Axios™ M00553750Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729904632), received between Dec 27, 2016 and Jun 25, 2026 — classified as 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (10 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-1031-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Entrapment of Device

  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 PSEUDOCYST DURING A DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE SECOND FLANGE DID NOT DEPLOY OUT OF THE SCOPE. THE PHYSICIAN TRIED TO PLUNGE AND TORQUE SCOPE TO THE RIGHT BUT WAS UNSUCCESSFULLY. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE BY USING ANOTHER AXIOS STENT THROUGH THE INITIAL PUNCTURE SITE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630305 ↗
• MalfunctionMay 15, 2026Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE TRANSGASTRIC TO RETRIEVE A PANCREATIC FLUID COLLECTION DURING A CYSTGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE STENT AFTER UNLOCKING THE BLACK ARROW LOCK SWITCH AND SQUEEZING GREY HANDLE, THE KNOB OF THE DEVICE BROKE INTO TWO PIECES. THE AXIOS WAS UNABLE TO DEPLOY SO THE PHYSICIAN REMOVED THE HANDLE AND STENT. 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. NOTE: IT WAS REPORTED THAT THE PHYSICIAN ROTATED THE ENTIRE HANDLE DURING THE PROCEDURE. PER THE IFU (INSTRUCTIONS FOR USE) ROUTINE ROTATION OF THE AXIOS HANDLE ITSELF IS NOT PART OF STENT DEPLOYMENT OR POSITIONING. ROTATION IS ONLY REFERENCED FOR SPECIFIC LOCKING/UNLOCKING STEPS, NOT FOR ADVANCING, RETRACTING, OR DEPLOYING THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186102 ↗
• MalfunctionMar 17, 2026Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED IN THE PANCREAS TO FACILITATE PANCREATIC FLUID COLLECTION (PFC) DURING A CYSTOGASTROSTOMY PROCEDURE PERFORMED ON (B)(6). REPORTEDLY, THE PHYSICIAN APPROPRIATELY IDENTIFIED THE PFC VIA MEDICAL IMAGING. THE TARGET WAS VISUALIZED AND THE STENT WAS DEPLOYED. AFTER DEPLOYMENT, THE PHYSICIAN SUSPECTED THAT THE STENT MAY HAVE BEEN PLACED INTO THE GALLBLADDER RATHER THAN THE INTENDED PFC. THE STENT WAS REPORTED TO BE CURRENTLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620092 ↗
• InjuryDec 10, 2025Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSGASTRIC TO FACILITATE A PSEUDOCYST DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. REPORTEDLY, 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 DEPLOYED INTO THE STOMACH, BUT THE CONNECTION BETWEEN THE CYST AND THE STOMACH COULD NOT BE COMPLETED. THE STENT WAS THEN REMOVED PARTIALLY DEPLOYED, AND CLIPS WERE PLACED TO CLOSE THE GASTRIC PERFORATION. THE PHYSICIAN DECIDED NOT TO ATTEMPT PLACEMENT OF A SECOND STENT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND PAIN DUE TO THE REPORTED ISSUE. HOWEVER, THE PATIENT WAS SENT HOME. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 23769349 ↗
• InjuryJul 7, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN AXIOS STENT AND DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE INNER COMPONENTS OF THE AXIOS STENT DEPLOYMENT HUB BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE AXIOS STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. HOWEVER, PER THE AXIOS STENT AND 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 TO TREAT A STRICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14950389 ↗
• MalfunctionDec 17, 2021Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 26, 2021 THAT A COLD AXIOS STENT WAS TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A PANCREATIC FLUID COLLECTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN USED A DOUBLE CHANNEL SCOPE AND ATTEMPTED TO DEPLOY THE STENT; HOWEVER, THE STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND THE PROCEDURE WAS COMPLETED USING A METAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT A DOUBLE CHANNEL SCOPE WAS DURING THE PROCEDURE. THE HOT AXIOS STENT AND DELIVERY SYSTEM DIRECTIONS FOR USE STATE THE AXIOS DELIVERY SYSTEM IS COMPATIBLE WITH THERAPEUTIC ECHOENDOSCOPES. THIS DEVICE IS NOT COMPATIBLE WITH A DOUBLE CHANNEL SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025160 ↗
• InjuryMar 4, 2021Use of Device Problem; Detachment of Device or Device Component; Positioning Problem; Use of Device Problem; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 9, 2021 THAT A COLD AXIOS STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE TRANSDUODENAL TO THE SECOND PORTION OF THE DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE HANDLE OF THE AXIOS STENT WAS NOT LOCKED ON THE SCOPE. DURING STENT DEPLOYMENT, THE STENT WAS DEPLOYED DISTALLY AND A PORTION OF THE INNER SHEATH WAS DETACHED FROM THE DELIVERY SYSTEM. GRASPING FORCEPS WERE USED TO REMOVE THE STENT AND THE BROKEN INNER SHEATH INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER COLD AXIOS STENT. DURING A ROUTINE FOLLOW-UP, THE PATIENT REPORTED OF SORE THROAT. IN THE PHYSICIAN'S ASSESSMENT, RETRIEVAL OF THE BROKEN INNER SHEATH COULD HAVE CAUSED IRRITATION ON THE PATIENT'S THROAT. NO INTERVENTIONS TO ADDRESS THE PATIENT'S SORE THROAT WERE REPORTED AND THE PATIENT WAS REPORTED TO BE FULLY RECOVERED. NOTE: IT WAS REPORTED THAT STENT WAS ATTEMPTED TO BE PLACED TO TREAT A STRICTURE IN THE DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. THE AXIOS STENT AND DELIVERY SYSTEM IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC

  Patient problems: Sore Throat

  MAUDE report 11409029 ↗
• MalfunctionNov 24, 2020Break; Use of Device Problem; Activation, Positioning or Separation Problem; Break; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLD AXIOS STENT WAS TO BE IMPLANTED TO TREAT A PERFORATION IN THE PYLORUS DURING A PYLORIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS DEPLOYED. REPORTEDLY, WHEN TRYING TO DEPLOY THE SECOND FLANGE, A LOT OF RESISTANCE WAS FELT AND IT WAS NOTED THAT THE GREY HUB ON THE HANDLE BROKE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND ANOTHER HOT AXIOS 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 GOOD. NOTE: ACCORDING TO THE COMPLAINANT, THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT A PERFORATION IN THE PYLORUS. HOWEVER, PER THE AXIOS STENT AND 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. THE DEVICE IS N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10896275 ↗
• MalfunctionNov 19, 2020Break; Difficult to Remove; Use of Device Problem; Activation, Positioning or Separation Problem; Break; Difficult to Remove; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 28, 2020 THAT A COLD AXIOS STENT WAS TO BE IMPLANTED TO TREAT AN ANASTOMOTIC STRICTURE IN THE PYLORUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS DEPLOYED. REPORTEDLY, WHEN TRYING TO DEPLOY THE SECOND FLANGE, THE CATHETER WAS DIFFICULT TO MOVE AND A LOT OF RESISTANCE WAS FELT. IT WAS NOTED THAT THE CATHETER CONTROL HUB ON THE HANDLE BROKE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND ANOTHER HOT AXIOS 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 FINE. NOTE: ACCORDING TO THE COMPLAINANT, THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT AN ANASTOMOTIC STRICTURE IN THE PYLORUS. HOWEVER, PER THE AXIOS STENT AND 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10867953 ↗
• MalfunctionFeb 27, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT WAS TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE TO TREAT A PANCREATIC PSEUDOCYST PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST FLANGE WAS DEPLOYED HOWEVER IT WAS PULLED OUT OF THE COLLECTION. THE AXIOS WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9766330 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLD AXIOS STENT WAS IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A PANCREATIC WALLED-OFF NECROSIS (WON) DURING AN AXIOS STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019.THE STENT WAS PLACED AS PART OF THE E7116 AXIOS WON DRAINAGE IDE CLINICAL TRIAL. THE PATIENT WAS ENROLLED INTO THE CLINICAL TRIAL ON (B)(6) 2019. THE STENT WAS REMOVED FROM THE PATIENT ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2019, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH NAUSEA AND VOMITING BLOOD. LABS WERE TAKEN AND WERE NOTED TO BE UNREMARKABLE EXCEPT FOR SLIGHTLY LOW HEMOGLOBIN OF 8.6. THE PATIENT WAS TREATED WITH TWO LITERS OF FLUID, PRESCRIBED ZOFRAN, AND DISCHARGED ON THE SAME DAY. ADDITIONALLY, THE PATIENT HAD BEEN TAKING LOVENOX, BUT THIS WAS HALTED ON (B)(6) WHEN THE SYMPTOMS OF VOMITING BLOOD BEGAN. THE PATIENT HAD A FOLLOW UP APPOINTMENT ON (B)(6) 2019, DURING WHICH THE PATIENT'S HEMOGLOBIN LEVEL WAS NOTED TO BE LOW AT 6.3. THE PATIENT WAS ALSO EXPERIENCING VOMITING OF BLOOD, BLOOD IN STOOL, AND FEVER. IN THE PHYSICIAN'S ASSESSMENT, THE ANEMIA WAS LIKELY RELATED TO THE STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2019

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient

  MAUDE report 9297311 ↗
• InjuryMay 23, 2019Difficult or Delayed Positioning; Use of Device Problem; Positioning Problem; Difficult or Delayed Positioning; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLD AXIOS STENT WAS TO BE IMPLANTED TO TREAT A DUODENAL STRICTURE DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "THE DEVICE MISDEPLOYED." REPORTEDLY, THE PHYSICIAN EXPERIENCED A LITTLE BIT OF RESISTANCE DURING THE ATTEMPTED DEPLOYMENT. A SECOND COLD AXIOS STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT DETAILS DESPITE GOOD FAITH EFFORTS THUS FAR. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOTE: THE STENT WAS INTENDED TO BE PLACED TO TREAT A DUODENAL STRICTURE; HOWEVER, THE HOT AXIOS STENT AND DELIVERY SYSTEM IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6CM IN SIZE AND WALLED-OFF NECROSIS >= 6CM IN SIZE WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637760 ↗
• MalfunctionApr 16, 2019Premature Activation; Premature Activation

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TO TREAT A PANCREATIC WALLED-OFF NECROSIS (WON) DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL FLANGE OF THE STENT DEPLOYED PREMATURELY AND WAS NOT FULLY IN THE COLLECTION. THE DEVICE WAS REMOVED FROM THE PATIENT WITH THE STENT STILL PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PHYSICIAN ATTEMPTED TO PLACE A COLD AXIOS STENT, BUT THE SAME ISSUE OCCURRED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8518220 ↗
• InjuryNov 21, 2018Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS SUCCESSFULLY IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A PANCREATIC WALLED-OFF NECROSIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) WITH AXIOS PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE PHYSICIAN WAS PERFORMING A NECROSECTOMY THROUGH THE PREVIOUSLY PLACED AXIOS STENT USING A DOUBLE CHANNEL SCOPE. THE RAT-TOOTH FORCEPS THAT WERE BEING USED TO PERFORM THE NECROSECTOMY GOT CAUGHT ON THE STENT AND CAUSED IT TO DISLODGE. THE STENT WAS REMOVED USING THE SAME RAT-TOOTHED FORCEPS. ANOTHER AXIOS STENT WAS SUCCESSFULLY 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8094499 ↗
• InjuryOct 28, 2018Difficult to Remove; Use of Device Problem; Human-Device Interface Problem; Migration; Difficult to Remove; Use of Device Problem; Human-Device Interface Problem; Migration

  BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT THROUGH A LITERATURE ARTICLE ENTITLED "THE BURIED LUMEN-APPOSING METAL STENT: IS THIS A STENT PROBLEM, A LOCATION PROBLEM, OR BOTH?" WRITTEN BY SHAYAN IRANI AND RICHARD A. KOZAREK. ACCORDING TO THE ARTICLE, A 10MM X 15MM AXIOS STENT WAS IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A PANCREATIC PSEUDOCYST CYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) CYSTGASTROSTOMY WITH LUMEN-APPOSING METAL STENT (LAMS) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. DURING THE STENT PLACEMENT PROCEDURE, AFTER EUS GUIDEWIRE ACCESS AND BALLOON DILATION, THE PATIENT EXPERIENCED BLEEDING. BALLOON TAMPONADE AND HEATER PROBE WERE UNABLE TO RESOLVE THE BLEEDING. THE AXIOS STENT WAS SUCCESSFULLY DEPLOYED TRANSGASTRIC FROM THE GASTRIC ANTRUM TO THE CYST, WHICH SUCCESSFULLY TAMPONADED AND RESOLVED THE BLEEDING. TWO PIGTAIL STENTS WERE PLACED THROUGH THE AXIOS STENT, AND THE STENT WAS NOTED TO BE IN GOOD POSITION. ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERCP) SHOWED A PANCREATIC LEAK IN THE HEAD OF THE PANCREAS. TWO PANCREATIC DUCT (PD) STENTS WERE PLACED TO BRIDGE THE LEAK. ON (B)(6) 2015, THE PATIENT'S PAIN HAD RESOLVED, AND A COMPUTED TOMOGRAPHY (CT) SCAN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury

