Axios™ M00553680Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00191506008086), received between Oct 5, 2021 and Mar 30, 2026 — classified as 7 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (10 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Dec 19, 2025Open, Classified

   Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

   Z-1159-2026 · Root cause: Process control · FDA record ↗

2. Dec 20, 2024Open, Classified

   Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

   Z-1028-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE COMMON BILE DUCT (CBD) TO FACILITATE DRAINAGE DURING A ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, UPON ATTEMPTING TO DEPLOY THE SECOND FLANGE OF THE AXIOS IN THE TARGET SITE, IT DID NOT DEPLOY. THE PHYSICIAN IDENTIFIED THE ISSUE, LEFT WIRE IN CBD AND USED ANOTHER AXIOS TO SUCCESSFULLY IMPLANT THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING AND USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED DURING A CHOLEDOCHODUODENOSTOMY PROCEDURE. HOWEVER, ACCORDING TO THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS 6 CM OR LARGER IN SIZE AND WALLED-OFF NECROSIS 6 CM OR LARGER IN SIZE WITH AT LEAST 70% FLUID CONTENT, PROVIDED THEY ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714446 ↗
• MalfunctionJan 13, 2026Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE PANCREAS TO FACILITATE A PSEUDOCYST DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DISTAL FLANGE DID NOT OPEN, IT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED BY REPLACING AND USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058182 ↗
• MalfunctionDec 11, 2025Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE BILE DUCT TO FACILITATE DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST FLANGE, BUT IT DID NOT FULLY OPEN. ALTHOUGH THE INITIAL STEPS (1 AND 2) WERE COMPLETED, THE DISTAL FLANGE FAILED TO OPEN. THE PROCEDURE WAS COMPLETED BY REPLACING AND USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783432 ↗
• MalfunctionOct 21, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND ENDOSCOPIC ULTRASOUND (ERCP AND EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY PROPERLY. THE PROCEDURE WAS COMPLETED BY REPLACING AND USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347805 ↗
• InjurySep 24, 2025Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE BILE DUCT TO FACILITATE A BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN HAD ISSUES DEPLOYING THE SECOND FLANGE, AS IT DID NOT OPEN PROPERLY WHILE IN SCOPE POSITION, RESULTING IN UNSUCCESSFUL DEPLOYMENT. AN ATTEMPT WAS MADE TO PLACE THE STENT AGAIN, BUT IT WAS ULTIMATELY REMOVED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED BY REPLACING AND USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED IN THE BILE DUCT TO FACILITATE A BILIARY DRAINAGE. HOWEVER, ACCORDING TO THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANS GASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS 6 CM OR LARGER IN SIZE AND WALLED-OFF NECROSIS 6 CM OR LARGER IN SIZE WITH AT LEAST 70% FLUID CONTENT, PROVIDED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23132053 ↗
• InjurySep 11, 2025Use of Device Problem; Difficult to Advance; Positioning Problem; Activation Failure; Poor Visibility; Use of Device Problem; Difficult to Advance; Positioning Problem; Activation Failure; Poor Visibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TO DRAIN THE BILE DUCT DURING AN ENDOSCOPIC ULTRASOUND (EUS) CHOLEDOCHODUODENOSTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE ACCESS SITE WAS SMALL, AND THE GUIDEWIRE COULD NOT BE ADVANCED PROXIMALLY. THE INITIAL PUNCTURE WAS SUCCESSFUL; HOWEVER, THE IMAGE WAS UNCLEAR, AND FLANGE OPENING COULD NOT BE CONFIRMED. UPON TENTING, THE PHYSICIAN FELT THE DEVICE WAS SECURED. WHILE DEPLOYING THE EXTERNAL FLANGE, THE INTERNAL FLANGE WAS INADVERTENTLY PULLED THROUGH INTO THE SMALL BOWEL. THE PHYSICIAN SALVAGED THE DRAINAGE BY DEPLOYING A FULLY COVERED WALLFLEX STENT THROUGH THE AXIOS TRACT INTO THE DUCT AND PLACING A DOUBLE PIGTAIL STENT THROUGH IT. THEREFORE, THE PROCEDURE WAS COMPLETED USING THE AXIOS STENT, ASSISTED BY ADDITIONAL DIFFERENT DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED DURING AN ENDOSCOPIC ULTRASOUND (EUS) CHOLEDOCHODUODENOSTOMY PROCEDURE. HOWEVER, ACCORDING TO THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031568 ↗
• InjuryAug 13, 2025Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED INTO THE PANCREAS FOR A PSEUDOCYST DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT SECOND FLANGE DID NOT OPEN PROPERLY. WHEN ATTEMPTING TO REMOVE THE STENT AND DISCONNECT THE GENERATOR CORD, THE PIN DETACHED FROM THE AXIOS HANDLE, REQUIRING THE USE OF A HEMOSTAT FOR REMOVAL. THE PROCEDURE WAS COMPLETED BY REPLACING AND USING 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 22800253 ↗
