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

Model Number M00553540

Device Problem Activation Failure (3270)

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

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2023-06724, 3005099803-2023-06725, and 3005099803-2023-06726 for the associated device information.It was reported to boston scientific corporation that three axios stent and electrocautery-enhanced delivery systems were to be implanted transgastric to the pancreas to treat a walled-off necrosis during an endoscopic ultrasound (eus)- guided drainage procedure performed on (b)(6) 2023.During the procedure, the axios stent was deployed; however, the stent's first flange was unable to expand.The axios stent was removed with a snare and a second axios stent was used but the same problem was observed.Subsequently, the axios stent was also removed with a snare.A third axios stent was used but the same problem was still observed.The axios stent was also removed with a snare and another axios stent was used to complete the 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: 18338199
• MDR Text Key: 330660298
• Report Number: 3005099803-2023-06726
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2024
• Device Model Number: M00553540
• Device Catalogue Number: 5354
• Device Lot Number: 0029342564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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