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

Model Number	M00553670
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Advance (2920)
Health Effect - Clinical Codes	Purulent Discharge (1812); Biliary Leak (4820)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e1108 captures the reportable patient complication of biliary leak.Imdrf patient code e231501 captures the reportable patient complication of purulent discharge.Imdrf impact code f2303 is being used to capture the medication administered to prevent infection.Imdrf impact code f2301 is being used to capture the additional device used to close the puncture site.
Event or Problem Description
Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report # 3005099803-2023-05657 for the associated device information.It was reported to boston scientific corporation that two axios stents and an electrocautery enhanced delivery system were to be implanted transgastrically into the gallbladder to treat a gallbladder infection during a gallbladder drainage procedure performed on (b)(6) 2023.During the procedure, when the first axios stent's first flange (the subject of mfr.Report 3005099803-2023-05657) was attempted to be deployed, the gray stent deployment hub was difficult to pull up and it broke and fell off of the handle.An attempt was made to deploy the stent's second flange using hemostat graspers, but it was unsuccessful, so the stent removed from the patient partially deployed on the delivery system.A second axios stent (the subject of this report) was opened, but it was not able to advance through the patient's anatomy.The puncture site was then closed using clips, and the procedure was not completed.The patient experienced bile and pus leakage at the puncture site into the peritoneal cavity, so the physician administered prophylactic antibiotics to prevent infection.The patient was reported to have been fully recovered.Note: it was reported that the axios stent and electrocautery-enhanced delivery system was used for gallbladder drainage to treat a gallbladder infection.Per the axios stent and electrocautery-enhanced delivery system instructions for use (ifu), 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 gallbladder drainage to treat a gallbladder infection.

• 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: 18002318
• Report Number: 3005099803-2023-05658
• Device Sequence Number: 12663493
• Product Code: PCU
• UDI-Device Identifier: 08714729979333
• UDI-Public: 08714729979333
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: DEN230019
• 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): 10/25/2023

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 Expiration Date: 11/27/2024
• Device Model Number: M00553670
• Device Catalogue Number: 5367
• Device Lot Number: 0030610646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown