MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number	M00553680
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
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 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable investigation finding of stent partially deployed.Block h10: an axios stent and electrocautery enhanced delivery system were returned for analysis.Visual examination of the returned device found the stent partially deployed.The delivery system was returned in position 2.No other problems were noted to the stent and delivery system.The investigation concluded that the observed failure of lumen pusher wire was pushed out of the handle was likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, the technique used by the physician and/or the interaction with the guidewire, limited the performance of the device and contributed to the observed failure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Additionally, incomplete deployment is noted within the manufacturer's labeling as a known possible adverse event related to the use of the device.Taking all available information into consideration, the investigation concluded that the reported event of stent partially deployed is a known potential complication associated with the use of the device in the manufacturer's labeling.Therefore, the most probable root cause is known inherent risk of device.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• Common Device Name: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18058103
• Report Number: 3005099803-2023-05985
• Device Sequence Number: 6849093
• Product Code: PCU
• UDI-Device Identifier: 00191506008086
• UDI-Public: 00191506008086
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K220112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

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: 10/24/2024
• Device Model Number: M00553680
• Device Catalogue Number: 5368
• Device Lot Number: 0031500987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown