MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Axios?; unit, electrosurgical, endoscopic (with or without accessories)

Model Number	M00553640
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
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 duodenal bulb to treat acute cholecystitis during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2026.It was reported that the patient had an axios stent implanted and a cook 7 fr x 4cm double pigtail through stent went through the axios stent.The patient came back for a follow up and axios removed with a rat tooth forceps when the physician noticed that there was severe ulceration around the contralateral wall of duodenum.The patient was treated with high dose of ppi (proton pump inhibitor).It was also reported that the patient was not suitable for laparoscopic cholecystectomy due to many underlying conditions, so the gi was consulted for axios placement.There were no patient complications reported as a result of this event at this time.Note: it was reported that the axios stent was intended to be implanted during a pancreatic cystic gastrectomy with gallbladder drainage - acute cholecystitis 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 indicated for a gallbladder drainage - acute cholecystitis.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number.We are unable to provide the device manufacture date.If additional details become available, a supplemental report will be submitted.Block h6: imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf patient code f2303 captures the reportable event of ulcer.

• Brand Name: Axios?
• 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 ; +1(914)571-6918
• MDR Report Key: 50128666
• Report Number: 3005099803-2026-03172
• Device Sequence Number: 5584394
• Product Code: KNS
• UDI-Device Identifier: 08714729904588
• UDI-Public: (01)08714729904588
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M00553640
• Device Catalogue Number: M00553640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/11/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown