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

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

Patient Problems Obstruction/Occlusion (2422); Ischemia Stroke (4418)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown.Used first day of the first month reported.Initial reporter facility name: (b)(6).Ichiro nakagawa1, md, phd; masashi kotsugi1, md; hun soo park1, md, phd; takanori furuta1, md; fumiya sato1, md; kaoru myouchin2, md; fumihiko nishimura1, md, phd; shuichi yamada1, md, phd; yasushi motoyama1, md, phd; hiroyuki nakase1, md, phd.Near-infrared spectroscopy carotid plaque characteristics and cerebral embolism in carotid artery stenting.Eurointervention 2021;17: 599-606.

Event Description

It was reported via journal article that embolic stroke and stent occlusion occurred.Abstract: this study aimed to determine whether high lipid core plaque (lcp) assessed by catheter-based near-infrared spectroscopy (nirs) is associated with ipsilateral cerebral embolism by diffusion-weighted magnetic resonance imaging during cas using a first-generation stent.Carotid stenosis magnetic resonance (mr) t1-weighted plaque signal intensity ratio (t1w-sir) followed by nirs assessment at the time of cas (using the carotid artery wallstent) was performed in 117 consecutive patients.Results: the maximum lipid core burden index (max-lcbi) at minimal luminal areas (mla; max- lcbimla) and the max-lcbi for any 4 mm segment in a target lesion defined as max-lcbiarea were significantly higher for the post-procedural new ipsilateral diffusion-weighted magnetic resonance imaging (dwi)-positive than negative patients (pless than 0.001 for all).There was a significant linear correlation between max-lcbiarea and the number of new emboli (r equals 0.544, p less than 0.0001).We also found that the second quantile (q2) of t1w-sirmla had a significantly higher max-lcbimla and a higher incidence of dwi positivity than q1 and q3 (p less than 0.001 for all).Furthermore, max-lcbimla appeared to distinguish between patients with and without postoperative new ipsilateral dwi positivity (auc 0.91, 95 percent ci: 0.86-0.96; ples than 0.0001).Conclusions: high lcp assessed by nirs is associated with cerebral embolism by diffusion-weighted imaging in cas using a first-generation stent.Findings from nirs-ivus and mri of carotid plaques.A) right symptomatic carotid stenosis in a 79-year-old man on tof image.B) plaque has slightly higher intensity on the t1-weighted image.C) nirs-ivus has a very high lcbi (961) at the mla segment.This patient presented with embolic stroke and stent occlusion after cas.D) left asymptomatic carotid stenosis in a 72-year-old man on tof image.E) plaque manifests as higher intensity than adjacent muscle on the t1-weighted image.F) nirs-ivus reveals very low lcbi (111) at the mla segment.Embolic events did not occur after cas in this patient.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15563247
• MDR Text Key: 301357850
• Report Number: 2124215-2022-40122
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• 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