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

Model Number	M001719060
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that stent elongation occurred, requiring placement of another stent.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.A 10x37,5.9f,135cm carotid wallstent was selected for treatment.However, during the procedure, stent elongation was noted through angiographic image.The stent was fully expanded and implanted, and the procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was in good condition post-procedure.
Event or Problem Description
It was reported that stent elongation occurred, requiring placement of another stent.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.A 10x37,5.9f,135cm carotid wallstent was selected for treatment.However, during the procedure, stent elongation was noted through angiographic image.The stent was fully expanded and implanted, and the procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
(b)(6).Investigation results: the device was discarded at the healthcare facility; therefore, product analysis could not be performed.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the carotid wallstent device confirmed that the event of stent material deformation is a known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific concludes the most probable root cause as adverse event related to patient condition.It was reported that stent elongation occurred, requiring placement of another stent.The event occurred due to the high degree of stenosis.The additional device was reported to have been required due to the procedural event experienced by the patient.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24500673
• Report Number: 2124215-2026-11798
• Device Sequence Number: 18609381
• Product Code: NIM
• UDI-Device Identifier: 08714729781141
• UDI-Public: (01)08714729781141(17)290407(10)37643761
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: M001719060
• Device Catalogue Number: M001719060
• Device Lot Number: 0037643761
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 10/07/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female