED IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22596703 ↗
• MalfunctionJul 1, 2025Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT MALIGNANT BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ERCP METAL STENTING PROCEDURE PERFORMED ON (B)(6), 2025. THE PATIENT ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT DURING THE PROCEDURE, WHILE PASSING THE STENT THROUGH THE STRICTURE THE SHEATH BECAME KINKED. THE PROCEDURE WAS CANCELLED/ RESCHEDULED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, SHOWING THE OUTER BLUE SHEATH WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373736 ↗
• MalfunctionJan 2, 2025Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILIARY METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. PRIOR TO THE PROCEDURE, THE STENT DEPLOYED AS IT WAS BEING LOADED. ANOTHER WALLFLEX BILIARY STENT WAS USED 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 21060443 ↗
• InjuryDec 12, 2023Difficult or Delayed Positioning; Difficult to Remove; Activation Failure; Difficult or Delayed Positioning; Difficult to Remove; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY UNCOVERED STENT WAS TO BE IMPLANTED IN THE COMMON 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 TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, RESISTANCE OCCURRED WHEN DEPLOYING THE STENT. THE STENT WAS EVENTUALLY DEPLOYED AND THE PHYSICIAN WAITED FOR 10 SECONDS BEFORE ATTEMPTING TO REMOVE THE DELIVERY SYSTEM; HOWEVER, THE DELIVERY SYSTEM KEPT DRAGGING THE STENT OUT OF THE DUCT WHEN ATTEMPTED TO BE REMOVED. SUBSEQUENTLY, THE PHYSICIAN TOOK ANOTHER PAUSE TO ALLOW THE STENT TO OPEN MORE BEFORE PULLING THE DELIVERY SYSTEM; HOWEVER, THE STENT DID NOT FULLY EXPAND AND MOVED OUT OF ITS POSITION WHEN THE DELIVERY SYSTEM WAS REMOVED. THE STENT WAS THEN REMOVED WITH FORCEPS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18313621 ↗
• InjuryNov 3, 2023Difficult to Remove; Use of Device Problem; Device Stenosis; Difficult to Remove; Use of Device Problem; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED IN THE COMMON BILE DUCT ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, POST STENT PLACEMENT, IT WAS NOTICED THAT THE STENT WAS EMBEDDED WITH TISSUE INGROWTH. THE WALLFLEX BILIARY UNCOVERED STENT WAS ATTEMPTED TO BE REMOVED VIA DUODENOSCOPE; HOWEVER, THE STENT COULD NOT BE REMOVED. THE WALLFLEX BILIARY UNCOVERED STENT REMAINS IN PLACE, AND ANOTHER STENT WAS IMPLANTED STENT-IN-STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT IS NOW DOING WELL. IT WAS REPORTED THAT THE STENT WAS ATTEMPTED TO BE REMOVED BECAUSE AN UNCOVERED BILIARY STENT WAS IMPLANTED IN ERROR; THE STENT WAS SUPPOSED TO BE A COVERED STENT, AND THERE WAS NO MALIGNANCY IN THE INTENDED ANATOMY LOCATION. THE STENT HAS BEEN SUCCESSFULLY REMOVED FROM THE PATIENT. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED IN AN ANATOMY LOCATION WITH NO MALIGNANCY. PER THE INSTRUCTIONS FOR USE (IFU), "THE WALLFLEX BILIARY RX UNCOVERED STENT SYSTEM IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065392 ↗
• MalfunctionDec 15, 2022Difficult 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) 2022 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STENOSIS DURING A PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS LONG AND WAS VERY TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE DISTAL PART OF THE CATHETER WAS BROKEN AND REMAINED INSIDE THE FULLY DEPLOYED STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987186 ↗
• MalfunctionNov 18, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 28, 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 15827754 ↗
• MalfunctionMay 10, 2021Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 19, 2021 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT AN INTRABILIARY STRICTURE DUE TO INFLAMMATION OF THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE DISTAL TIP OF THE STENT WAS DETACHED OUTSIDE THE PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796693 ↗
• MalfunctionMay 7, 2021Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; 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 STRICTURE IN THE BILE DUCT 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 METAL STENT WAS KINKED WHEN IT WAS ATTEMPTED TO BE DEPLOYED. REPORTEDLY, THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793772 ↗
