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

Model Number	20226
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 30apr2024.It was reported that the tightly stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.After it was pre-dilated, an 8.0 x 60 x 135cm express ld iliac/ biliary stent balloon was selected to proceed with the treatment.During the procedure, the stent would not cross the lesion.The physician tried using a stiffer wire in case the stent needed additional support, but the device would still not cross.The device was replaced for another of the same model to complete the procedure.There were no patient complications reported.However, returned device analysis revealed that the stent was damaged.
Additional Manufacturer Narrative
Device evaluated by mfr.: upon receipt at our post market quality assurance laboratory, a visual examination of the device found the stent to be crimped in the correct position on the device.The first row of distal stent struts were noted to be damaged.No other issues were noted with the stent.The balloon and the tip were also visually examined.The balloon had not been subjected to positive pressure, and there were no issues with the balloon material or tip of the device.A visual and tactile examination identified no damage or any issues to the shaft 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: 19363394
• Report Number: 2124215-2024-30453
• Device Sequence Number: 6500305
• Product Code: NIO
• UDI-Device Identifier: 08714729392484
• UDI-Public: 08714729392484
• 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
• 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 Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0033015001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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