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

Model Number M00553650

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

Patient Problems Abdominal Pain (1685); Flatus (1865)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was discarded 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.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that a hot axios stent was implanted in a transgastric position to treat an encapsulated necrosis (won) during an endoscopic ultrasound pancreatic cyst drainage procedure performed on (b)(6) 2021.On (b)(6) 2021, the stent was removed during a routine removal per protocol.On (b)(6) 2021, the patient experienced abdominal pain and free air was observed at the removal site.An over-the-scope-clip (otsc) treatment was performed.The patient's health was reported to be restored.The patient's current condition was reported to be fine.In the physician's assessment, there was a relationship between the abdominal pain and free air at the removal site and the axios stent.

• Brand Name: AXIOS
• 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: 12543160
• MDR Text Key: 273675660
• Report Number: 3005099803-2021-05067
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: 08714729904595
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2021

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 Expiration Date: 04/29/2023
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Device Lot Number: 0027226217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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