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

Model Number M00553660

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

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

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: the reported healthcare facility is: (b)(6).Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f19 captures the reportable event of surgical intervention performed to remove the stent.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the jejunum during an endoscopic ultrasound (eus) directed transgastric endoscopic retrograde cholangiopancreatography (ercp) (edge) procedure performed on (b)(6) 2023.During the procedure, the first flange was deployed; however, there was a 7-10 second delay in the opening of the flange.Once the first flange fully expanded, the second flange was then deployed; however, it did not expand which resulted in the stent moving out of its position and into the excluded stomach.The puncture site was closed using two non-boston scientific clips and another axios stent was implanted.The patient was sent for surgery the same day to remove the original stent.The patient was admitted to the hospital for 48 hours for observation.The patient's condition at the conclusion of the procedure was reported to be fully recovered.Note: it was reported that the axios stent was placed during an endoscopic ultrasound (eus) directed transgastric endoscopic retrograde cholangiopancreatography (ercp) (edge) procedure.However, per the axios stent and electrocautery-enhanced delivery system instructions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size that are adherent to the gastric or bowel wall.The device is not indicated to be placed transgastric to the jejunum.

• 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: 18284927
• MDR Text Key: 329995078
• Report Number: 3005099803-2023-06504
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2023

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: M00553660
• Device Catalogue Number: 5366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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