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

Model Number M00553650

Device Problems Positioning Problem (3009); Activation Failure (3270); Poor Visibility (4072)

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

Event Date 11/14/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the pancreas to treat a 7.5 cm walled-of-necrosis during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2022.During the procedure, the first flange was deployed; however, the physician had difficulty visualizing the first flange under eus view and they were unable to confirm if the stent first flange expanded.Deployment of the second flange was performed; however, the stent moved out of its position and into the patient's stomach.The stent was removed using a rat tooth grasper and the procedure was not completed.There were no patient complications 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: 15914813
• MDR Text Key: 304791401
• Report Number: 3005099803-2022-07169
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: 08714729904595
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153088
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Device Lot Number: 0030289215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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
• Patient Sex: Female
• Patient Race: Black Or African American