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

Model Number	20226
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The 75% stenosed target lesion was located in the renal artery.A 8.0x20x135 cm express ld stent was selected for use.However, it was found that the balloon was already expanded when unwrapping the package.The device was not used and completed the procedure with another of same device.There were no patient complications reported.Patient was stable.
Event or Problem Description
It was reported that stent dislodgement occurred.The 75% stenosed target lesion was located in the renal artery.A 8.0x20x135 cm express ld stent was selected for use.However, it was found that the balloon was already expanded when unwrapping the package.The device was not used and completed the procedure with another of same device.There were no patient complications reported.Patient was stable.
Additional Manufacturer Narrative
H6 - device codes: corrected to material integrity problem.Device evaluated by mfr.: express-b-i ld pmtd 8.0x20x135 cm was received for analysis.The indicated introducer sheath size for this express ld device is a 6fr.The customer's sheath was not returned for analysis.During analysis the investigator successfully advanced the device through a boston scientific 6fr sheath without any resistance or issues noted.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 crimped in the correct location on the balloon with no evidence of damage or any other issues noted.No issues were noted with the tip of the device.A visual and tactile examination identified no kinks or issues with the shaft of the device.
Additional Manufacturer Narrative
H6 - device codes: corrected to material integrity problem.
Event or Problem Description
It was reported that stent dislodgement occurred.The 75% stenosed target lesion was located in the renal artery.A 8.0x20x135 cm express ld stent was selected for use.However, it was found that the balloon was already expanded when unwrapping the package.The device was not used and completed the procedure with another of same device.There were no patient complications reported.Patient was stable.

• 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: 17939061
• Report Number: 2124215-2023-54289
• Device Sequence Number: 2956998
• Product Code: NIO
• UDI-Device Identifier: 08714729392460
• UDI-Public: 08714729392460
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2023

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: 11/29/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0028471835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 10/16/2023; 11/09/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/02/2023; 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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
• Patient Sex: Unknown