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

Model Number	20226
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.A 8.0x30x135cm express ld iliac / biliary stent was selected for use.After a 6fr introducer sheath was introduced, the physician tried to advance the stent into the valve of the sheath but would not advance.He then pushed the stent delivery system until the stent dislodged from the balloon.The device was pulled manually and the procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.A 8.0x30x135cm express ld iliac / biliary stent was selected for use.After a 6fr introducer sheath was introduced, the physician tried to advance the stent into the valve of the sheath but would not advance.He then pushed the stent delivery system until the stent dislodged from the balloon.The device was pulled manually and the procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: express-b-i ld, pmtd, 8.0x30x135cm was received for analysis.The recommended introducer sheath size for this express ld device as per express specification is a 6fr.The sheath used by the customer was not returned for analysis.During analysis the investigator was unable to advance the device through a 6fr boston scientific sheath as the stent was no longer crimped to the balloon material.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 in the correct location on the balloon.Although in the correct position the stent was found to be no longer crimped to the balloon material suggesting that the stent had been moved on the device.This could potentially have occurred when attempting to advance the device through the sheath.No issues were noted with the tip of the device.A visual and tactile examination identified no issues along the length of the device.This concludes the product analysis.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15303031
• Report Number: 2124215-2022-31430
• Device Sequence Number: 6361223
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/30/2022

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: 07/08/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0027635462
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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