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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Restenosis (4576)

Event Date 08/26/2021

Event Type  Injury  

Event Description

It was reported via journal article to review case reports of carotid computed tomography angiography (cta) after cobolt-based alloy carotid artery stenting to monitor for restenosis.This article looked at a newer option of using an ultra-high-resolution ct (uhrct) scanner system.The uhrct scanner system has a smaller detector element and focal spot as compared with conventional ct systems; it allows acquisition of images with higher spatial resolution in both in-plane and z-axis directions and other technical innovations that allow detailed vascular assessment with carotid artery stents.One case, with a 76-year-old symptomatic man with high-grade right carotid artery stenosis, underwent stent placement using carotid wallstent monorail.After 2 years, in-stent restenosis was suspected, and cta was performed using a uhrct scanner system.Curved planar reformation (cpr) image using model-based ir algorithm reconstruction method indicated in-stent restenosis and intimal formation.Digital subtraction angiography revealed in-stent restenosis and intimal formation, which further supported and validity of this cpr image.Two other patient cases were evaluated (along with a control case), and it was determined that the combination of the uhrct scanner system with model-based ir algorithm may play a significant role in evaluating in-stent restenosis and vessel patency in follow-up examination of patients treated with carotid artery stenting.Kayano, shingo, rt,phd.Carotid computed tomography angiography after cobalt-based alloy carotid artery stenting using ultra-high-resolution computed tomography with model-based iterative reconstruction.Radiology case reports 16 (2021) 3721-3728.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15547113
• MDR Text Key: 301234096
• Report Number: 2124215-2022-38237
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male