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

Model Number M00553650

Device Problems Entrapment of Device (1212); Use of Device Problem (1670); Connection Problem (2900); Positioning Problem (3009)

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

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and 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 Description

It was reported to boston scientific corporation on (b)(6) 2022 that a hot axios stent was to be implanted transgastric to pancreas to treat a walled-of-necrosis (won) during a pancreatic cyst gastric bypass surgery procedure performed on (b)(6) 2022.The physician was using the eus method of deployment where the second flange of the stent is deployed in the scope, and then the stent is released from the scope by advancing the catheter and retracting the scope in a 1:1 fashion.During the procedure, the hot axios handle was rotated when locking onto the scope and there was difficulty locking the luer lock onto the scope.During deployment, after the first flange was released, the second flange was fully deployed inside the scope; however, the second flange was unable to release from the scope.The stent was removed together with the scope and the procedure was completed using another device.There were no patient complications reported as a result of this event.It was reported that the handle was rotated as the device was luer locked to the scope.The hot axios stent and delivery system directions for use state, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.".

Event Description

It was reported to boston scientific corporation on march 29, 2022 that a hot axios stent was to be implanted transgastric to pancreas to treat a walled-of-necrosis (won) during a pancreatic cyst gastric bypass surgery procedure performed on (b)(6) 2022.The physician was using the eus method of deployment where the second flange of the stent is deployed in the scope, and then the stent is released from the scope by advancing the catheter and retracting the scope in a 1:1 fashion.During the procedure, the hot axios handle was rotated when locking onto the scope and there was difficulty locking the luer lock onto the scope.During deployment, after the first flange was released, the second flange was fully deployed inside the scope; however, the second flange was unable to release from the scope.The stent was removed together with the scope and the procedure was completed using another device.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 luer locked to the scope.The hot axios stent and delivery system directions for use state, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.".

Manufacturer Narrative

Block e1: initial reporter city: (b)(6).Block h6: medical device problem code a1502 captures the reportable event of stent first flange difficult to position.Block h10: an axios electrocautery enhanced delivery system was received for analysis; the stent was not returned.The deployment hub was returned in position "2".Visual examination of the returned device found the catheter damaged at the distal end.The luer lock was detached and the inner sheath was kinked.A destructive inspection was performed and the handlle was disassembled to inspect the inner part of the lad nose.Also, it was necessary to destroy the delivery system to identify torsion (rotational damage); however, the outer sheath was received in good condition and no evidence of rotational damages were found.Microscopic inspection was performed and evidence of adhesive in the lad nose and the luer lock was found.No other problems were noted to the stent and delivery system.The investigation concluded that the observed failures of outer sheath damaged and inner sheath kinked were likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, and/or the technique used by the user, limited the performance of the device and contributed to the outer sheath damaged and inner sheath kinked.The reported event of stent first flange difficult to position could not be confirmed because this failure occurred during the procedure and it is not possible to replicate them in the laboratory analysis.A labeling review was performed and, from the information available, this device was used in a manner inconsistent per 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 ifu states, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope." the investigation concluded that luer detached was likely to have occurred due to factors encountered during the manufacturing of the device.An investigation is under way to address this problem.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 14172651
• MDR Text Key: 289897040
• Report Number: 3005099803-2022-02058
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: 08714729904595
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153088
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Device Lot Number: 0028275568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• 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