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

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2022

Event Type  malfunction  

Event Description

Boston scientific axios stent got stuck in the linear endoscope channel.This happened during placement of an axios stent for pancreatic pseudocyst drainage.A 20 mm x 10 mm stent was deployed.However on withdrawal of the stent delivery system, the stent came into the endoscope and got clogged.A second axios stent was then attempted, 15mm x 10 mm, and again this pulled out on pulling the endoscope.Subsequently 10 mm x 10 mm axial stent was successfully placed with successful deployment of the stent.Fda safety report id# (b)(4).

• Brand Name: AXIOS STENT
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13334247
• MDR Text Key: 284458042
• Report Number: MW5106903
• Device Sequence Number: 2
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White