MAUDE Adverse Event Report: COVIDIEN SPIDER FX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

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

Patient Problem Death (1802)

Event Date 12/01/2016

Event Type  Death  

Manufacturer Narrative

Remote pre-procedural ischemic stroke as the greatest risk in carotid-stenting-associated stroke and death: a single center's experience.Mária ra¿iová 1, 2 *, lubomír ¿pak 1, ludmila farka¿ová international angiology 2017 august; 36(4):306-15 http://www.Minervamedica.It.Age/date of birth: average age.Sex: majority gender.Event date is literature article published date.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Journal: remote pre-procedural ischemic stroke as the greatest risk in carotid-stenting-associated stroke and death: a single center¿s experience.Event description: 502 patients were consecutively treated with cas with cerebral protection between june 20th, 2008 and december 31st, 2015, with a moma, cristallo ideale and spider fx.It is reported that 198 patients suffered a remote ischemic stroke, and 9 death occurred in the periprocedural period.Background: the goal of carotid artery stenting (cas) is to decrease the stroke risk in patients with carotid stenosis.This procedure carries an immediate risk of stroke and death and many patients do not benefit from it, especially asymptomatic patients.It is crucial to accurately select the patients who would benefit from carotid procedure, and to rule out those for whom the procedure might be hazardous.Remote ischemic stroke is a known risk factor for stroke recurrence during surgery.The aim of our study was to determine the periprocedural complication risk (within 30 days after cas) associated with carotid stenting (stroke, death) in patients with and without remote pre-procedural ischemic stroke, to analyze periprocedural risk in other specific patient subgroups treated with cas, and to determine the impact of observed variables on all-cause mortality during long-term follow-up.Methods: we conducted a retrospective review of prospectively collected data from all patients treated with protected cas between june 20, 2008 and december 31, 2015.Patient age, gender, type of carotid stenosis (symptomatic versus asymptomatic), side of stenosis (right or left carotid artery), type of cerebral protection (proximal versus distal), presence of comorbidities (remote ischemic pre-procedural ischemic stroke, coronary artery disease, diabetes mellitus, peripheral artery disease), previous ipsilateral carotid endarterectomy (cea), contralateral carotid occlusion (cco) and previous contralateral cas/cea were analyzed to identify higher cas risk and to determine the impact of these variables on all-cause mortality during follow-up.Survival data were obtained from the health care surveillance authority registry.Mean follow-up was 1054 days (interquartile range 547.3; 1454.8).Remote pre-procedural ischemic stroke was defined as any-territory ischemic stroke >6 months prior to cas.Results: primary periprocedural endpoint incidence (stroke/death) in 502 patients was 3.8% (n.=19) of all patients, 5.4% (n.=10) of symptomatic patients and 2.8% (n.=9) of asymptomatic patients.The risk of periprocedural stroke/death was 3.4 times higher in patients with (n.=198) compared to patients without remote ischemic stroke (n.=304) (6.6% versus 2.0% of patients without remote ischemic stroke; p=0.008).Periprocedural stroke/death in symptomatic patients (n.=186) was non-significantly higher in patients with remote ischemic stroke (n.=76) compared with patients without remote ischemic stroke (n.=110) (7.9% versus 3.6%; p=0.206).Asymptomatic patients with remote ischemic stroke (n.=122) had a 5.6-time-higher periprocedural risk of stroke/death compared with asymptomatic patients without remote ischemic stroke (n.=194) (5.7% versus 1.0%; p=0.014).Patients =75 years (n.=83) had a 3.0-time-higher periprocedural risk of stroke/death compared with younger patients (n.=419) (8.4% versus 2.9%; p=0.015); a non-significant increase of periprocedural stroke/death was found in both symptomatic (n.=35) and asymptomatic (n.=48) elderly patients (11.4% versus 4.0%, p=0.078; and 6.3% versus 2.4%, p=0.124, respectively).Increased periprocedural risk of stroke/death was not documented in other analyzed patient subgroups.During long-term follow-up, a 1.5-time higher mortality risk was found in patients with remote ischemic stroke compa red with patients without remote ischemic stroke in multivariable analysis; other patient subgroups (except older versus younger patients) did not differ in long-term mortality following carotid stenting.Conclusions: in our experience, all patients with remote pre-procedural any-territory ischemic stroke belong to risky subgroup for periprocedural stroke death after cas.All asymptomatic patients with remote ischemic stroke should not be treated with cas.Remote ischemic stroke increases all-cause mortality in long-term follow-up after carotid stenting.Patients aged =75 years also have increased risk of periprocedural stroke and death after cas.These factors should help us to be more selective when planning carotid procedures.

• Brand Name: SPIDER FX
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6766335
• MDR Text Key: 81779647
• Report Number: 2183870-2017-00330
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• 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: 07/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR