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

Model Number	H74938047960130
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the iliac artery.A 9.0x60x135 cm express ld stent balloon was selected for procedure.During the procedure, the stent unintentionally dislodged before reaching the lesion.The physician then released the stent at its current location.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Premarket / 510(k) #: k133110, p090003.
Additional Manufacturer Narrative
Premarket / 510(k) #: k133110, p090003.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the iliac artery.A 9.0x60x135 cm express ld stent balloon was selected for procedure.During the procedure, the stent unintentionally dislodged before reaching the lesion.The physician then released the stent at its current location.The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the stent was not removed and a mustang balloon was used to treat the lesion.
Additional Manufacturer Narrative
Premarket / 510(k) #: k133110, p090003.Device evaluated by mfr: the express ld was returned for analysis.A visual examination of the returned device confirmed that the balloon was not folded and was subjected to positive pressure.Liquid noted inside balloon.A visual examination identified that the device was received with the stent already detached from the balloon material.The detached stent was not returned with the device.No issues were noted with the tip of the device.A visual and tactile examination identified no issues along the length of the device.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the iliac artery.A 9.0x60x135 cm express ld stent balloon was selected for procedure.During the procedure, the stent unintentionally dislodged before reaching the lesion.The physician then released the stent at its current location.The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the stent was not removed and a mustang balloon was used to treat the lesion.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the iliac artery.A 9.0x60x135 cm express ld stent balloon was selected for procedure.During the procedure, the stent unintentionally dislodged before reaching the lesion.The physician then released the stent at its current location.The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the stent was not removed and a mustang balloon was used to treat the lesion.The express ld was returned for analysis and investigation was completed on 01sep2025.A visual examination of the returned device confirmed that the balloon was not folded and was subjected to positive pressure.Liquid noted inside balloon.A visual examination identified that the device was received with the stent already detached from the balloon material.The detached stent was not returned with the device.No issues were noted with the tip of the device.A visual and tactile examination identified no issues along the length of the device.
Additional Manufacturer Narrative
E1 - updated initial reporter zip/post code.Premarket / 510(k) #: k133110, p090003.Device evaluated by mfr: the express ld was returned for analysis.A visual examination of the returned device confirmed that the balloon was not folded and was subjected to positive pressure.Liquid noted inside balloon.A visual examination identified that the device was received with the stent already detached from the balloon material.The detached stent was not returned with the device.No issues were noted with the tip of the device.A visual and tactile examination identified no issues along the length 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: 22727595
• Report Number: 2124215-2025-53149
• Device Sequence Number: 8288491
• Product Code: NIO
• UDI-Device Identifier: 08714729392514
• UDI-Public: (01)08714729392514(17)270701(10)34345179
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74938047960130
• Device Catalogue Number: H74938047960130
• Device Lot Number: 0034345179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 09/01/2025; 11/09/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 08/29/2025; 09/29/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown