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	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent movement on balloon occurred.An 8.0x30x135cm express ld stent was selected for treatment on the patient.After it entered the sheath, it displaced on the balloon and slightly migrated within the balloon area.The device was simply pulled out and was replaced with another of the same model to complete the procedure.There were no complications reported, and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual and tactile examination was done on the balloon, stent, tip, and shaft of the returned express ld device.The balloon was not tightly wrapped and had been subjected to positive pressure.No issues were noted with the balloon material.The device was received with the stent detached which was not returned.No issues were noted with the tip of the device.No issues along the length of the device were noted.
Event or Problem Description
It was reported that stent movement on balloon occurred.An 8.0x30x135cm express ld stent was selected for treatment on the patient.After it entered the sheath, it displaced on the balloon and slightly migrated within the balloon area.The device was simply pulled out and was replaced with another of the same model to complete the procedure.There were no complications reported, and the patient status was stable.

• 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: 18609484
• Report Number: 2124215-2024-04944
• Device Sequence Number: 2441287
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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: 0031170927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/04/2024
• 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