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

Model Number	M00553690
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the name of the healthcare facility is (b)(6) medical ctr.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to pancreas to treat a pseudocyst during a stent placement procedure performed on (b)(6) 2023.During the procedure, when stent deployment was attempted, the distal flange of the axios stent was unable to deploy.The stent was partially deployed on the delivery system when it was removed from the patient.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: the name of the healthcare facility is (b)(6) medical ctr.The healthcare facility address is (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: an axios stent and electrocautery-enhanced delivery system were received for analysis.The stent was received partially deployed and the delivery system was received in position 2.During functional inspection, the catheter lock was unlocked by sliding it to the right and then the catheter control hub was moved up and down.The catheter was able to advance through the luer without resistance.Lastly, the stent hub was moved down to the second and fourth position and the stent was able to be deployed.The length of the stent was measured and found to be within specification.No visible problems were noted to the stent and delivery system.Product analysis confirmed the reported event of stent partially deployed because the stent was received partially deployed.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, stent partially deployed is noted within the ifu as a potential adverse event associated with the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to pancreas to treat a pseudocyst during a stent placement procedure performed on (b)(6) 2023.During the procedure, when stent deployment was attempted, the distal flange of the axios stent was unable to deploy.The stent was partially deployed on the delivery system when it was removed from the patient.There were no patient complications reported as a result of this event.

• 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: 17611047
• Report Number: 3005099803-2023-04527
• Device Sequence Number: 6534919
• Product Code: PCU
• UDI-Device Identifier: 00191506008093
• UDI-Public: 00191506008093
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K203132
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: 06/08/2024
• Device Model Number: M00553690
• Device Catalogue Number: 5369
• Device Lot Number: 0030684111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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