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

Model Number M00553670

Device Problems Use of Device Problem (1670); Positioning Problem (3009); Activation Failure (3270)

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

Event Date 10/31/2023

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 transgastric to the jejunum for the treatment of pancreatic head mass during a gastrojejunostomy procedure performed on (b)(6) 2023.During the procedure, there was difficulty encountered when deploying the stent.The stent eventually fully deployed; however, the first flange did not expand which resulted to the stent moving out of its position.The stent was clipped on each side to mark the location of the puncture.The stent was then removed and the puncture site was closed using resolution clips.Another axios stent was implanted to complete the procedure.There were no patient complications as a result of this event.Note: it was reported that the axios stent was intended to be placed during a gastrojejunostomy 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 with >= 70% fluid content that are adherent to the gastric or bowel wall.The device is not indicated for placement transgastric to the jejunum.

Manufacturer Narrative

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

• 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: 18160035
• MDR Text Key: 328404676
• Report Number: 3005099803-2023-06237
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729979333
• UDI-Public: 08714729979333
• 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: Physician
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553670
• Device Catalogue Number: 5367
• Device Lot Number: 0032305003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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