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

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device remains implanted; therefore, a failure 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 june 16, 2021 that hot axios stents were implanted in multiple patients during an endoscopic ultrasound (eus) with axios placement procedures performed on unknown dates for multiple indications.According to the physician team at (b)(6), the axios stents were implanted during unnecessary procedures on patients who did not need certain interventions leading to unknown patient complications.There were no malfunctions or issues noted to the devices.The stents remain implanted; however, different interventions will be required to be performed.The implanting physician was let go from the hospital.

• 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: 12142993
• MDR Text Key: 260715848
• Report Number: 3005099803-2021-03328
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/09/2021
• 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