• InjuryApr 28, 2021Difficult to Remove; Difficult to Remove

  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 BILIARY STRICTURE DUE TO CHOLANGIOCARCINOMA IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED WITH A HURRICANE BALLOON PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, THE TIP OF THE DELIVERY SYSTEM GOT CAUGHT ON THE TOP OF THE STENT IN THE HILAR REGION. THE PHYSICIAN WAS UNABLE TO REMOVE THE DELIVERY SYSTEM AND ANOTHER DEVICE COULD NOT FIT THROUGH THE SCOPE SO THE PHYSICIAN CUT THE DELIVERY SYSTEM. THE SCOPE WAS THEN ABLE TO BE REMOVED, AND THEN THE STENT AND DELIVERY SYSTEM WERE REMOVED USING A RAT TOOTH FORCEPS. REPORTEDLY, THE PHYSICIAN BELIEVES THAT THE EVENT WAS DUE TO THE STENT SIZE BEING TOO LONG FOR THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED USING A SMALLER SIZED 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 REPORTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738233 ↗
• MalfunctionNov 23, 2020Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 03, 2020 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE 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 WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT PREMATURELY DEPLOYED. REPORTEDLY, THE STENT REMAINS IMPLANTED AND THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACE. ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED 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 10884716 ↗
• InjuryNov 9, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 19, 2020 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT TUMOR 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 THE PROCEDURE, THE STENT WAS DEPLOYED. REPORTEDLY, FIFTEEN MINUTES AFTER THE STENT PLACEMENT, IMAGING WAS PERFORMED AND IT WAS NOTED THAT THE STENT WAS IN THE INCORRECT POSITION. THE STENT WAS REMOVED FROM THE DUODENUM WITH BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY UNCOVERED STENT. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10809331 ↗
• MalfunctionOct 9, 2020Difficult to Advance; Material Deformation; Material Integrity Problem; Difficult to Advance; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE MIDDLE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE WOULD NOT ADVANCE THROUGH THE STENT EVEN THOUGH THE GUIDEWIRE WAS WET AND LUBRICATED. REPORTEDLY, IT WAS NOTED THAT THE CATHETER WAS KINKED AND THE DISTAL WHITE OLIVE TIP OF THE DELIVERY SYSTEM WAS BENT DOWNWARD. THE DELIVERY SYSTEM WAS REMOVED 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 10655114 ↗
• MalfunctionAug 18, 2020Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED 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 DILATED PRIOR TO STENT PLACEMENT AND THE PATIENT HAD A TORTUOUS ANATOMY. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. 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 INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHEATH WAS DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420103 ↗
• MalfunctionJan 7, 2020Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A STENOSIS IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. REPORTEDLY, AFTER REMOVAL OF THE DEVICE, THE STENT WAS OBSERVED TO BE KINKED. 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 9559934 ↗
• InjuryOct 17, 2019Difficult to Remove; Detachment of Device or Device Component; Activation Failure; Difficult to Remove; Detachment of Device or Device Component; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT AN INTRINSIC BILE DUCT STENOSIS DUE TO CHOLANGIOCARCINOMA DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS VERY TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, DURING REMOVAL OF THE CATHETER, THE DELIVERY SYSTEM GOT STUCK IN THE MIDDLE PORTION OF THE STENT. AFTER SEVERAL ATTEMPTS TO REMOVE THE DELIVERY SYSTEM, THE DISTAL INNER SHAFT AND TIP OF THE DELIVERY SYSTEM DETACHED. REPORTEDLY, THE DETACHED PART WAS LEFT INSIDE THE STENT AND WILL BE REMOVED AT A LATER DATE. AN XRAY PHOTO OF THE STENT IN SITU WAS RECEIVED AND UPON REVIEW IT WAS NOTED THAT THE STENT DID NOT APPEAR TO BE FULLY EXPANDED WHERE THE INNER SHAFT HAD GOTTEN STUCK. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205997 ↗
