Axios™ M00553670Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08714729979333), received between Aug 31, 2020 and May 11, 2026 — classified as 14 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (12 reports).

1 FDA recall record name this device's identifier, 1 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 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-1027-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 11, 2026Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSGASTRIC TO TREAT A PANCREATIC FLUID COLLECTION (PFC) DURING A PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE FIRST FLANGE DID NOT DEPLOY. THE PHYSICIAN TRIED TO REPOSITION THE SCOPE TO HELP RELEASE THE FLANGE BUT EVENTUALLY DECIDED TO REMOVE THE DEVICE. THE PROCEDURE WAS ABLE TO BE COMPLETED BY 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 25144884 ↗
• MalfunctionMay 11, 2026Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO PANCREAS TO TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY DEPLOYING THE STENT. PRIOR TO DEPLOYMENT, THE TECHNICIAN OVER-TIGHTENED THE LOCKING MECHANISM TO THE SCOPE, AND A LOW BUT AUDIBLE CRACKING SOUND WAS HEARD. THE BLACK LOCKING MECHANISM AND THE GREY HANDLE WERE OVERTURNED SIMULTANEOUSLY. UPON THE SECOND STEP OF DEPLOYMENT, DURING RELEASE OF THE DISTAL AXIOS FLANGE, THE PHYSICIAN REPORTED NO TENSION WHILE MOVING THE #2 HUB. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A DIFFERENT AXIOS STENT (20 MM X 10 MM). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144382 ↗
• InjuryMar 25, 2026Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSGASTRIC TO TREAT A PANCREATIC PSEUDOCYST DRAINAGE DURING ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026 DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE FIRST AND SECOND FLANGE SUCCESSFULLY DEPLOYED BUT NOTICED THAT THE FIRST FLANGE DID NOT FULLY OPEN ALL THE WAY. THERE WAS NO RESISTANCE WHEN DEPLOYING THE FIRST FLANGE. THE SCOPE POSITION WAS NORMAL WITHOUT TORQUE. THE ELEVATOR WAS NOT ENGAGED, AND THE PHYSICIAN PULLED THE AXIS, STAND OUT AND CLOSED THE FISTULA WITH AN OVESCOCLIP. 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 24690911 ↗
• MalfunctionFeb 20, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED FOR PSEUDOCYST DRAINAGE DURING A CYST GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE AXIOS STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, RESISTANCE WAS ENCOUNTERED WHEN THE CATHETER WAS REMOVED FROM THE PATIENT BECAUSE THE NOSE CONE BECAME CAUGHT ON THE ELEVATOR, CAUSING THE CATHETER TO BREAK OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24407000 ↗
• MalfunctionJul 3, 2025Entrapment of Device; Positioning Problem; Entrapment of Device; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, UNDER FLUOROSCOPIC GUIDANCE, THE DISTAL FLANGE WAS DEPLOYED INTO THE STOMACH AND WAS INADVERTENTLY REATTACHED TO THE ENDOSCOPE AND PROXIMAL FLANGE BECAME LODGED WITHIN THE SCOPE'S CHANNEL. THERE WERE PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401103 ↗
• MalfunctionJul 1, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON MAY 28, 2025. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY PENETRATING THE STOMACH WALL. INSTEAD OF A CLEAN CUT, THE DEVICE PRODUCED A BURN EFFECT, REQUIRING THREE PUNCTURE ATTEMPTS TO ACHIEVE ACCESS. ON THE THIRD ATTEMPT, THE SETTINGS ON THE GENERATOR WERE ADJUSTED, WHICH FACILITATED SUCCESSFUL ENTRY. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374043 ↗
• InjuryJun 26, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS WAS IMPLANTED IN THE PANCREAS TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE AXIOS STENT DEPLOYED INCORRECTLY INTO THE PSEUDOCYST. THE DEVICE WAS APPARENTLY LEFT IMPLANTED, AND THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATIVE METHOD. HOWEVER, THE AXIOS STENT IS SCHEDULED TO BE EXPLANTED ON (B)(6) 2025. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338989 ↗
• InjuryMay 6, 2025Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE JEJUNUM TO TREAT A GASTRIC OUTLET OBSTRUCTION (PYLORIC STENOSIS) DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED, BUT THE DISTAL FLANGE OF THE STENT DID NOT OPEN. THE PHYSICIAN ADJUSTED THE CATHETER AND THE POSITION OF THE SCOPE, AND THE STENT EVENTUALLY FULLY DEPLOYED; HOWEVER, IT DEPLOYED IN THE STOMACH AND NOT ACROSS THE STRICTURE. THE STENT WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT SIZE AXIOS STENT. 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 A GASTRIC OUTLET OBSTRUCTION (PYLORIC STENOSIS). 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 SI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973102 ↗
