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

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

Patient Problem Abdominal Pain (1685)

Event Date 10/11/2022

Event Type  Injury  

Event Description

Reporter calling after experiencing ongoing problems after stent placement.Reporter states that "when i overeat or when eating certain foods" she experiences intense abdominal pain.She is concerned regarding a lack of a warning about overeating and the axios stent; she has experienced intense pain after overeating "more than four times" since the stent was placed on (b)(6) 2022.The pain was so intense that she went to the emergency room after an overeating episode on (b)(6) 2022.During this visit, the reporter states that the device placement was "confirmed, intact, and draining pancreatic fluid appropriately." the reporter states that she is scheduled to have her stent removed on (b)(6) 2022.

• Brand Name: AXIOS STENT
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15807196
• MDR Text Key: 303896330
• Report Number: MW5113327
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/15/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2022
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female