• InjuryJun 7, 2019Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2019-02945, 3005099803-2019-02939, AND 3005099803-2019-02940 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE TWO RESOLUTION 360 CLIPS (THE SUBJECT OF MFR. REPORT# 3005099803-2019-02939 AND MFR. REPORT# 3005099803-2019-02940) FAILED TO ANCHOR THE WALLFLEX BILIARY RX UNCOVERED STENT (THE SUBJECT OF THIS REPORT) IN PLACE. THIS LED THE STENT TO MOVE FROM ITS ORIGINAL POSITION. THE STENT WAS REMOVED FROM THE PATIENT AND ANOTHER WALLFLEX BILIARY STENT WAS PLACED 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 Consequences Or Impact To Patient

  MAUDE report 8679852 ↗
• MalfunctionFeb 26, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS RELEASED INSIDE THE PATIENT. DURING CATHETER REMOVAL, THE DELIVERY SYSTEM GOT STUCK IN THE DISTAL PART OF THE STENT, AND THE STENT WAS PULLED OUT TOGETHER WITH THE DELIVERY SYSTEM. REPORTEDLY, THE STENT WAS NOTED TO BE BENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371474 ↗
• MalfunctionDec 13, 2018Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION 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 AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE TECH HAD FULLY DEPLOYED THE HANDLE OF THE WALLFLEX BILIARY STENT REMAINED FULLY COVERED BY THE OUTER SHEATH. THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS, WHICH REVEALED THAT THE OUTER SHEATH WAS DETACHED/BROKEN AT THE OUTER DIAMETER: PROXIMAL EXTERIOR TUBE-ENDOSCOPE INTERFACE (PROXIMAL END OF THE GUIDEWIRE ACCESS SHEATH).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8161087 ↗
• MalfunctionDec 6, 2018Break; Positioning Failure; Device-Device Incompatibility; Break; Positioning Failure; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A 4CM MALIGNANT STRICTURE IN THE MID COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT BE RELEASED OFF THE CATHETER. REPORTEDLY, THE WALLFLEX CAUGHT ON THE BIOPSY CAP DURING WITHDRAWAL FROM THE SCOPE BUT WAS ABLE TO BE REMOVED FROM THE SCOPE. ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A MDR- REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE OUTER SHEATH WAS DETACHED/ BROKEN AT THE OUTER DIAMETER: PROXIMAL EXTERIOR TUBE- ENDOSCOPE INTERFACE (PROXIMAL END OF THE GUIDEWIRE ACCESS SHEATH SECTION).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8139668 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018, THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED AS PART OF THE E7034 WALLFLEX BILIARY PRE-OPERATIVE DRAINAGE NEOADJUVANT THERAPY REGISTRY CLINICAL TRIAL. THE PATIENT WAS ENROLLED INTO THE CLINICAL TRIAL ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, BASELINE LIVER FUNCTION TESTS WERE TAKEN. ASSESSMENT OF BILIARY OBSTRUCTIVE SYMPTOMS (ABOS) WAS CONDUCTED AND THE FOLLOWING SYMPTOMS WERE REPORTED: DARK URINE, PALE STOOL, JAUNDICE AND ITCHING. A 1.9 CM ADENOCARCINOMA TUMOR WAS FOUND IN THE HEAD OF THE PANCREAS. ON (B)(6) 2015 THE PATIENT UNDERWENT A STUDY STENT PLACEMENT PROCEDURE AS AN OUTPATIENT. A BILIARY SPHINCTEROTOMY WAS PERFORMED DURING THE STENT PLACEMENT PROCEDURE AND PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. THE 10MM X 80MM WALLFLEX BILIARY RX UNCOVERED STENT WAS PLACED IN A SATISFACTORY MANNER. ON (B)(6) 2015, THE PATIENT EXPERIENCED ACUTE CHOLECYSTITIS AND AN IR GUIDED PERCUTANEOUS CHOLECYSTOSTOMY TUBE WAS PLACED. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2015. ON (B)(6) 2015, THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED. ON (B)(6) 2015, THE PATIENT UNDERWENT THE CURA

  Patient problems: Inflammation

  MAUDE report 8021254 ↗
• MalfunctionOct 17, 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 2 1/2 CM MALIGNANT LESION IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING DEPLOYMENT, A "POPPED" WAS FELT AND THE STENT WAS NOT DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. REPORTEDLY, THE BLUE OUTER SHEATH NEAR THE GUIDEWIRE ACCESS PORT WAS NOTED TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7973480 ↗