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

Model Number	M001719050
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Restenosis (4576)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis occurred resulting to vessel occlusion.A 10x31, 5.9f, 135cm carotid wallstent self expanding was placed last (b)(6) 2024.In (b)(6) 2024, restenosis occurred resulting to vessel occlusion.A new stent was placed.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that restenosis occurred resulting to vessel occlusion.A 10x31,5.9f,135cm carotid wallstent self expanding was placed last (b)(6) 2024.In (b)(6) 2024, restenosis occurred resulting to vessel occlusion.A new stent was placed.There were no patient complications as a result of this event.It was further reported that the stent deployed in an hourglass shaped as confirmed in the photo.

• 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: 21929381
• Report Number: 2124215-2025-23845
• Device Sequence Number: 9073312
• Product Code: NIM
• UDI-Device Identifier: 08714729781127
• UDI-Public: (01)08714729781127(17)270813(10)33402822
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/07/2025

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: M001719050
• Device Catalogue Number: M001719050
• Device Lot Number: 0033402822
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 08/07/2025
• Date Device Manufactured: 02/12/2024
• 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; Other
• Patient Sex: Unknown