MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

Model Number	M001719050
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.A 10x31, 5.9f, 135cm carotid wallstent self-expanding stent and an enroute guidewire were selected for use in a verification of effectiveness study with physicians in simulated bench model.During deployment, it was noted that the stent sticking to the holding sleeve resulting in delay in stent release from the delivery system.The delivery system was manipulated, consequently, the stent became detached and stuck in the guidewire.The wire remains in the device and was removed with the system.There was no patient involvement.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.This device is recommended for use with a 0.014" (0.36mm) guidewire as per the ifu.The device was returned loaded on to the customer's guidewire and was in a deployed state.The investigator was unable to remove the guidewire from the device when fully deployed.The investigator retracted the stainless-steel shaft and put the device in a undeployed state and was able to remove the guidewire without any issues.A visual and tactile examination identified no issues with the catheter or delivery system.The device was returned with the stent fully deployed from the delivery system.The stent was not returned for analysis.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that device entrapment occurred.A 10x31,5.9f,135cm carotid wallstent self-expanding stent and an enroute guidewire were selected for use in a verification of effectiveness study with physicians in simulated bench model.During deployment, it was noted that the stent sticking to the holding sleeve resulting in delay in stent release from the delivery system.The delivery system was manipulated, consequently, the stent became detached and stuck in the guidewire.The wire remains in the device and was removed with the system.There was no patient involvement.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.This device is recommended for use with a 0.014" (0.36mm) guidewire as per the ifu.The device was returned loaded on to the customer's guidewire and was in a deployed state.The investigator was unable to remove the guidewire from the device when fully deployed.The investigator retracted the stainless-steel shaft and put the device in a undeployed state and was able to remove the guidewire without any issues.A visual and tactile examination identified no issues with the catheter or delivery system.The device was returned with the stent fully deployed from the delivery system.The stent was not returned for analysis.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that device entrapment occurred.A 10x31,5.9f,135cm carotid wallstent self-expanding stent and an enroute guidewire were selected for use in a verification of effectiveness study with physicians in simulated bench model.During deployment, it was noted that the stent sticking to the holding sleeve resulting in delay in stent release from the delivery system.The delivery system was manipulated, consequently, the stent became detached and stuck in the guidewire.The wire remains in the device and was removed with the system.There was no patient involvement.

• Brand Name: CAROTID WALLSTENT
• Common Device Name: STENT, CAROTID
• 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: 22462590
• Report Number: 2124215-2025-43644
• Device Sequence Number: 8826884
• Product Code: NIM
• UDI-Device Identifier: 08714729781127
• UDI-Public: (01)08714729781127(17)280826(10)35939215
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2025

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 Model Number: M001719050
• Device Catalogue Number: M001719050
• Device Lot Number: 0035939215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 11/07/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/13/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97434080-FA
• Patient Sequence Number: 1
• Patient Sex: Unknown