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

Model Number M00553640

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/02/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on march 09, 2022 that a hot axios stent was implanted transgastric to the pancreas treat a pancreatic pseudocyst during a pancreatic pseudocyst drainage procedure performed on (b)(6) 2022.During follow-up, a day post stent placement, bleeding was noted from the drainage tube.An emergency endoscopy procedure was performed; however, the origin of the bleeding was not known.A hemostasis device was used to address the bleeding; however, the bleeding did not stop.A surgery was performed to remove the hemostasis device and the axios stent.On (b)(6), another surgery was performed to remove part of the stomach and part of the spleen because the bleeding had not stopped.The patient's condition was reported to be fine and stable after the surgery.In the physician's assessment, there was a relationship between the bleeding and the axios stent.The physician believed the edge of the axios stent may have caused the bleeding.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 13971300
• MDR Text Key: 288385140
• Report Number: 3005099803-2022-01630
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904588
• UDI-Public: 08714729904588
• 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: 03/31/2022

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: M00553640
• Device Catalogue Number: 5364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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