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

Model Number	20226
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the left iliac artery.An 8.0x60x135 cm express ld iliac / biliary stent balloon expandable was selected for treatment.During introduction, it was noted that the device was bent.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual examination confirmed a stent damage on the 4th and 5th strut on the distal section, and a damage on the first strut on the proximal end.There were no issues found on the balloon material, tip, or shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the left iliac artery.An 8.0x60x135 cm express ld iliac / biliary stent balloon expandable was selected for treatment.During introduction, it was noted that the device was bent.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

• 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: 20158975
• Report Number: 2124215-2024-55825
• Device Sequence Number: 8259395
• Product Code: NIO
• UDI-Device Identifier: 08714729392484
• UDI-Public: 08714729392484
• 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): 10/03/2024

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 Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0032764186
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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