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

Model Number M00553650

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

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

Event Date 11/24/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: the axios electrocautery enhanced delivery system was received for analysis.The stent was not returned.Visual inspection found that the inner sheath was kinked.No other damages were noted with the delivery system.Product analysis did not confirm the reported events of a stent partially deployed and stent first flange failure to expand as there was no objective evidence or descriptive conditions to confirm the reported event.The investigation concluded that the additional investigation finding of inner sheath kinking was most likely due to procedural factors such as lesion characteristics, handling of the device, the technique used by the physician (force applied), could have resulted in the damages encountered in the device.Additionally, there is no indication of what the customer reported because the stent was not returned.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted during an endoscopic ultrasound (eus) procedure performed on november 24, 2023.During the procedure, the stent first flange did not deploy properly.The stent was partially deployed on the delivery system when it was removed from the patient and the procedure was completed with another axios stent.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.

• 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: 18563934
• MDR Text Key: 333479543
• Report Number: 3005099803-2024-00051
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: 08714729904595
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Device Lot Number: 0032027101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2023
• 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