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

Model Number M00553530

Device Problems Positioning Problem (3009); Activation Failure (3270)

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

Event Date 11/06/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery-enhanced delivery system was to be implanted transduodenal to the common bile duct for a biliary drainage during a choledocoduodenostomy (cds) procedure performed on (b)(6) 2023.During the procedure, the second flange was not able to completely expand.While trying to appose the second flange to the lumen, it came out completely to the duodenum.The stent was removed with snares, and the patient was transferred for a percutaneous transhepatic biliary drainage (ptbd) procedure.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 stent failure to expand.Imdrf device code a1502 captures the reportable event of the stent positioning issue.Imdrf impact code f19 captures the surgical intervention performed.Imdrf impact code f2301 captures the additional device required to remove the stent.

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a1502 captures the reportable event of the stent positioning issue.Imdrf impact code f19 captures the surgical intervention performed.Imdrf impact code f2301 captures the additional device required to remove the stent.Block h10: the axios electrocautery enhanced delivery system was received for analysis.The stent was not received for analysis.Visual inspection found no damage to the delivery system.Product analysis did not confirm the reported events of stent failure to expand and stent positioning issue because the stent was not returned for analysis and these events occurred during the procedure, which was not possible to replicate in the laboratory of analysis.However, the investigation concluded that the stent positioning issue is a known potential adverse event associated with the use of the device and is documented, including both short- and long-term known complications or adverse reactions.Therefore, taking all available information into consideration, the overall root cause of the reported event is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery-enhanced delivery system was to be implanted transduodenal to the common bile duct for a biliary drainage during a choledocoduodenostomy (cds) procedure performed on (b)(6) 2023.During the procedure, the second flange was not able to completely expand.While trying to appose the second flange to the lumen, it came out completely to the duodenum.The stent was removed with snares, and the patient was transferred for a percutaneous transhepatic biliary drainage (ptbd) procedure.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: 18246898
• MDR Text Key: 329489292
• Report Number: 3005099803-2023-06354
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553530
• Device Catalogue Number: 5353
• Device Lot Number: 0031797750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: Asian