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

Model Number	M001719030
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became stuck upon removal.An 8mm x 36mm, 5f, 135cm carotid wallstent? monorail? endoprosthesis self-expanding stent was selected for treatment.However, after the stent was deployed, it was noted that the device became stuck on the guidewire upon removal.The physician had to remove the entire system.The procedure was completed with this device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the device became stuck upon removal.An 8mm x 36mm, 5f, 135cm carotid wallstent? monorail? endoprosthesis self-expanding stent was selected for treatment.However, after the stent was deployed, it was noted that the device became stuck on the guidewire upon removal.The physician had to remove the entire system.The procedure was completed with this device.There were no patient complications as a result of this event.

• 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: 22733633
• Report Number: 2124215-2025-52111
• Device Sequence Number: 15558271
• Product Code: NIM
• UDI-Device Identifier: 08714729781226
• UDI-Public: (01)08714729781226(17)280710(10)35589532
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 09/04/2025

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: M001719030
• Device Catalogue Number: M001719030
• Device Lot Number: 0035589532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/04/2025
• Date Device Manufactured: 01/09/2025
• 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 Age: 33 YR
• Patient Sex: Male