Catalog Number UNK_NEU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Stroke/CVA (1770); Transient Ischemic Attack (2109)
|
Event Date 11/21/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
This is the 5th of 6 reports.Subject device is not available.
|
|
Event Description
|
This article retrospectively evaluate the safety and efficacy of the wingspan device for the treatment of symptomatic intracranial atherosclerotic stenosis (icas).A total of 50 patients (mean age 64.8 ±11.5 years, 39 women and 11 men) fulfilling the inclusion criteria received wingspan stenting in order to treat arterial stenosis between january 2013 and december 2015 were included in the study group.All patients underwent mri to audit any complications during the early follow-up period.Mean stenosis pre-stenting was 76.5 ±13.1% and post-stenting residual stenosis was 19.8 ±13.8%.The overall 30-day rate of procedure-related complications was 6.0% (3/50).Over a median or mean follow-up period which ranged from 1 to 15 months, there were recurrent transient ischemic attack (tia) or stroke that occured in the territory of the stented artery in two of three patients.
|
|
Manufacturer Narrative
|
A review of the device history record could not be performed because the lot number was not reported.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Information from the complaint indicated that, out of the 50 patients who underwent wingspan stenting as part of this clinical study, recurrent transient ischemic attack (tia) or stroke occurred in the territory of the stented artery in two of three patients.The reported patient tia and stroke are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications has been assigned to this event.
|
|
Event Description
|
This article retrospectively evaluate the safety and efficacy of the wingspan device for the treatment of symptomatic intracranial atherosclerotic stenosis (icas).A total of 50 patients (mean age 64.8 ±11.5 years, 39 women and 11 men) fulfilling the inclusion criteria received wingspan stenting in order to treat arterial stenosis between january 2013 and december 2015 were included in the study group.All patients underwent mri to audit any complications during the early follow-up period.Mean stenosis pre-stenting was 76.5 ±13.1% and post-stenting residual stenosis was 19.8 ±13.8%.The overall 30-day rate of procedure-related complications was 6.0% (3/50).Over a median or mean follow-up period which ranged from 1 to 15 months, there were recurrent transient ischemic attack (tia) or stroke that occured in the territory of the stented artery in two of three patients.
|
|
Search Alerts/Recalls
|