WALLSTENT™ BILIARY H965430600Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08714729204688), received between May 11, 2017 and Apr 17, 2026 — classified as 7 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Nonstandard Device; Material Puncture/Hole; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE SECONDARY TO CHOLANGITIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STAINLESS-STEEL TUBE DETACHED WHILE THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR-REPORTABLE BASED ON INVESTIGATION FINDINGS INDICATING THAT THE INNER SHEATH WAS DETACHED AND THE STENT WIRE PUNCTURED THE CLEAR OUTER SHEATH. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907115 ↗
• MalfunctionDec 12, 2024Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WIRE WAS POPPING OUT OF THE SHEATH AND SEEMED TO BE BROKEN. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE WAS PROVIDED BY THE COMPLAINANT, AND IT WAS NOTED THAT THE STENT WIRE PUNCTURED THE OUTER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920570 ↗
• MalfunctionSep 20, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS USED TO TREAT A CHOLANGIOCARCINOMA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY AND WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT A LATER TIME WITH ANOTHER WALLSTENT BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785504 ↗
• MalfunctionApr 12, 2022Material Puncture/Hole; Failure to Advance; Material Integrity Problem; Material Puncture/Hole; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE BILE DUCT DURING A BILIARY STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE OUTER SHEATH WAS DAMAGED AND THE STENT DELIVERY SYSTEM WAS UNABLE TO CROSS THE STRICTURE. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY. 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. THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WIRE PUNCTURED THE CLEAR OUTER SHEATH OF THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14088631 ↗
• MalfunctionFeb 8, 2022Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BLIARY UNCOVERED STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT JAUNDICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BLIARY 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 TIP WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483458 ↗
• MalfunctionNov 30, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT AN OBSTRUCTIVE JAUNDICE-HILAR CHOLANGIOCARCINOMA IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED INSIDE THE PATIENT. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, THE STENT GOT CAUGHT ON THE DELIVERY SYSTEM. THE STENT WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT 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 12891978 ↗
• MalfunctionJul 13, 2021Break; Material Puncture/Hole; Break; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A 4CM MALIGNANT STRICTURE IN THE MIDDLE OF THE COMMON BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE HANDLE GOT DETACHED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WIRE PUNCTURED THE CLEAR OUTER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159417 ↗
• InjuryJul 12, 2021Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLSTENT BILIARY STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING A STENTING 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 DID NOT RELEASE AND THE WHITE OLIVE TIP DETACHED INSIDE THE PATIENT. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH AND THE DETACHED TIP WAS REMOVED FROM THE PATIENT USING A STONE RETRIEVAL BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12149834 ↗
• MalfunctionMar 22, 2021Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY STENT WAS TO BE IMPLANTED TO TREAT A 4 CM MALIGNANT STENOSIS IN THE BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY 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. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WIRE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541559 ↗
• MalfunctionMar 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021, THAT A WALLSTENT BLIARY UNCOVERED STENT WAS TO BE IMPLANTED. TO TREAT A 5CM MALIGNANT STRICTURE IN THE COMMON BILE DUCT, DURING A BILIARY STENTING PROCEDURE. PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS. AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE DEVICE BOX WAS OPENED AND THE WHITE OLIVE TIP WAS FOUND DETACHED FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497697 ↗
• InjuryFeb 17, 2021Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 28, 2021 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS IMPLANTED TO TREAT A LARGE PERIAMPULLARY CARCINOMA IN THE AMPULLA 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, A ROUTINE FOLLOW UP WAS PERFORMED ON (B)(6) 2020. DURING THE OESOPHAGO-GASTRO DEUODENOSCOPY (OGD) PROCEDURE, IT WAS NOTED THAT THE STENT MIGRATED PROXIMALLY INTO THE COMMON BILE DUCT. REPORTEDLY, THE STENT REMAINS IMPLANTED AND THE PHYSICIAN IS COMFORTABLE LEAVING THE STENT IN PLACE. HOWEVER, A DIFFERENT DEVICE 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 11340251 ↗
• MalfunctionSep 10, 2020Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS IMPLANTED TO TREAT A 4 CM MALIGNANT STRICTURE IN THE MID COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT DID NOT OPEN IN THE COMMON BILE DUCT. THE DOCTOR PULLED OUT THE CATHETER AND AGAIN PASSED AND TRIED TO DEPLOY THE STENT AND SUDDENLY, THE STENT PREMATURELY DEPLOYED INSIDE THE PATIENT. REPORTEDLY, THE STENT REMAINS IMPLANTED AND THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACE. ANOTHER WALLSTENT 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 Consequences Or Impact To Patient

