WallFlex™ Biliary M00570730Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08714729759324), received between Mar 15, 2017 and Feb 11, 2026 — classified as 1 death, 11 injuries, 18 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Premature Activation; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT A BILLIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE GUIDEWIRE WAS NOT ABLE TO BE INTRODUCED IN THE STENT. REPORTEDLY, THE STENT PREMATURELY DEPLOYED OUTSIDE THE PATIENT. 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 24315623 ↗
• InjuryAug 1, 2025Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; 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 DISTAL HEPATIC DUCT TO TREAT A STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY POSITIONED, AND THE OUTER SHEATH WAS REMOVED WITHOUT DIFFICULTY. HOWEVER, THE WHITE INNER CATHETER OF THE DELIVERY SYSTEM REMAINED FIRMLY ATTACHED TO THE METAL STENT AND COULD NOT BE DETACHED DESPITE MULTIPLE ATTEMPTS. THE PHYSICIAN PROCEEDED TO CUT THE DELIVERY SYSTEM AND INTRODUCED A DUODENOSCOPE ALONGSIDE THE CATHETER. INTRAHEPATIC PROBING WAS ACHIEVED USING A GUIDEWIRE, AND CRE BALLOON DILATION WAS PERFORMED, BUT THE CATHETER REMAINED IN PLACE. THE STENT AND INNER CATHETER WERE THEN REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE WITHOUT DIFFICULTY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22693022 ↗
• InjuryJun 19, 2025Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT FOR DRAINAGE AND TREATMENT OF AN OBSTRUCTION DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS DISLOCATED AFTER RELEASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT AND 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 22290651 ↗
• MalfunctionDec 10, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT WAS PLACED AND DEPLOYED OVER A GUIDEWIRE INTO THE DUCT; HOWEVER, THE STENT'S RETRIEVAL WIRE BECAME CAUGHT UNDER THE CATHETER OF THE STENT. SUBSEQUENTLY, THE DELIVERY SYSTEM WAS MOVED BACK AND FORTH TO DISLODGE THE RETRIEVAL WIRE FROM THE CATHETER, BUT IT REMAINED STUCK AND WRAPPED AROUND THE CATHETER, AND IT WAS UNABLE TO BE REMOVED. THE STENT WAS CONSEQUENTLY PULLED AND REMOVED TOGETHER WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A 10X60 FULLY COVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20896637 ↗
• MalfunctionNov 1, 2024Positioning Failure; Material Deformation; Material Integrity Problem; Positioning Failure; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED WAS USED TO TREAT SECONDARY CHOLANGITIS DUE TO BILIARY OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE WORKING CHANNEL, AND THE STENT DEPLOYMENT PROCESS WAS DONE; HOWEVER, THE STENT COULD NOT BE DEPLOYED, EVEN AFTER THE DEVICE REACHED THE POINT OF NO RETURN. REPORTEDLY, THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO DEVICE AVAILABILITY. SUBSEQUENTLY, THE PROCEDURE WAS RESCHEDULED ON (B)(6) 2024, USING A DIFFERENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20588825 ↗
• InjuryFeb 3, 2023Break; Defective Device; Activation, Positioning or Separation Problem; Break; Defective Device; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 09, 2023, THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED AND WAS BROKEN. THE STENT WAS REMOVED FROM THE PATIENT 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 16296609 ↗
• InjuryAug 11, 2022Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 25, 2022 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A LESS THAN 60MM BENIGN STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE WALLFLEX BILIARY STENT WAS DEPLOYED; HOWEVER, IT WAS NOTED THAT THE RETRIEVAL LOOP OF THE WALLFLEX BILIARY STENT WAS BENT. 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 FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: A PHOTO OF THE COMPLAINT DEVICE DEPLOYED INSIDE THE PATIENT WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE RETRIEVAL LOOP OF THE WALLFLEX BILIARY STENT WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214750 ↗
• DeathAug 1, 2022Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 05, 2022 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A PANCREATIC CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED IN (B)(6) 2021. POST STENT PLACEMENT, ON AN UNKNOWN DATE, A WHIPPLE PROCEDURE WAS TO BE PERFORMED; HOWEVER, IT WAS FOUND THAT THE WALLFLEX BILIARY STENT HAD ERODED TO THE INFERIOR VENA CAVA. THE WALLFLEX BILIARY STENT WAS UNABLE TO BE REMOVED AND SURGERY WAS ALSO UNABLE TO BE PERFORMED TO REMOVE THE TUMORS DUE TO THE MIGRATED STENT. THE PATIENT DIED IN (B)(6) 2022 (EXACT DATE UNKNOWN).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15137737 ↗