• InjuryMay 6, 2025Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE JEJUNUM TO TREAT A GASTRIC OUTLET OBSTRUCTION (PYLORIC STENOSIS) DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED, BUT THE DISTAL FLANGE OF THE STENT DID NOT OPEN. THE PHYSICIAN ADJUSTED THE CATHETER AND THE POSITION OF THE SCOPE, AND THE STENT EVENTUALLY FULLY DEPLOYED; HOWEVER, IT DEPLOYED IN THE STOMACH AND NOT ACROSS THE STRICTURE. THE STENT WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT SIZE AXIOS STENT. 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 A GASTRIC OUTLET OBSTRUCTION (PYLORIC STENOSIS). 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 SI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973085 ↗
• InjuryNov 8, 2024Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO GALLBLADDER TO TREAT A COPIOUS HETEROGENOUS DEBRIS DURING A GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED COVERED WITH THE OUTER SHEATH AND A SECOND STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED TRANSGASTRIC TO GALLBLADDER. HOWEVER, PER AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), "THE AXIOS STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYST GREATER THAN OR EQUAL TO 6CM IN SIZE AND WALLED-OFF NECROSIS GREATER THAN OR EQUAL TO 6CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL". THE PHYSICIAN DID NOT FOLLOW THE LABELED INDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20643468 ↗
• MalfunctionJul 2, 2024Use of Device Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE GALLBLADDER TO TREAT A CHOLELITHIASIS DURING A GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN FELT THAT THE CATHETER SNAPPED WHEN THE STENT DEPLOYMENT HUB WAS PULLED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS IMPLANTED TRANSGASTRIC TO THE GALLBLADDER DURING A GALLBLADDER DRAINAGE PROCEDURE. 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 AND WALLED-OFF NECROSIS >= 6 CM IN SIZE WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED FOR PLACEMENT TRANSGASTRIC TO THE GALLBLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659331 ↗
• InjuryFeb 14, 2024Break; Positioning Failure; Off-Label Use; Defective Device; Break; Positioning Failure; Off-Label Use; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE GASTRIC POUCH TO THE EXCLUDED STOMACH DURING AN ENDOSCOPIC ULTRASOUND DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT FIRST FLANGE, HOWEVER, THE STENT DID NOT DEPLOY. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH 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 18704652 ↗
• InjuryNov 17, 2023Use 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 TRANSGASTRIC TO THE JEJUNUM FOR THE TREATMENT OF PANCREATIC HEAD MASS DURING A GASTROJEJUNOSTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WAS DIFFICULTY ENCOUNTERED WHEN DEPLOYING THE STENT. THE STENT EVENTUALLY FULLY DEPLOYED; HOWEVER, THE FIRST FLANGE DID NOT EXPAND WHICH RESULTED TO THE STENT MOVING OUT OF ITS POSITION. THE STENT WAS CLIPPED ON EACH SIDE TO MARK THE LOCATION OF THE PUNCTURE. THE STENT WAS THEN REMOVED AND THE PUNCTURE SITE WAS CLOSED USING RESOLUTION CLIPS. ANOTHER AXIOS STENT WAS IMPLANTED 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 DURING A GASTROJEJUNOSTOMY PROCEDURE. 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 AND WALLED-OFF NECROSIS >= 6 CM IN SIZE WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160035 ↗
• InjuryOct 25, 2023Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2023-05657 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENTS AND AN ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE TO BE IMPLANTED TRANSGASTRICALLY INTO THE GALLBLADDER TO TREAT A GALLBLADDER INFECTION DURING A GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE FIRST AXIOS STENT'S FIRST FLANGE (THE SUBJECT OF MFR. REPORT 3005099803-2023-05657) WAS ATTEMPTED TO BE DEPLOYED, THE GRAY STENT DEPLOYMENT HUB WAS DIFFICULT TO PULL UP AND IT BROKE AND FELL OFF OF THE HANDLE. AN ATTEMPT WAS MADE TO DEPLOY THE STENT'S SECOND FLANGE USING HEMOSTAT GRASPERS, BUT IT WAS UNSUCCESSFUL, SO THE STENT REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. A SECOND AXIOS STENT (THE SUBJECT OF THIS REPORT) WAS OPENED, BUT IT WAS NOT ABLE TO ADVANCE THROUGH THE PATIENT'S ANATOMY. THE PUNCTURE SITE WAS THEN CLOSED USING CLIPS, AND THE PROCEDURE WAS NOT COMPLETED. THE PATIENT EXPERIENCED BILE AND PUS LEAKAGE AT THE PUNCTURE SITE INTO THE PERITONEAL CAVITY, SO THE PHYSICIAN ADMINI

  Patient problems: Biliary Leak; Purulent Discharge

  MAUDE report 18002318 ↗
• MalfunctionOct 13, 2023Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE USED IN THE PANCREAS DURING A PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, IT WAS NOTED THAT THE OUTER PACKAGING WAS DAMAGED, AND THE INNER STERILE PACKAGING SEAL WAS COMPROMISED. ANOTHER AXIOS 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 17930902 ↗
• InjuryOct 10, 2023Use of Device Problem; Positioning Problem; Activation Failure; Use of Device Problem; Positioning Problem; Activation Failure

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT#: 3005099803-2023-05438 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS USED IN THE EFFERENT LIMB TO TREAT A "CANDY CANE SYNDROME" DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE AXIOS STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED; HOWEVER, THE STENT'S FIRST FLANGE WAS UNABLE TO EXPAND WHICH RESULTED IN THE STENT MOVING OUT OF ITS POSITION. A SECOND AXIOS STENT (THE SUBJECT OF MFR. REPORT#: 3005099803-2023-05438) WAS USED BUT THE SAME PROBLEM OCCURRED. BOTH STENTS WERE REMOVED USING RAT-TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH A 15MM X 10MM AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS TO BE IMPLANTED IN THE EFFERENT LIMB TO TREAT A CANDY CANE SYNDROME. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL END

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906420 ↗
• InjuryOct 10, 2023Use of Device Problem; Positioning Problem; Activation Failure; Use of Device Problem; Positioning Problem; Activation Failure

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2023-05437 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS USED IN THE EFFERENT LIMB TO TREAT A "CANDY CANE SYNDROME" DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE AXIOS STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-05437) WAS DEPLOYED; HOWEVER, THE STENT'S FIRST FLANGE WAS UNABLE TO EXPAND WHICH RESULTED IN THE STENT MOVING OUT OF ITS POSITION. A SECOND AXIOS STENT (THE SUBJECT OF THIS REPORT) WAS USED BUT THE SAME PROBLEM OCCURRED. BOTH STENTS WERE REMOVED USING RAT-TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH A 15MM X 10MM AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS TO BE IMPLANTED IN THE EFFERENT LIMB TO TREAT A CANDY CANE SYNDROME. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL END