  MAUDE report 10513671 ↗
• MalfunctionAug 24, 2020Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 03, 2020 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS USED TO TREAT A MALIGNANT STENOSIS IN THE COMMON HEPATIC DUCT DURING A PERCUTANEOUS DRAINAGE WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. REPORTEDLY, IT WAS NOTED THAT THE TIP OF THE DELIVERY SYSTEM WAS DAMAGED OR BROKEN DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT 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 10444693 ↗
• MalfunctionApr 29, 2020Positioning Failure; Material Puncture/Hole; Detachment of Device or Device Component; Positioning Failure; Material Puncture/Hole; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY AND THE BLUE OUTER SHEATH WAS DETACHED FROM THE VALVE BODY. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH AND ANOTHER WALLSTENT BILIARY STENT WAS PLACED 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: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WIRE PUNCTURED THE CLEAR OUTER SHEATH OF THE DELIVERY SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10011536 ↗
• MalfunctionOct 21, 2019Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A BILE DUCT STRICTURE IN THE HILAR REGION DURING A METAL STENTING PROCEDURE PERFORMED ON (B)(6), 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS. 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 A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO CANCER AND NOT RELATED TO THE STENT PLACEMENT PROCEDURE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT SOME OF THE STENT WIRES WERE KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215974 ↗
• MalfunctionJun 17, 2019Positioning Failure; Material Puncture/Hole; Positioning Failure; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 24, 2019 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED IN THE HEPATIC DUCT TO TREAT A MALIGNANT METASTATIC TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. REPORTEDLY, A FEW WIRES OF THE STENT PUNCTURED THROUGH THE OUTER SHEATH. THE PROCEDURE WAS COMPLETE WITH ANOTHER WALLSTENT BILIARY DEVICE. 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 8705572 ↗
• MalfunctionApr 3, 2019Material Puncture/Hole; Failure to Advance; Activation, Positioning or Separation Problem; Material Puncture/Hole; Failure to Advance; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DUE TO BILIARY CANCER DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WALLSTENT WAS UNABLE TO CROSS THE STRICTURE. REPORTEDLY, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT WAS NOT FULLY RELEASED. THE DEVICE WAS REMOVED FROM THE PATIENT PARTIALLY COVERED WITH THE OUTER SHEATH. THE PHYSICIAN NOTED THAT THE STENT WIRE PERFORATED AND WAS COMING OUT OF THE OUTER SHEATH OF THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480413 ↗
• MalfunctionAug 21, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED IN THE BILE DUCT DURING A PERCUTANEOUS TRANSHEPATIC CHOANGIOGRAPHY AND BILIARY DRAINAGE (PTCD) WITH STENTING PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, THE STENT WAS TESTED FOR ITS DEPLOYMENT MECHANISM. APPARENTLY, THE STENT FAILED TO DEPLOY; IT WOULD NOT OPEN UP SMOOTHLY AND HIGH RESISTANCE WAS ENCOUNTERED DURING DEPLOYMENT. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS 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 UNCROSSED WIRES AND KINKED WIRES AT THE TWO ENDS OF THE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7802950 ↗
• InjuryAug 9, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A BILIARY OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT MIGRATED IMMEDIATELY AFTER DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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. 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 Consequences Or Impact To Patient

  MAUDE report 7770209 ↗
• MalfunctionAug 2, 2018Material Perforation; Material Perforation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE HILAR REGION OF THE COMMON BILE DUCT DURING A 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 STENT FAILED TO DEPLOY. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN REMOVED FROM THE PATIENT. REPORTEDLY, THE PHYSICIAN TRIED TO DEPLOY THE STENT OUTSIDE THE PATIENT BUT IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY DEVICE. 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. THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WIRE PERFORATE THE OUTER SHEATH AT THE DISTAL SECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7744842 ↗
• MalfunctionJul 12, 2018Material Perforation; Material Perforation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A STRICTURE IN THE MID COMMON BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING STENT DEPLOYMENT, ONE OF THE STENT WIRE CAME OUT AND PERFORATED THE OUTER SHEATH, AND THEN THE STENT WAS NOT RELEASED FROM THE DELIVERY SYSTEM. THE WALLSTENT DEVICE WAS REMOVED FROM THE PATIENT AND A DIFFERENT DEVICE 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 Consequences Or Impact To Patient

  MAUDE report 7683767 ↗
• InjuryJun 13, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE HILAR REGION OF THE COMMON BILE DUCT DURING A 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 STENT DEPLOYMENT, THE STAINLESS STEEL HUB SUDDENLY TWISTED, AND CAUSING 80- 90% OF THE STENT TO BE DEPLOYED OUTSIDE THE PAPILLA. THE STENT WAS REMOVED FROM THE PAPILLA WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT 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 7598096 ↗
• MalfunctionApr 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 27, 2018 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A STRICTURE WITH MID-COMMON BILE DUCT (CBD) BLOCK DUE TO CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TORTUOUS AND WAS DILATED WITH HURRICANE BILIARY DILATOR BALLOON. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS DIFFICULT TO ADVANCE THE STENT THROUGH THE STRICTURE. DEPLOYMENT WAS ATTEMPTED BUT THE STENT WOULD NOT DEPLOY. THE WALLSTENT WAS THEN REMOVED FROM THE PATIENT AND THE ATRAUMATIC TIP DETACHED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. THERE WERE NO 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 7426915 ↗
• MalfunctionApr 12, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A BILIARY STRICTURE CAUSED BY HILAR CHOLANGIOCARCINOMA DURING A PLANNED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED WITH DILATATION BALLOON PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY AND THE INNER SHAFT KINKED OUT OF THE GUIDEWIRE ACCESS SHEATH. THE PROCEDURE WAS NOT COMPLETED AS SAME DEVICE WAS UNAVAILABLE. AN ERCP WAS PERFORMED ON ANOTHER DAY AND A PLASTIC STENT WAS PLACED. 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 STENT HAS UNCROSSED WIRES AT ONE END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7426905 ↗
• InjuryApr 11, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2018 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS DIFFICULTY RECONSTRAINING THE STENT CAUSING THE STENT TO BE DEPLOYED PREMATURELY. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT 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 7421249 ↗