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

Model Number	20226
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 03may2024.It was reported that difficulty advancing and tip bent occurred.The 90% stenosed target lesion was located in a sub artery.An 8.0x30x135cm express ld iliac/biliary stent balloon expandable was advanced for treatment.During introduction, it was noted that the device was difficult to go through the sheath and the front tip was a bit bent.The procedure was completed with another of the same device.No patient complications were reported, and patient status was stable.However, device analysis revealed a stent damage.
Additional Manufacturer Narrative
Device evaluated by mfr.: the express ld device was returned for analysis.The recommended introducer sheath size for this device as per dfu (directions for use) is a 6fr sheath.The investigator was unable to insert the device into the sheath ash the stent was damaged and did not want to damage it further.A visual examination of the returned device confirmed that the balloon was tightly folded and had not been subjected to positive pressure.The stent of the device was damaged on the first two stent struts on the distal end.No issues were noted with the tip of the device.

• 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: 19361571
• Report Number: 2124215-2024-30927
• Device Sequence Number: 3851632
• 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
• Report Date (Section B): 05/21/2024

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: 05/29/2026
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0031714096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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