• MalfunctionJul 23, 2025Use of Device Problem; Positioning Problem; Activation Failure; Use of Device Problem; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A PANCREATIC HEAD MASS, WHICH CREATED AN OBSTRUCTION IN THE DUODENUM, DURING A CHOLEDOCHODUODENOSTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE AXIOS STENT FIRST FLANGE DID NOT OPEN. THE PHYSICIAN PROCEEDED TO STEPS 3 AND 4, WHICH WERE COMPLETED SUCCESSFULLY. HOWEVER, IN THE PHYSICIAN'S ASSESSMENT, THE PLACEMENT OF THE AXIOS STENT WAS NOT IDEAL, AS THE DISTAL FLANGE WAS SLIGHTLY IN THE DUODENUM AND THERE WAS A CONCERN THAT IT MIGHT HAVE BEEN IN THE PERITONEAL SPACE, NOT FULLY IN THE COMMON BILE DUCT. A CANNULA WAS USED TO CANNULATE THE STENT, AND A WIRE WAS PASSED THROUGH THE STENT WITH THE INTENTION TO PLACE A DOUBLE PIG-TAIL PLASTIC STENT TO MAINTAIN ACCESS. BILE WAS OBSERVED DRAINING FROM THE AXIOS STENT, AND THE PHYSICIAN CONCLUDED THAT THE DISTAL FLANGE WAS IN THE COMMON BILE DUCT AND NOT IN THE PERITONEAL SPACE. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS IMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22581179 ↗
• MalfunctionJan 9, 2025Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT A CYST DURING A CYSTOGASTRONOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE AXIOS STENT WOULD NOT DEPLOY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT STENT WAS PARTIALLY DEPLOYED. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114448 ↗
• MalfunctionDec 2, 2024Difficult to Remove; Use of Device Problem; Difficult or Delayed Activation; Difficult to Remove; Use of Device Problem; Difficult or Delayed Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE COMMON BILE DUCT FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY, BUT IT TOOK A WHILE TO EXPAND, MAKING REMOVAL OF THE DELIVERY SYSTEM DIFFICULT. THE PHYSICIAN WAITED FOR APPROXIMATELY 30 SECONDS BEFORE THE STENT EVENTUALLY EXPANDED AND THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR BILIARY DRAINAGE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE, THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL AND ARE FREE OF SOLID DEBRIS. THE DEVICE IS NOT INDICATED TO BE PLACED IN THE COMMON BILE DUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819713 ↗
• InjuryMar 29, 2024Break; Use of Device Problem; Activation Failure; Break; Use of Device Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE BILE DUCT TO TREAT A BILE DUCT OBSTRUCTION DUE TO PANCREATIC CANCER DURING A CHOLEDOCODUODOSTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE FIRST FLANGE WAS DEPLOYED; HOWEVER, IT DID NOT EXPAND. THE PHYSICIAN ATTEMPTED TO RECAPTURE THE STENT, BUT THE HANDLE BROKE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT A BILE DUCT OBSTRUCTION. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE, THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL AND ARE FREE OF SOLID DEBRIS. THE DEVICE IS NOT INDICATED TO BE PLACED IN THE BILE DUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19007012 ↗
• MalfunctionNov 2, 2023Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE PANCREAS FOR THE TREATMENT OF PANCREATITIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED DESPITE SEVERAL ATTEMPTS. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058103 ↗
• MalfunctionJun 8, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE PANCREAS TO TREAT A PANCREATIC FLUID COLLECTION DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE AXIOS CAUTERY DID NOT WORK, AND A LITTLE BLANCHING OF THE TISSUE WAS NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17091972 ↗
• InjuryMay 11, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE BILE DUCT FOR THE TREATMENT OF PANCREATIC CANCER AND MALIGNANT BILIARY OBSTRUCTION DURING AN ENDOSCOPIC ULTRASOUND (EUS)- GUIDED CHOLEDOCHODUODENOSTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE PHYSICIAN ATTEMPTED TO SHAKE AND WIGGLE THE CATHETER; HOWEVER, THE STENT COULD STILL NOT BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND A NON-BOSTON SCIENTIFIC DEVICE 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 16916837 ↗
• InjuryMay 8, 2023Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 18, 2023, THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE BILE DUCT TO TREAT A BILIARY STRICTURE DURING A BILIARY ACCESS PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH AND THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY (IR) TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TRANSDUODENAL TO THE BILE DUCT TO TREAT A BILIARY STRICTURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE, THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL AND ARE FREE OF SOLID DEBRIS. THE DEVICE IS NOT INDICATED TO BE PLACED IN THE BILE DUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886906 ↗
• MalfunctionMar 21, 2023Failure to Conduct; Failure to Conduct

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A 6CM CYST DURING A PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE AXIOS CAUTERY DID NOT WORK. THERE WAS NO BLANCHING OF THE TISSUE. THE PROCEDURE WAS ABORTED AND THE PATIENT WILL BE RESCHEDULED FOR ANOTHER PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588239 ↗
• InjuryNov 21, 2022Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A COMMON BILE DUCT OBSTRUCTION DURING A CHOLEDOCHODUODENOSTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE STENT FIRST FLANGE WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE FLANGE WAS NOT VISIBLE UNDER FLUOROSCOPY OR EUS. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE SECOND FLANGE AND COMPLETED STEP "4" OF DEPLOYMENT; HOWEVER, IT WAS NOTED THAT ONLY THE FIRST FLANGE WAS DEPLOYED BUT IT DEPLOYED INSIDE THE DUODENUM. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR A CHOLEDOCHODUODENOSTOMY PROCEDURE TO TREAT A CBD OBSTRUCTION. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE, THAT ARE ADHERENT TO THE GAST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833222 ↗
• MalfunctionOct 5, 2022Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2022 THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A BILIARY OBSTRUCTION CAUSED BY PANCREATIC CANCER DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, THE FIRST FLANGE OF THE AXIOS STENT WAS ATTEMPTED TO BE DEPLOYED INTO THE COMMON BILE DUCT; HOWEVER, THE FIRST FLANGE DEPLOYED IN AN INCORRECT LOCATION AND WAS PLACED IN THE DUODENUM. THE AXIOS STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED IN THE COMMON BILE DUCT TO TREAT A BILIARY OBSTRUCTION. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE, THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL AND ARE FREE OF SOLID DEBRIS. THE AXIOS STENT IS NOT INDICATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15542250 ↗
• MalfunctionOct 26, 2021Entrapment of Device; Positioning Problem; Entrapment of Device; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 06, 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2021. THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, THE SECOND FLANGE DID NOT RELEASE FROM THE SCOPE. THE PARTIALLY DEPLOYED STENT WAS REMOVED TOGETHER WITH THE SCOPE AND THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701008 ↗
• MalfunctionOct 5, 2021Entrapment of Device; Use of Device Problem; Positioning Problem; Entrapment of Device; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2021. THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, THE SECOND FLANGE DID NOT RELEASE FROM THE SCOPE. THE PARTIALLY DEPLOYED STENT WAS REMOVED TOGETHER WITH THE SCOPE. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS 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: IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. THE HOT AXIOS STENT AND DELIVERY SYSTEM DIRECTIONS FOR USE STATE, "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576305 ↗