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

Model Number M00553540

Device Problems Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

Block h: imdrf device code a0401 captures the reportable event of handle break.Imdrf device code a150201 captures the reportable event of stent failure to deploy.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the bile duct for a biliary drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2023.During the procedure, the handle was broken, and the stent could not be deployed at all.The stent was then removed from the patient, fully covered by the outer sheath.The procedure was discontinued in consideration of the patient's safety, and it was noted the team planned to assess the patient in the coming days and reschedule the procedure.It was later reported the puncture site had since spontaneously closed according to the physician.As of (b)(6) 2023, another procedure had been reportedly scheduled, however the procedure date was not known.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h: imdrf device code a0401 captures the reportable event of handle break.Imdrf device code a150201 captures the reportable event of stent failure to deploy.Block h10: the axios stent and electrocautery enhanced delivery system were received for analysis.Visual inspection found that the stent was fully covered and undeployed on the delivery system, and the outer sheath was twisted.The control hub was not returned as it was detached.The delivery system was disassembled during the destructive inspection to identify the torsion (rotational damage), and it was found that the outer sheath was twisted.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported events of handle breakage and stent failure to deploy because the control hub was not returned as it was detached from the handle, and the outer sheath was found to be twisted during the destructive inspection.The investigation concluded that the handle detachment was most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician (force applied).A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.During the destructive inspection of the delivery system, the outer sheath was found to be twisted, indicating torsion or rotational damage.The axios stent and electrocautery enhanced delivery system directions for use state, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope." the additional investigation finding of the outer sheath being twisted and the stent's unsuccessful deployment may be most likely traced to the user not following the manufacturer's instructions.Therefore, a review and analysis of all available information indicated that the most probable cause is failure to follow instructions.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the bile duct for a biliary drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2023.During the procedure, the handle was broken, and the stent could not be deployed at all.The stent was then removed from the patient, fully covered by the outer sheath.The procedure was discontinued in consideration of the patient's safety, and it was noted the team planned to assess the patient in the coming days and reschedule the procedure.It was later reported the puncture site had since spontaneously closed according to the physician.As of october 19, 2023, another procedure had been reportedly scheduled, however the procedure date was not known.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: 18056683
• MDR Text Key: 327195580
• Report Number: 3005099803-2023-05869
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553540
• Device Catalogue Number: 5354
• Device Lot Number: 0031929378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• 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