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906320 ↗
• MalfunctionOct 5, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE USED TO TREAT A PSEUDOCYST IN THE PANCREAS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTED THAT THE INNER STERILE PACKAGING SEAL "LOOKED COMPROMISED". ANOTHER AXIOS 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 15543156 ↗
• MalfunctionAug 10, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 22, 2022 THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE PANCREAS FOR PSEUDOCYST DRAINAGE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SECOND FLANGE OF THE AXIOS STENT COULD NOT BE DEPLOYED. THE AXIOS STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND ANOTHER AXIOS STENT WAS IMPLANTED 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 15201174 ↗
• InjuryJun 2, 2022Break; Use of Device Problem; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Difficult to Advance; Break; Use of Device Problem; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE STOMACH DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT HAD A GASTRIC BYPASS SURGERY AND THE AXIOS WAS INTENDED TO BE USED TO BRIDGE THE TWO PARTS OF THE STOMACH TO ALLOW FOR AN ERCP TO BE PERFORMED THROUGH THE AXIOS STENT. DURING THE PROCEDURE, THE GRAY PART OF THE HANDLE WAS DETACHED FROM THE DELIVERY SYSTEM, THE STENT COULD NOT ADVANCE OUT OF THE SCOPE, AND THE STENT WAS UNABLE TO FULLY DEPLOY. THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE HOT AXIOS STENT WAS BEING IMPLANTED TRANSGASTRIC TO THE STOMACH DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE. HOWEVER, PER THE HOT AXIOS STENT AND DELIVERY SYSTEM DIRECTIONS FOR USE (DFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14572798 ↗
• MalfunctionMay 20, 2022Premature Activation; Use of Device Problem; Device-Device Incompatibility; Difficult to Advance; Premature Activation; Use of Device Problem; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT A 1.5 CM TO 2 CM BENIGN STRICTURE PROXIMAL TO THE PYLORUS DURING AN AXIOS STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A GUIDEWIRE WAS USED TO HELP DILATE PATIENT'S ESOPHAGUS AND TO HELP POSITION THE AXIOS STENT. WHILE ADVANCING THE AXIOS STENT OVER THE WIRE, IT STRIPPED THE JACKET OFF THE GUIDEWIRE AND THE FIRST FLANGE OF THE AXIOS STENT DEPLOYED PREMATURELY. THE GUIDEWIRE WAS REMOVED AND WAS REPLACED IN AN ATTEMPT TO RECAPTURE THE STENT, BUT THE AXIOS STENT COULD NOT BE FULLY RECAPTURED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND A METAL STENT WAS SUCCESSFULLY IMPLANTED TO DILATE THE ESOPHAGUS. THE AXIOS PLACEMENT PROCEDURE WAS CANCELLED AND WILL RESUME IN 3 TO 4 WEEKS, UNTIL THE ESOPHAGUS' LUMEN IS WIDE ENOUGH TO ALLOW FOR A THERAPEUTIC SCOPE TO MAKE ITS WAY DOWN TO THE PYLORUS TO PLACE THE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR A BENIGN PYLORIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459127 ↗
• MalfunctionFeb 8, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SECOND FLANGE COULD NOT BE DEPLOYED. THE STENT WAS REMOVED PARTIALLY DEPLOYED FROM THE PATIENT AND 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 13480376 ↗
• InjuryAug 11, 2021Difficult or Delayed Positioning; Use of Device Problem; Mechanical Jam; Positioning Problem; Difficult or Delayed Positioning; Use of Device Problem; Mechanical Jam; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 21, 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TO TREAT AN ANASTOMOTIC STRICTURE DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE FIRST FLANGE WAS DEPLOYED SUCCESSFULLY; HOWEVER, DURING ATTEMPTED DEPLOYMENT OF THE SECOND FLANGE, THERE WAS DIFFICULTY UNLOCKING THE STENT LOCK. THE STENT EVENTUALLY FULLY DEPLOYED BUT IN AN INCORRECT LOCATION. THE STENT WAS REMOVED USING A BIOPSY FORCEPS AND THE PATIENT WAS RESCHEDULED TO COMPLETE THE PROCEDURE ON (B)(6) 2021. 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 TO TREAT AN ANASTOMOTIC 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 AND WALLED-OFF NECROSIS >= 6 CM IN SIZE WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE HOT AXIOS STENT IS NOT INDICATED TO BE IMPLANTED FOR ANASTOMOTIC STRICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310044 ↗
• InjuryNov 5, 2020Difficult 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 OCTOBER 13, 2020 THAT A HOT AXIOS STENT WAS IMPLANTED TO TREAT A PSEUDOCYST IN THE PANCREAS DURING AN ENDOSCOPIC ULTRASOUND (EUS) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE PHYSICIAN THINKS THE TIP OF THE CATHETER WAS DETACHED INSIDE THE PATIENT. REPORTEDLY, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE FROM THE SCOPE AFTER PLACEMENT OF THE STENT. THE STENT REMAINS IMPLANTED AND THE TIP WILL BE REMOVED DURING THE SCHEDULED REMOVAL OF THE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791311 ↗
• InjuryAug 31, 2020Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TO TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) GUIDED DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COMPLETELY CAME OFF THE DELIVERY SYSTEM WHEN THE FIRST FLANGE WAS ATTEMPTED TO BE DEPLOYED. THE FULLY DEPLOYED STENT WAS REMOVED AND ANOTHER AXIOS STENT 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 10472387 ↗