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

Model Number M00553520

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Activation Failure (3270)

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

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of the stent's first flange failure to expand.Imdrf device code a1502 captures the reportable event of the stent's first flange difficult to position.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system were to be implanted in the biliary duct to treat pancreatic cancer during a biliary duct drainage procedure performed on (b)(6) 2023.During the procedure, the axios stent's first flange did not completely expand.The physician moved the catheter and applied traction to achieve the first flange expansion, but it moved out of the target site of the implant.The stent was removed from the patient partially deployed on the delivery system, and the procedure was completed with another axios stent.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system were to be implanted in the biliary duct to treat pancreatic cancer during a biliary duct drainage procedure performed on (b)(6) 2023.During the procedure, the axios stent's first flange did not completely expand.The physician moved the catheter and applied traction to achieve the first flange expansion, but it moved out of the target site of the implant.The stent was removed from the patient partially deployed on the delivery system, and the procedure was completed with another axios stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of the stent's first flange failure to expand.Imdrf device code a1502 captures the reportable event of the stent's first flange difficult to position.Block h10: the axios stent and electrocautery enhanced delivery system were received for analysis.Visual inspection found that the stent was partially deployed on the delivery system.Functional inspection was performed by sliding the catheter to the right and moving the catheter control hub up and down.The catheter passed through the luer without resistance, and the stent hub was moved down to the second and fourth positions.The stent was deployed without problems, and no resistance was felt.Media analysis showed no images related to the device, and no damages were noted.No other damages were noted with the stent or the delivery system.Product analysis did not confirm the reported events of stent first flange failure to expand and stent first flange difficult to position.The investigation concluded that the additional investigation finding of stent partial deployment was considered a known adverse event related to the use of the device and was documented in the labeling, and all reasonable steps have been taken, including both short- and long-term known complications.The reported events of stent first flange failure to expand and stent first flange difficult to position could not be confirmed because, during functional inspection of the device, the stent was deployed without problems.Therefore, a review and analysis of all available information indicated that 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.

• 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: 17765474
• MDR Text Key: 323622462
• Report Number: 3005099803-2023-04948
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2024
• Device Model Number: M00553520
• Device Catalogue Number: 5352
• Device Lot Number: 0030299501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• 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
• Patient Outcome(s): Required Intervention