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

Model Number M00553570

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/13/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name, address, and phone number: (b)(6).Imdrf patient code e0506 captures the reportable patient complication of bleeding.Impact code f08 captures additional hospitalization to monitor patient's condition due to bleeding.

Event Description

It was reported to boston scientific corporation on march 13,2023 that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to pancreas to treat a walled-off-necrosis (won) during an endosonography procedure performed on (b)(6) 2023.During the procedure.Bleeding was noted in the stomach after stent placement.The axios stent was removed from the patient with forceps, and the procedure was completed.The walled-off-necrosis was drained through the puncture site and the size has been reduced.The patient was monitored in the (imc) intermediate care unit for one night due to bleeding.On (b)(6) 2023, the patient was discharged.

• 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: 16708757
• MDR Text Key: 312973588
• Report Number: 3005099803-2023-01905
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: M00553570
• Device Catalogue Number: 5357
• Device Lot Number: 0029825355
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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): Hospitalization