MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC

Lot Number 29919092

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2023

Event Type  malfunction  

Event Description

The entire express stent system got stuck on the.035 amplatz platinum.The express stent system was unable to be inserted over the wire or removed over the wire, so the express stent system was removed with the amplatz wire.The express stent was intact on the wire.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 16582384
• MDR Text Key: 311683164
• Report Number: 16582384
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2023,02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 29919092
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Race: White