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

Model Number	20226
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent moved on balloon and tip detachment occurred.The 90% stenosed target lesion was located in a severely tortuous and moderately calcified vessel.A 10.0x30x135 cm express ld stent balloon expandable was selected for use.During insertion, crossing difficulties while tracking the lesion was noted and the stent partially moved off balloon.Additionally, the distal tip of the stent on the balloon became partially detached.The device was removed completely, and the procedure was completed with another of the same device.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: 20439416
• Report Number: 2124215-2024-62227
• Device Sequence Number: 7995635
• Product Code: NIO
• UDI-Device Identifier: 08714729392378
• UDI-Public: 08714729392378
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/14/2024

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: 0033295658
• 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: 09/19/2024
• Initial Report FDA Received Date: 10/14/2024
• Date Device Manufactured: 01/26/2024
• 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