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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.A 10.0x40x135 cm express ld iliac / biliary stent was selected for use.However, during unpacking it was noticed that the stent had came off the balloon.The procedure was completed with different device.No patient involvement.
Additional Manufacturer Narrative
Device evaluated by mfr.: an express ld was returned for analysis.A visual examination of the returned device confirmed that the stent was not attached to the device.Balloon sleeves were relaxed and were not tightly folded and may have been subjected to positive pressure.No issues were noted with the balloon material.Device was received with the stent detached from the delivery system.A visual and microscopic examination found no damage to the stent.No issues were noted with the of the device's tip.A visual and tactile examination identified no issues along the length of the device.This concludes the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.A 10.0x40x135 cm express ld iliac / biliary stent was selected for use.However, during unpacking it was noticed that the stent had came off the balloon.The procedure was completed with different device.No patient involvement.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12804780
• Report Number: 2134265-2021-13786
• Device Sequence Number: 12133655
• Product Code: NIO
• UDI-Device Identifier: 08714729392385
• UDI-Public: 08714729392385
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 12/14/2021

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: 01/20/2023
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0025073337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2020
• 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