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

Model Number M00553550

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.

Event Description

It was reported to boston scientific corporation on april 06, 2023 that an axios stent and electrocautery-enhanced delivery system was to be implanted in the pancreas to treat a walled-off necrosis and pseudocyst during a drainage procedure performed on (b)(6) 2023.During the procedure, the distal flange was unable to deploy.The axios stent was partially deployed when it was removed from the patient.The procedure was completed with another axios stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

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 together with the retainer clip.Visual and microscopic inspections found the nose cone broken.Also, the outer sheath was kinked and a couple of wires was damaged.No other problems were noted to the stent and delivery system.Product analysis confirmed the reported event of stent partially deployed.It is most likely that procedural factors such as lesion characteristics, handling of the device, the interaction with the scope (position of the elevator), and the technique used by the physician, limited the performance of the device and contributed to the observed events of nose cone broken, outer sheath kinked, and couple of wires damaged.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 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 in the pancreas to treat a walled-off necrosis and pseudocyst during a drainage procedure performed on (b)(6)2023.During the procedure, the distal flange was unable to deploy.The axios stent was partially deployed when it was removed from the patient.The procedure was completed with another axios stent.There were no patient complications reported as a result of this event.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• Type of Device: 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: 16753146
• MDR Text Key: 313940374
• Report Number: 3005099803-2023-02038
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

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
• Device Operator: Health Professional
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0029871630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1