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

Model Number	26665
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Ischemia Stroke (4418)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced stroke.On (b)(6) 2023, the patient underwent surgery and an 8x29, 5f, 135cm carotid wallstent was implanted in the carotid artery to regain blood flow.Three days later, the patient was discharged.However, the patient suffered another stroke two days after the discharged and was admitted back.It was then determined that the implanted stent failed, resulting in placement of two additional stents.No further patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that the patient experienced stroke.On (b)(6) 2023, the patient underwent surgery and an 8x29, 5f, 135cm carotid wallstent was implanted in the carotid artery to regain blood flow.Three days later, the patient was discharged.However, the patient suffered another stroke two days after the discharged and was admitted back.It was then determined that the implanted stent failed, resulting in placement of two additional stents.No further patient complications were reported.It was further reported that on (b)(6) 2023 the carotid wallstent was deployed from the distal cervical left internal carotid artery up to the carotid bulb and ended at the proximal portion of the left common carotid artery.There was mild post-stenting narrowing of the stent with suboptimal apposition against the wall.Therefore, a sterling balloon was inflated to supra nominal pressure for appropriate expansion of the stent.Later that night after the patient was discharged, the patient was found with acute onset of aphasia and right sided hemiplegia.He returned to the hospital and worked up for acute ischemic stroke.The nih score was 22.Ct angiogram and ct perfusion scan of the brain demonstrated in-stent occlusion with no filling of the cervical internal carotid artery, with tandem occlusion of the left middle cerebral artery.The ct perfusion scan of the brain demonstrated a large area of ischemic penumbra with a relatively small core infarct.Given the clinical and radiographic findings, the patient was recommended to go to the operating room for mechanical thrombectomy and revision of the left internal carotid artery stent.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.E1: initial reporter facility name: (b)(6).

• 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: 17316782
• Report Number: 2124215-2023-34703
• Device Sequence Number: 4070361
• Product Code: NIM
• UDI-Device Identifier: 08714729781202
• UDI-Public: 08714729781202
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/22/2025

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 Expiration Date: 05/23/2026
• Device Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0030583646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Male