  MAUDE report 8011554 ↗
• InjuryOct 28, 2018Difficult to Remove; Use of Device Problem; Human-Device Interface Problem; Migration; Difficult to Remove; Use of Device Problem; Human-Device Interface Problem; Migration

  BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT THROUGH A LITERATURE ARTICLE ENTITLED "THE BURIED LUMEN-APPOSING METAL STENT: IS THIS A STENT PROBLEM, A LOCATION PROBLEM, OR BOTH?" WRITTEN BY SHAYAN IRANI AND RICHARD A. KOZAREK. ACCORDING TO THE ARTICLE, A 10MM X 15MM AXIOS STENT WAS IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A 5.5 CM RECURRENT PAINFUL SEPTATED HEPATIC CYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) GUIDED HEPATIC CYSTGASTROSTOMY WITH LUMEN-APPOSING METAL STENT (LAMS) PLACEMENT PROCEDURE PERFORMED IN (B)(6) 2015. THE HEPATIC CYST WAS ABUTTING THE GASTRIC ANTRUM, WITH A WALL DISTANCE OF LESS THAN 1 CM. THE STENT WAS NOTED TO BE IN GOOD POSITION FROM THE GASTRIC ANTRUM TO THE CYST, WITH A FULLY EXPANDED FLANGE. AN ADDITIONAL 7F PIGTAIL STENT WAS PLACED THROUGH THE LAMS. IN (B)(6) 2015, 6 WEEKS POST STENT PLACEMENT, THE PATIENT EXPERIENCED NOCTURNAL FEVER AND PAIN. A CT SCAN SHOWED THAT MOST OF THE CYST HAD DECOMPRESSED WITH THE EXCEPTION OF AN UNDRAINED COMPONENT BEHIND THE EXISTING SEPTATION. DUE TO CONCERN FOR A LIVER ABSCESS, THE PATIENT UNDERWENT AN ENDOSCOPIC ESOPHAGOGASTRODUODENOSCOPY (EGD). AT THIS TIME, THE STENT WAS NO LONGER VISIBLE AND ONLY THE 7F PIG

  Patient problems: Abscess; Fever; Pain; Unspecified Infection

  MAUDE report 8011538 ↗
• InjuryOct 26, 2018Difficult to Remove; Use of Device Problem; Human-Device Interface Problem; Migration; Difficult to Remove; Use of Device Problem; Human-Device Interface Problem; Migration

  BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT THROUGH A LITERATURE ARTICLE ENTITLED "THE BURIED LUMEN-APPOSING METAL STENT: IS THIS A STENT PROBLEM, A LOCATION PROBLEM, OR BOTH?" WRITTEN BY SHAYAN IRANI AND RICHARD A. KOZAREK. ACCORDING TO THE ARTICLE, IN (B)(6) 2014, THE PATIENT DEVELOPED CHOLECYSTITIS MANIFESTED BY PERICHOLECYSTIC FLUID. ON (B)(6) 2014, A 10MM X 15MM AXIOS STENT WAS IMPLANTED IN A TRANSGASTRIC POSITION IN THE GALLBLADDER DURING AN ENDOSCOPIC ULTRASOUND (EUS) GALLBLADDER DRAINAGE WITH LUMEN-APPOSING METAL STENT (LAMS) PLACEMENT PROCEDURE. THE WALL DISTANCE TO THE CYST WAS LESS THAN 1 CM. THE STENT WAS NOTED TO BE IN GOOD POSITION FROM THE GASTRIC ANTRUM TO THE GALLBLADDER ONCE DEPLOYED, AND THE FLANGE WAS NOTED TO BE FULLY EXPANDED. ON (B)(6) 2015, THE PATIENT DEVELOPED A FEVER AND WAS OBSERVED TO HAVE RECURRENT CHOLECYSTITIS/CHOLANGITIS. AN ERCP WAS PERFORMED, DURING WHICH THE STENT COULD NOT BE SEEN ENDOSCOPICALLY, BUT WAS VISIBLE ON FLUOROSCOPY. THE STENT WAS FOUND TO BE COMPLETELY BURIED WITH ONLY A SMALL AREA OF HEAPED UP GRANULATION. THE STENT WAS CANNULATED AND A 7F X 5CM PIGTAIL STENT WAS PLACED THROUGH THE STENT. ON (B)(6) 2015, THE PATIENT DEVEL

  Patient problems: Fever; Inflammation

  MAUDE report 8011030 ↗
• InjuryMar 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT WAS TO BE IMPLANTED TRANSMURALLY FROM THE DISTAL ESOPHAGUS TO THE STOMACH DURING AN AXIOS PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE STENT WAS BEING PLACED TO BRIDGE AN ANASTOMOTIC STRICTURE AT THE GASTROESOPHAGEAL (GE) JUNCTION. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST FLANGE WAS SUCCESSFULLY DEPLOYED. HOWEVER, AFTER DEPLOYMENT, THE FIRST FLANGE WAS VISUALIZED ENDOSCOPICALLY AND IT WAS NOTED THAT THE STENT APPEARED TO BE TWISTED AS IT WENT INTO THE CATHETER. THE PHYSICIAN DECIDED TO DISCONTINUE PLACEMENT OF THIS STENT, AND THE STENT WAS THEN FULLY DEPLOYED IN THE PATIENT'S ESOPHAGUS FOR RETRIEVAL. REPORTEDLY, THE SECOND FLANGE WAS DIFFICULT TO DEPLOY, AND COULD ONLY BE DEPLOYED AFTER UNLOCKING BOTH THE CATHETER AND STENT LOCKS AND JIGGLING THE DELIVERY SYSTEM'S HANDLE. THE FULLY DEPLOYED STENT WAS RETRIEVED FROM THE PATIENT'S ESOPHAGUS WITH FORCEPS. AN EXAMINATION OF THE STENT AFTER DEPLOYMENT NOTED THAT THE IT WAS NOT TWISTED. THE STENT APPEARED TO BE UNDAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER AXIOS STENT AND DELIVERY SYSTEM. THERE WERE NO PATIENT COMPLICATIONS RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7324839 ↗
• MalfunctionDec 27, 2016Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COLD AXIOS STENT WAS TO BE IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING DEPLOYMENT OF THE SECOND FLANGE OF THE AXIOS STENT, THE PHYSICIAN ACCIDENTALLY PULLED ON THE HANDLE OF THE DELIVERY SYSTEM TOO QUICKLY, WHICH PULLED THE FIRST FLANGE OF THE STENT OUT OF THE TARGET SITE AND DEPLOYED THE SECOND FLANGE IN THE PATIENT'S STOMACH. THE STENT REMAINED ATTACHED TO THE DELIVERY SYSTEM AND THE PHYSICIAN WAS ABLE TO "RECAPTURE" THE STENT INTO THE CATHETER. THE STENT WAS THEN REMOVED FROM THE PATIENT ON THE DELIVERY SYSTEM. HOWEVER, AS THE DEVICE WAS REMOVED FROM THE SCOPE, THE STENT DETACHED FROM THE DELIVERY SYSTEM AND BECAME STUCK INSIDE THE SCOPE, JUST DISTAL TO THE BIOPSY CAP. THE PHYSICIAN WAS UNABLE TO REMOVE THE STENT FROM THE SCOPE BY HAND. THE SCOPE WAS THEN REMOVED FROM THE PATIENT AND THE DELIVERY SYSTEM WAS REINSERTED INTO THE SCOPE. THE STENT WAS SUCCESSFULLY PUSHED OUT OF THE SCOPE WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER COLD AXIOS STENT AND DELIVERY SYSTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6206595 ↗