• InjuryOct 28, 2021Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 05, 2021 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A BILIARY OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT DID NOT "OPEN" INSIDE THE PATIENT. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX PARTIALLY COVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715258 ↗
• MalfunctionOct 13, 2020Premature Activation; Premature Activation

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-04564 AND 3005099803-2020-04572 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT ANATOMY WAS TIGHT AND WAS ATTEMPTED TO BE DILATED USING A HURRICANE BALLOON PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ADVANCING THE STENT THROUGH THE SCOPE, THE WALLFLEX BILIARY RX PARTIALLY COVERED STENT (THE SUBJECT OF THIS REPORT) DEPLOYED PREMATURELY INSIDE THE SCOPE WITHOUT MANIPULATION. THE STENT WAS REMOVED FROM PATIENT WITH THE SCOPE. A SECOND WALLFLEX BILIARY RX PARTIALLY COVERED STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2020-04572) WAS ATTEMPTED TO BE IMPLANTED; HOWEVER, SIMILARLY, THE STENT PREMATURELY DEPLOYED IN THE SCOPE. THE STENT WAS REMOVED FROM THE PATIENT WITH THE SCOPE AND THE PROCEDURE WAS COMPLETED WITH T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10671817 ↗
• MalfunctionOct 13, 2020Premature Activation; Premature Activation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-04564 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020, THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT ANATOMY WAS TIGHT, AND WAS ATTEMPTED TO BE DILATED USING A HURRICANE BALLOON PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ADVANCING THE STENT THROUGH THE SCOPE, THE WALLFLEX BILIARY RX PARTIALLY COVERED STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2020-04564) DEPLOYED PREMATURELY INSIDE THE SCOPE WITHOUT MANIPULATION. THE STENT WAS REMOVED FROM THE PATIENT WITH THE SCOPE. A SECOND WALLFLEX BILIARY RX PARTIALLY COVERED STENT (THE SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE IMPLANTED, HOWEVER, SIMILARLY, THE STENT PREMATURELY DEPLOYED IN THE SCOPE. THE STENT WAS REMOVED FROM THE PATIENT WITH THE SCOPE, AND THE PROCEDURE WAS COMPLETED WITH THE ANOTHER WAL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10671812 ↗
• MalfunctionMar 5, 2020Positioning Failure; Detachment of Device or Device Component; Material Deformation; Material Integrity Problem; Positioning Failure; Detachment of Device or Device Component; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS A PROBLEM FIRING THE WALLFLEX BILIARY MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PHOTOS OF THE COMPLAINT DEVICE WERE RECEIVED AND UPON REVIEW THE OUTER SHEATH WAS DAMAGED AND THE INNER SHAFT WAS KINKED. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHAFT/ SHEATH WAS DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9795340 ↗
• InjuryJul 18, 2019Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2019-03505 AND 3005099803-2019-03506 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2019 THAT TWO WALLFLEX BILIARY RX PARTIALLY COVERED STENTS WERE TO BE USED TO TREAT A PANCREATIC HEAD MASS WHICH BLOCKED THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BOTH WALLFLEX BILARY STENTS WERE ABLE TO BE DEPLOYED. HOWEVER, AFTER THE DELIVERY SYSTEMS WERE REMOVED, THE STENTS MIGRATED OUT OF THE COMMON BILE DUCT. BOTH STENTS WERE REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH A PLASTIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8805109 ↗
• InjuryJul 18, 2019Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2019-03505 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT TWO WALLFLEX BILIARY RX PARTIALLY COVERED STENTS WERE TO BE USED TO TREAT A PANCREATIC HEAD MASS WHICH BLOCKED THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BOTH WALLFLEX BILARY STENTS WERE ABLE TO BE DEPLOYED. HOWEVER, AFTER THE DELIVERY SYSTEMS WERE REMOVED, THE STENTS MIGRATED OUT OF THE COMMON BILE DUCT. BOTH STENTS WERE REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH A PLASTIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8805100 ↗
• MalfunctionApr 22, 2019Positioning 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 PARTIALLY COVERED STENT WAS USED TO BE USED TO TREAT A BILIARY STENOSIS DUE TO A PANCREATIC TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND 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 REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHAFT/ SHEATH WAS DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8537408 ↗
• MalfunctionJan 3, 2019Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DUE TO PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE OUTER SHEATH OF THE CATHETER WOULD NOT UNSHEATHE AND THE STENT WOULD NOT DEPLOY. THE DEVICE WAS REMOVED AND A 10 X 60 WALLFLEX BILIARY FULLY COVERED STENT WAS PLACED 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).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8212881 ↗
