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

Model Number	20226
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A 8.0x40x135cm and a 7.0x60x135cm express-b-i ld stents were advanced for treatment.However, during the procedure, both stents failed to advance through sheath.The procedure was aborted and there were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: an express ld was returned for analysis.The recommended introducer sheath size for this express ld device is a 6fr sheath.The investigator was unable to insert the device into the sheath as the stent was damaged and was already moved on the balloon and more interaction could damage the device further.A visual examination of the returned device confirmed that the balloon was tightly folded and had not been subjected to positive pressure.No issues were noted with the balloon material.The stent of the device had moved approximately to a position of 6mm proximal of the distal markerband on the device.The first two rows of the distal stent struts were found to be lifted/damaged.No issues were noted with the tip of the device.No other issues were identified with the returned device during analysis.
Event or Problem Description
It was reported that the procedure was cancelled.A 8.0x40x135cm and a 7.0x60x135cm express-b-i ld stents were advanced for treatment.However, during the procedure, both stents failed to advance through sheath.The procedure was aborted and there were no patient complications reported.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12303628
• Report Number: 2134265-2021-09853
• Device Sequence Number: 3532537
• Product Code: NIO
• UDI-Device Identifier: 08714729392477
• UDI-Public: 08714729392477
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 04/12/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0027129815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1