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

Model Number M00553650

Device Problem Positioning Problem (3009)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/23/2023

Event Type  Injury  

Manufacturer Narrative

Block e1 (initial reporter facility name): the initial reporter's facility name is (b)(6).Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.

Event Description

It was reported to boston scientific corporation on (b)(6)2023 that an axios stent and electrocautery-enhanced delivery system was implanted transgastric to pancreas to treat a peripancreatic fluid retention during a pancreatic cyst gastric (intestinal) bypass with axios stent placement procedure performed on (b)(6) 2023.During the procedure, the axios stent was placed in an "abnormal" position.The stent remained implanted and a 20mm axios stent was placed in another puncture route to drain the lesion.Hemostasis was then confirmed endoscopically and the procedure was completed.The physician planned to wait for a few days for the 20mm axios stent to expand and insert an endoscope to attempt to retrieve the prosthetic material that is left behind while performing necrosectomy.Note: no further information has been obtained despite good faith efforts.

• 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: 17098284
• MDR Text Key: 316932632
• Report Number: 3005099803-2023-03113
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: 08714729904595
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153088
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• 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: 0030999873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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: 63 YR
• Patient Sex: Male