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 Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a hot axios stent was to be implanted transgastric to the pancreas to treat a pseudocyst during an endoscopic ultrasound (eus) procedure performed on an unknown date.During the procedure, the second flange could not be deployed.The stent was removed partially deployed from the patient and the procedure was completed using another axios stent.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: medical device problem code a15 captures the reportable event of stent partially deployed.Block h10: a hot axios stent and delivery system were returned for analysis.Visual examination of the returned device found the stent partially deployed.The delivery system was received in position "1".A jagwire was also returned stuck in the device.Microscopic inspection was performed and friction marks were noted on the handle and the sheath.X-ray analysis was performed to analyze the distal section of the sheath and the luer section; no damage was found.Functional inspection was performed and the stent could be released from the delivery system.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed via visual inspection.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.It may be that how the device was handled and manipulated during the procedure, limited the performance of the device and contributed to the stent partial deployment and the guidewire being stuck in the catheter.Additionally, continuous attempts to deploy the stent could have led to the friction marks on the sheath and the handle.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a hot axios stent was to be implanted transgastric to the pancreas to treat a pseudocyst during an endoscopic ultrasound (eus) procedure performed on an unknown date.During the procedure, the second flange could not be deployed.The stent was removed partially deployed from the patient and the procedure was completed using another axios stent.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: 13480376
• Report Number: 3005099803-2022-00555
• Device Sequence Number: 5387570
• Product Code: PCU
• UDI-Device Identifier: 08714729979333
• UDI-Public: 08714729979333
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K192043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: 08/09/2023
• Device Model Number: M00553670
• Device Catalogue Number: 5367
• Device Lot Number: 0027801393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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