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

Model Number	20226
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent moved on balloon occurred, requiring placement of another stent.The over than 80% stenosed target lesion was located in the mildly tortuous and severely calcified vessel.The patient presented with bilateral common iliac artery (cia) disease, underwent a procedure using bilateral femoral access.Two 10.0x60x75cm express ld stents were placed in the ostium of the common iliac artery.During the insertion on the right side, the physician encountered resistance.Under angiography, the stent was still on the catheter, so the stent was inflated simultaneously.However, it was noted that only the top half of the stent was expanded, while the bottom part remained unexpanded.The balloon was removed, and a new balloon was advanced to inflate the unexpanded part but was unsuccessful.The physician lost wire access and had to come contralateral side with a new wire but was unable to get true lumen through the stent.Subsequently, the physician placed another wire beside the stent, crushed it against the artery wall, and placed another express ld over it to lock it in place.As per physician's opinion, the stent may have partially slid off the balloon during the procedure.The procedure was completed successfully.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: 20385421
• Report Number: 2124215-2024-61752
• Device Sequence Number: 6549148
• Product Code: NIO
• UDI-Device Identifier: 08714729392118
• UDI-Public: 08714729392118
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030355004
• 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: 09/11/2024
• Initial Report FDA Received Date: 10/07/2024
• Date Device Manufactured: 10/17/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown