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

Model Number	H74938046960750
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent moved on balloon.A 9.0x60x75cm express ld iliac / biliary stent balloon expandable was selected for treatment.During the procedure, the stent moved on balloon.No patient complications were reported.
Additional Manufacturer Narrative
G4 - additional premarket / 510(k): p090003.
Additional Manufacturer Narrative
G4 - additional premarket / 510(k): p090003.
Event or Problem Description
It was reported that stent moved on balloon.A 9.0x60x75cm express ld iliac / biliary stent balloon expandable was selected for treatment.During the procedure, the stent moved on balloon.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: 21277044
• Report Number: 2124215-2025-02096
• Device Sequence Number: 8533123
• Product Code: NIO
• UDI-Device Identifier: 08714729392354
• UDI-Public: 08714729392354
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: 10/05/2026
• Device Model Number: H74938046960750
• Device Catalogue Number: H74938046960750
• Device Lot Number: 0032583193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 10/06/2023
• 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