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

Model Number M00553640

Device Problems Premature Activation (1484); Use of Device Problem (1670); 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 10/16/2023

Event Type  malfunction  

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 pancreas to treat a pancreatic cyst during a pancreatic cyst gastric bypass procedure performed on (b)(6) 2023.During withdrawal, the partially deployed stent was pulled together with the delivery system inside the forceps channel.The stent was retrieved from the forceps channel after the scope was removed.The procedure was completed with another axios stent.There were no patient complications reported as a result of this event.Note: it was reported that the handle was rotated as the device was locked to the scope.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.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of stent partial deployment.

Manufacturer Narrative

Blocks b5 and h6 (device codes) have been updated with the additional information received on december 6, 2023, and december 12, 2023.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Block h10: the axios stent and electrocautery enhanced delivery system were received for analysis.Visual inspection found that the stent was fully expanded and deployed, and the inner sheath was kinked and detached from the delivery system.Functional analysis was performed by moving the handle from position 2 to position 4, and no resistance was felt.No other damages were noted with the stent or the delivery system.Product analysis did not confirm the reported event of stent premature deployment.The investigation concluded that premature stent deployment cannot be confirmed because this event happened during the procedure; thus, it was not possible to replicate it in the laboratory for analysis.Additionally, the additional investigation findings of inner sheath kinking and detaching from the delivery system were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied), which could have resulted in the damages encountered in the device.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.It was reported that the handle was rotated as the device was luer-locked to the scope.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." therefore, a review and analysis of all available information indicated that the most probable cause is no problem detected.

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 pancreas to treat a pancreatic cyst during a pancreatic cyst gastric bypass procedure performed on (b)(6) 2023.During withdrawal, the partially deployed stent was pulled together with the delivery system inside the forceps channel.The stent was retrieved from the forceps channel after the scope was removed.The procedure was completed with another axios stent.There were no patient complications reported as a result of this event.Note: it was reported that the handle was rotated as the device was locked to the scope.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.Additional information received on december 6, 2023, and december 12, 2023: it was reported that the stent was removed from the patient in a state where it was not fully deployed, but it was caught in the forceps channel, and it prematurely deployed.The stent was removed together with the scope.

• 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: 18079694
• MDR Text Key: 327737209
• Report Number: 3005099803-2023-05984
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904588
• UDI-Public: 08714729904588
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K220112
• 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: 12/19/2023

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: M00553640
• Device Catalogue Number: 5364
• Device Lot Number: 0031996278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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