• MalfunctionDec 3, 2018Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A 3 CM STRICTURE IN THE BILIARY DUE TO PANCREATIC TUMOR DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT BE RELEASED FROM THE DELIVERY SYSTEM. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT 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 8126054 ↗
• MalfunctionOct 16, 2018Break; Positioning Failure; Difficult to Advance; Break; Positioning Failure; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A 4CM MALIGNANT BILE DUCT MASS 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 THE PROCEDURE, THE GUIDEWIRE HAD A LOT OF TROUBLE EXITING THE RX PORT OF THE DELIVERY SYSTEM. DURING STENT DEPLOYMENT, A LOUD "POP" SOUND WAS HEARD, AND THE STENT WOULD NOT DEPLOY. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN REMOVED FROM THE PATIENT. 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. NOTE: THE EVENT HAS BEEN DEEMED A MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE OUTER SHEATH WAS 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 7969067 ↗
• MalfunctionJul 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED 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 TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS DIFFICULTY EXITING THE GUIDEWIRE AT THE GUIDEWIRE RX PORT. AFTER SEVERAL ATTEMPTS, THE GUIDEWIRE WAS ABLE TO FINALLY PASS THROUGH THE RX PORT. DURING STENT DEPLOYMENT, THE INNER CATHETER BROKE IN HALF INSIDE THE PATIENT, AND THE STENT WAS NOT DEPLOYED. THE WALLFLEX BILIARY DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS NOT COMPLETED. 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 7711704 ↗
• MalfunctionJun 11, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DUE TO PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE SHIPPING MANDREL WAS MANUALLY REMOVED PRIOR TO LOADING THE GUIDEWIRE, AND THEN THE GUIDEWIRE WAS UNABLE TO EXIT AT THE GUIDEWIRE 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'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: ACCORDING TO THE COMPLAINANT, THE SHIPPING MANDREL WAS MANUALLY REMOVED. PER THE WALLFLEX BILIARY RX PARTIALLY COVERED STENT SYSTEM DIRECTIONS FOR USE, ¿BY INSERTING THE TRAILING END OF THE GUIDEWIRE, THE SHIPPING MANDREL WILL BE PUSHED OUT. DO NOT REMOVE THE SHIPPING MANDREL BEFORE LOADING THE GUIDEWIRE.¿ THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE OUTER SHEATH WAS DETACHED/ BROKEN AT THE OUTER DIAM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589203 ↗
• MalfunctionJun 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED IN THE COMMON BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN TRYING TO DEPLOY THE STENT. THE STENT AND DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT, WITH THE STENT FULLY COVERED BY THE OUTER SHEATH. THE WALLFLEX WAS REMOVED IN ONE PIECE BUT IT WAS REPORTED THAT THE INNER CATHETER SEEMED TO BE SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7568673 ↗
• MalfunctionMay 17, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED IN THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTED THAT THE CLEAR OUTER SHEATH JUST ABOVE THE STENT WAS KINKED AND CRUSHED. 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 THE INVESTIGATION RESULTS WHICH REVEALED THAT THE CLEAR OUTER SHEATH WAS BROKEN AT THE GUIDEWIRE ACCESS SHEATH (GAS) SECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7523667 ↗
• MalfunctionMar 2, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE OUTER SHEATH WAS BROKEN AT THE OUTER DIAMETER: PROXIMAL EXTERIOR TUBE ¿ ENDOSCOPE INTERFACE (AT THE PROXIMAL END OF THE GUIDEWIRE ACCESS SHEATH).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7309484 ↗
• MalfunctionJan 16, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WOULD NOT 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 GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE OUTER SHEATH WAS BROKEN AT THE OUTER DIAMETER: PROXIMAL EXTERIOR TUBE: ENDOSCOPE INTERFACE (AT THE PROXIMAL END OF THE GUIDEWIRE ACCESS SHEATH).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7195249 ↗
• MalfunctionJan 12, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS USED TO TREAT A 3 CM MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED TO DEPLOY THE STENT. HOWEVER, DURING STENT DEPLOYMENT, THE PHYSICIAN HEARD A ¿KNACK¿ SOUND AND THE STENT FAILED TO DEPLOY. THE PHYSICIAN REMOVED THE STENT FROM THE PATIENT AND 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 RESULTS WHICH REVEALED THAT THE OUTER SHEATH WAS BROKEN AT THE OUTER DIAMETER: PROXIMAL EXTERIOR TUBE (AT THE PROXIMAL END OF THE GUIDEWIRE ACCESS SHEATH).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7186732 ↗