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

Model Number	M001719030
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent partial deployment and shaft break occurred.The target lesion was located in the carotid artery.An 8x36, 5f, 135cm carotid wallstent was selected for treatment.During the procedure, when half of the stent was deployed, it was noted that the shaft fractured at the monorail port after a "snap" sound was heard.The stent was removed after being slowly resheathed, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned to our post market quality assurance laboratory.A visual and tactile inspection identified a break of the outer sheath located at approximately 1210mm distal of the main t-body.The device was received with the stent in the correct location on the device.There were no issues with the tip of the device.The investigator was unable to deploy the stent due to the separation of the outer sheath of the device, which confirmed the event.
Event or Problem Description
It was reported that stent partial deployment and shaft break occurred.The target lesion was located in the carotid artery.An 8x36, 5f, 135cm carotid wallstent was selected for treatment.During the procedure, when half of the stent was deployed, it was noted that the shaft fractured at the monorail port after a "snap" sound was heard.The stent was removed after being slowly resheathed, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the stent was placed in the transverse venous sinus.There was no visible stenosis, but there was a pressure gradient, so the neurosurgeon proceeded to treat.Additionally, the anatomy was normal, and no calcium was noted, but the cranial vault was placing some degree of external compression.

• 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: 21691727
• Report Number: 2124215-2025-18207
• Device Sequence Number: 8849269
• Product Code: NIM
• UDI-Device Identifier: 08714729781226
• UDI-Public: (01)08714729781226(17)280612(10)35476961
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/17/2025

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: 0035476961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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
• Patient Sex: Unknown