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 Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023 that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the bile duct for the treatment of pancreatic cancer and malignant biliary obstruction during an endoscopic ultrasound (eus)- guided choledochoduodenostomy procedure performed on (b)(6) 2023.During the procedure, the stent was unable to be deployed.The physician attempted to shake and wiggle the catheter; however, the stent could still not be deployed.The stent was removed from the patient partially deployed and a non-boston scientific device was used to complete the procedure.There were no patient complications 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: 16916837
• Report Number: 3005099803-2023-02550
• Device Sequence Number: 12482311
• Product Code: PCU
• UDI-Device Identifier: 00191506008086
• UDI-Public: 00191506008086
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00553680
• Device Catalogue Number: 5368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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