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

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

Patient Problem Insufficient Information (4580)

Event Date 09/03/2021

Event Type  Death  

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a hot axios stent was successfully implanted transgastric to the pancreas to treat a walled-of-necrosis (won) during an endoscopic ultrasound (eus) guided procedure performed in (b)(6) 2021.Three days post stent placement, the patient began to decompensate due to a ruptured cyst.A surgery was performed for cyst debridement.The patient remained in the hospital.The patient continued to decompensate and the patient passed away the third week of (b)(6) 2022.In the physician's assessment, it is unknown if there was a relationship between the patient's decompensation/death and the axios stent.The patient was reported to be very sick which may have contributed to the patient's death.There was no alleged malfunction of the axios stent.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Exact date unknown; event occurred three days post stent placement in (b)(6) 2021.The complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.Approximated based on the information that the event occurred in (b)(6) 2021.(b)(4).The patient expired with the stent implanted and the stent 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 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: 13602741
• MDR Text Key: 286151596
• Report Number: 3005099803-2022-01001
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/25/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/25/2022
• 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): Death; Required Intervention
• Patient Sex: Male