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

Model Number M00553540

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

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

Event Date 12/19/2023

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 to treat a periampullary carcinoma with failed common bile duct cannulation during an endoscopic ultrasound (eus) guided choledochoduodenostomy procedure performed on (b)(6) 2023.During the procedure, the stent first flange was deployed; however, the first flange did not fully expand.The second flange was then attempted to be deployed, but the whole stent moved out of the common bile duct and into the duodenum.The stent was removed using forceps and the procedure was completed using a fully covered biliary stent.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Imdrf device code a1502 captures the reportable event of stent positioning issue.

• 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: 18467289
• MDR Text Key: 332336967
• Report Number: 3005099803-2023-07029
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553540
• Device Catalogue Number: 5354
• Device Lot Number: 0031929442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• 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 Age: 56 YR