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

Model Number 5356

Device Problems Use of Device Problem (1670); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/03/2023

Event Type  malfunction  

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 during a gastrojejunostomy procedure performed on (b)(6) 2023.During preparation, the distal part of the delivery system was observed to be kinked.Another axios stent was used to complete the procedure.There were no reported patient complications as a result of this event.It was reported that the axios stent was implanted during a gastrojejunostomy procedure.Per the axios stent and electrocautery-enhanced delivery system instructions for use (ifu), the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with =70% fluid content, gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery, and the bile duct after failed ercp in patients with biliary obstruction due to a malignant stricture.The stent is not indicated for gastrojejunostomy procedure.

Manufacturer Narrative

Block h6: imdrf device code a04 captures the reportable investigation finding of stent cover damaged.Block h10: an axios stent and electrocautery enhanced delivery system were received for analysis.Media inspection found one gap between the tip and the outer sheath.Visual inspection revealed that the stent was fully covered, while no damages were noted on the tip of the device.Visual and microscopic inspection found that the outer sheath was kinked at the distal section.Functional inspection was performed, and no problems were noted; however, a microscopic inspection after deployment identified the stent cover was damaged.No other problems were noted with the stent or delivery system.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.Per the axios stent and electrocautery-enhanced delivery system instructions for use (ifu), the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with >=70% fluid content, gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery, and the bile duct after failed ercp in patients with biliary obstruction due to a malignant stricture.The stent is not indicated for gastrojejunostomy procedure.Based on the information available, the investigation found that the reported event of tip damaged cannot be confirmed because no damages were noted to the tip during inspection.Investigation findings do not lead to a clear conclusion about the cause of the damage found.Additionally, the kink in the distal section of the outer sheath was most likely due to procedural factors such as handling of the device, the technique of the physician, or the manner that the device was manipulated could have resulted in the kink encountered in the outer sheath.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.

• 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 morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17320388
• MDR Text Key: 319720297
• Report Number: 3005099803-2023-03774
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: SIMILAR
• 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
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2024
• Device Model Number: 5356
• Device Catalogue Number: 5356
• Device Lot Number: 0031125614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1