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

Model Number	20226
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter first name: (b)(6).
Event or Problem Description
It was reported that the stent dislodged inside the patient.The 90-99% stenosed target lesion was located in a non-tortuous and severely calcified artery.A 6.0 x 20 x 75cm express ld iliac biliary balloon expandable stent was selected for use in the superior mesenteric artery to treat hypogastric stenosis.However, during the procedure, the stent dislodged from the balloon.It migrated to the left internal iliac artery.Attempts were made to remove the stent via surgery, but it was unsuccessful.Since the stent embolized distally, and was unable to be retrieved, the procedure was cancelled.The patient condition was reported as okay and then discharged home.

• 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: 17413416
• Report Number: 2124215-2023-37367
• Device Sequence Number: 7182007
• Product Code: NIO
• UDI-Device Identifier: 08714729392132
• UDI-Public: 08714729392132
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/28/2023

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: 05/20/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0027355214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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: Other
• Patient Sex: Unknown