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

Model Number	M001719060
Medical Device Problem Codes	Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent was partially deployed and was difficult to reconstrain.The target lesion was located in the moderate to severely tortuous and moderately calcified carotid artery.A 10x37,5.9f,135cm carotid wallstent was selected for use.Access was gained via the femoral artery and the stent was positioned in the lesion.When the stent was deployed around 50%, it was noted that the t-connector and heart shape hub were touching.The stent was not able to be fully deployed due to this issue.It was noted that when the physician was pinning and pulling, it seemed like tension was lost in the hub area and a pop was heard.The stent was re-sheathed, except for a small part at the tip, and then removed from the patient.The procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that stent was partially deployed and was difficult to reconstrain.The target lesion was located in the moderate to severely tortuous and moderately calcified carotid artery.A 10x37,5.9f,135cm carotid wallstent was selected for use.Access was gained via the femoral artery and the stent was positioned in the lesion.When the stent was deployed around 50%, it was noted that the t-connector and heart shape hub were touching.The stent was not able to be fully deployed due to this issue.It was noted that when the physician was pinning and pulling, it seemed like tension was lost in the hub area and a pop was heard.The stent was re-sheathed, except for a small part at the tip, and then removed from the patient.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual and tactile inspection identified a complete outer sheath break located at approximately 1mm distal of the main t-body.Outer sheath damage was also noted approximately 185mm proximal from the distal tip.The device was returned with the stent partially deployed.The investigator was unable to deploy/reconstrain the stent.Due to the outer sheath break.

• 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: 22948241
• Report Number: 2124215-2025-60311
• Device Sequence Number: 9124579
• Product Code: NIM
• UDI-Device Identifier: 08714729781141
• UDI-Public: (01)08714729781141(17)270503(10)32774991
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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: M001719060
• Device Catalogue Number: M001719060
• Device Lot Number: 0032774991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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