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

Model Number	20226
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign material was present in device.An 8.0x30x135cm express ld iliac/biliary stent was selected for use in an arterial runoff procedure.However, during preparation, it was observed that the stent was so slick, and was thought to have some sort of plastic protective cover over the stent marrying it to the balloon.The device was replaced with another express ld stent, and the procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
The returned device was received for analysis.No foreign material (fm) was identified anywhere on the returned device.A visual examination found the stent to crimped in the correct position on the device.No damage or issues were noted with the stent.A visual examination identified the balloon had not been subjected to positive pressure.A visual examination identified no issues with the balloon material.A visual examination identified no issues with the tip of the device.A visual and tactile examination identified no damage or any issues to the shaft of the device.
Event or Problem Description
It was reported that foreign material was present in device.An 8.0x30x135cm express ld iliac/biliary stent was selected for use in an arterial runoff procedure.However, during preparation, it was observed that the stent was so slick, and was thought to have some sort of plastic protective cover over the stent marrying it to the balloon.The device was replaced with another express ld stent, and the procedure was completed successfully.No patient complications were reported.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19460961
• Report Number: 2124215-2024-33942
• Device Sequence Number: 12427525
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2026
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0031170926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown