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

Model Number	M001719040
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	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received with the stent fully deployed from the delivery system.The stent was not returned for analysis.A visual and tactile inspection identified a complete outer sheath break located at approximately 1mm distal of the main t-body.No other issues were found with the catheter.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified with the device.
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in the non-tortuous and non-calcified carotid artery.A 10x24,5.9f,135cm carotid wallstent self-expanding was selected for use.During deployment of about 3/4 of the stent, it was noted that the shaft broke and partially separated.Eventually, the stent was able to be fully deployed and the whole delivery catheter was able to be pulled out.The stent was implanted and was not re-constrain.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: 21886746
• Report Number: 2124215-2025-21967
• Device Sequence Number: 8097985
• Product Code: NIM
• UDI-Device Identifier: 08714729781103
• UDI-Public: (01)08714729781103(17)280317(10)34853552
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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: M001719040
• Device Catalogue Number: M001719040
• Device Lot Number: 0034853552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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