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

Model Number	20226
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.A 9.0x30x75cm express ld iliac / biliary stent balloon was advanced for treatment.However, during the preparation, it was found that the stent was not attached to the delivery system when pulling out from the loop.The procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that stent dislodgement occurred.A 9.0x30x75cm express ld iliac / biliary stent balloon was advanced for treatment.However, during the preparation, it was found that the stent was not attached to the delivery system when pulling out from the loop.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Only the stent of the device was returned, and the balloon catheter was not returned.A visual examination found the stent to be damaged/misshapen.No other issues were noted with the stent.

• 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: 19101418
• Report Number: 2124215-2024-21979
• Device Sequence Number: 15387698
• Product Code: NIO
• UDI-Device Identifier: 08714729392316
• UDI-Public: 08714729392316
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/24/2024

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: 11/29/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030625442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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