MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00553660
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery-enhanced delivery system was intended to be implanted in the lower esophageal sphincter (les) area to perform an esophagogastroduodenoscopy (egd) with pyloric stent placement procedure performed on (b)(6) 2023.During the procedure, axios catheter was passed through therapeutic upper scope, during step 2 the grey hub broke in half and fell off the deployment handle.The physician attempted to reattach the gray hub, but it would not deploy the first flange of the device.The procedure was completed using another axios stent.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent and electrocautery- enhanced delivery system was used to treat a pyloric stenosis.Per the axios stent and electrocautery-enhanced delivery system directions for use (dfu), 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 that are adherent to the gastric or bowel wall.The stent is not indicated for a pyloric stenosis.
Additional Manufacturer Narrative
Block h6: imdrf device code a150201 captures the reportable event of stent failure to deploy.Block h11: following an update to the axios risk documentation, this event is being reported as part of the efforts associated with boston scientific's nonconforming events and prevention investigation, (b)(4).Investigations results: with all available information, boston scientific corporation concludes that the reported events of stent failure to deploy and handle break were able to be confirmed.The device has been returned, and the stent was returned fully cover and undeployed and the control hub was returned detached form the outer sheath.These events could have been caused due to procedural factors such as lesion characteristics, handling of the device, or the technique used by the physician (force applied) that could have resulted in the damages encountered in the device, these damages could have unable to deploy the stent during the procedure.On the other hand, it was reported that the axios stent and electrocautery- enhanced delivery system was used to treat pyloric stenosis, which is not listed on the label; therefore, the code of use of device issue-misuse could be confirmed.Device technical analysis: an axios stent with electrocautery enhanced delivery system was received for analysis.During the product analysis the stent was returned fully cover and undeployed and the control hub was returned detached form the outer sheath.Labeling review: a labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use/product label.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 that are adherent to the gastric or bowel wall.The stent is not indicated for a pyloric stenosis"; however, it was reported that the axios stent and electrocautery- enhanced delivery system was used to treat a pyloric stenosis.Device history record (dhr) review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Risk review: a risk review was completed and confirmed that the event of "stent failure to deploy" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25144895
• Report Number: 3005099803-2026-01816
• Device Sequence Number: 9316584
• Product Code: KNS
• UDI-Device Identifier: 08714729951179
• UDI-Public: (01)08714729951179(17)240626(10)31901570
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2024
• Device Model Number: M00553660
• Device Catalogue Number: M00553660
• Device Lot Number: 0031901570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown