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

Model Number	M001719060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced allergic reaction post stent implantation.A 10x37,5.9f,135cm carotid wallstent was implanted in the patient.Post stent implantation, patient experienced systemic hives, welts, angioedema, and an anaphylactic reaction.The patient had been placed on many steroids and seen 3 allergists to date.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 09/25/2025 as the exact event date was not reported.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 09/25/2025 as the exact event date was not reported.Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that 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 review of the carotid wallstent device was completed and confirmed that the events of allergic reaction and edema were defined in the risk documentation.The event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that patient experienced allergic reaction post stent implantation.A 10x37,5.9f,135cm carotid wallstent was implanted in the patient.Post stent implantation, patient experienced systemic hives, welts, angioedema, and an anaphylactic reaction.The patient had been placed on many steroids and seen 3 allergists to date.

• 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: 24484123
• Report Number: 2124215-2026-11371
• Device Sequence Number: 12006904
• Product Code: NIM
• UDI-Device Identifier: 08714729781141
• UDI-Public: (01)08714729781141(17)280411(10)35049980
• 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
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M001719060
• Device Catalogue Number: M001719060
• Device Lot Number: 0035049980
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 10/11/2024
• 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: Other
• Patient Sex: Unknown