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	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that stent moved on the balloon.During preparation, when a 7.0x30x135cm express ld iliac / biliary stent was taken out of the package, it was noted that the stent was loose on the balloon.The procedure was completed using an alternate device and there were no patient complications reported.
Event or Problem Description
It was reported that stent move on balloon occurred.During preparation, when a 7.0x30x135cm express ld iliac / biliary stent was came out of the package, it was noted that the stent was loose on the balloon.The procedure completed using an alternate device and there were no patient complications reported.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.Updated fields: g1 mfr contact first name, mfr contact last name, mfr contact phone number, mfr contact email.Device evaluated by manufacturer: an express-b-i ld, pmtd, 7.0x30x135cm was received for analysis.A visual examination identified that the stent had moved approximately 2mm proximally on the balloon catheter.A visual examination found no damage to the displaced stent.No other issues were identified with the stent.A visual examination identified that the balloon of the device was received tightly folded which indicates it had not been subjected to positive pressure.A visual examination identified no issues with the balloon material.A visual examination identified no issues with the tip of the device.A visual and tactile examination identified no damage or issues with the shaft of the device.

• 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: 17054354
• Report Number: 2124215-2023-26282
• Device Sequence Number: 3479801
• Product Code: NIO
• UDI-Device Identifier: 08714729579694
• UDI-Public: 08714729579694
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 09/25/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030216595
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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