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

Model Number	20226
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent dislodged outside the patient.The patient was being treated for iliac stenosis and underwent stenting.The greater than 70% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 6.0x30x75cm express ld iliac / biliary stent was advanced for treatment but failed to cross the lesion.During removal, the stent came off the wire outside the patient.Another 6.0x30x75cm express ld iliac / biliary stent was advanced but also failed to cross the lesion.The procedure was completed with a non-boston scientific stent.No patient complications were reported.
Additional Manufacturer Narrative
Returned product consisted of an express ld.A visual examination of the returned device confirmed that the balloon was tightly wrapped and had not been subjected to positive pressure.No issues were noted with the balloon material.A visual examination found the stent was detached from the balloon and was not returned with the device.No issues were noted with the tip of the device.A visual and tactile examination identified no issues along the length of the device.
Event or Problem Description
It was reported that the stent dislodged outside the patient.The patient was being treated for iliac stenosis and underwent stenting.The greater than 70% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 6.0x30x75cm express ld iliac / biliary stent was advanced for treatment but failed to cross the lesion.During removal, the stent came off the wire outside the patient.Another 6.0x30x75cm express ld iliac / biliary stent was advanced but also failed to cross the lesion.The procedure was completed with a non-boston scientific stent.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: 18720647
• Report Number: 2124215-2024-08820
• Device Sequence Number: 17729795
• Product Code: NIO
• UDI-Device Identifier: 08714729579656
• UDI-Public: 08714729579656
• 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,Followup
• Report Date (Section B): 03/28/2024

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 Expiration Date: 10/26/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030430130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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
• Patient Sex: Unknown