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	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent moved on balloon.The narrowing target lesion was located in the moderately calcified and straight vessel in proximal iliac.A 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, after delivering the stent to the iliac artery using up and over approach, it was noted that the stent moved forward on the balloon delivery system.The device was removed intact and once it was safely out the sheath, it was physically observed that the stent slid slightly forward on balloon and not off balloon.The procedure was completed with another 7.0x30x75cm express ld iliac / biliary stent.The case outcome went great, with no patient consequences at all.
Additional Manufacturer Narrative
Device evaluated by mfr.: an express ld device was returned for analysis.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.No issues were noted which may have potentially contributed to the complaint incident.A visual examination found the stent had moved in a distal direction on the balloon.No issues noted with the stent.A visual and tactile examination identified no issues with the shaft of the device.A visual and tactile examination identified no issues with tip of this device.
Event or Problem Description
It was reported that stent moved on balloon.The narrowing target lesion was located in the moderately calcified and straight vessel in proximal iliac.A 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, after delivering the stent to the iliac artery using up and over approach, it was noted that the stent moved forward on the balloon delivery system.The device was removed intact and once it was safely out the sheath, it was physically observed that the stent slid slightly forward on balloon and not off balloon.The procedure was completed with another 7.0x30x75cm express ld iliac / biliary stent.The case outcome went great, with no patient consequences at all.

• 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: 15422589
• Report Number: 2124215-2022-33011
• Device Sequence Number: 2620913
• Product Code: NIO
• UDI-Device Identifier: 08714729579663
• UDI-Public: 08714729579663
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/20/2022

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: 09/02/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0027963934
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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