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

Catalog Number UNK-PLY-SPIDER

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

Patient Problems Embolism (1829); Hematoma (1884); Transient Ischemic Attack (2109); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 05/30/2019

Event Type  Injury  

Manufacturer Narrative

Doi: 10.1097/mca.0000000000000695.Prevalence and predictors of coronary artery disease in patients undergoing carotid artery stenting.Jakub sul¿enko, piotr paluszek, roman machnik, petr widimský, jirí jarkovský and piotr pieniazek.Age or date of birth: average age.Sex: majority gender.Date of event: event date = date of article publication.If information is provided in the future, a supplemental report will be issued.

Event Description

Introduction a relationship between carotid stenosis and coronary arterial disease (cad) is widely accepted; however, data on the exact prevalence of coronary disease in patients with severe carotid stenosis are lacking.Information on the prevalence and predictors of cad among these patients could impact diagnostic and treatment approaches.Aim the primary aim of this study was to determine the prevalence of significant cad among patients referred for carotid artery revascularization.The secondary objectives included characterizing the association between the level of advancement of carotid stenosis and the presence of cad, and between atherosclerotic risk factors and the presence of cad in patients with carotid stenosis, and also to determine whether there was a difference in the prevalence of cad between patients with symptomatic versus asymptomatic carotid stenosis.Patients and methods: we included 200 patients with severe carotid stenosis, of whom 77 (38.5%) had symptomatic stenosis.All patients underwent coronary angiography no more than 6 months before the scheduled carotid revascularization.Of the 200 total of patients, 192 underwent carotid stenting, six underwent carotid endarterectomy, and two were treated conservatively.Cad was defined as stenosis of at least 50% on recent coronary angiography or a history of previous percutaneous coronary intervention and/or coronary aortic bypass graft; the prevalence was 77.5% among our patients.There was no statistically significant difference in the prevalence of cad between patients with unilateral versus bilateral carotid stenosis or contralateral carotid occlusion.The difference in the severity of coronary disease, which was given by the syntax score, was not significant between these groups.Factors associated with the presence of cad were male sex,a history of smoking, and global or regional wall motion disorder on echocardiography.We did not find any significant difference in the prevalence of cad between patients with symptomatic versus asymptomatic carotid stenosis.Conclusion we observed a very high prevalence of concomitant cad in patients with severe carotid stenosis.The results of our study suggest that routine preprocedural screening for cad in patients with carotid artery stenosis could identify a large proportion of patients with silent cad; whether treatment for cad before carotid revascularization can prevent periprocedural myocardial infarction should be addressed in a randomized-controlled trial.200 patients with severe carotid stenosis were treated with moma ultra, spider fx, and chrisallo ideale with non-medtronic devices - aim of the study outlined above.The patients presented post procedure with asymptomatic plaque protrusion, treated with post dilation, ica dissection treated with stenting, embolization, ischemic stroke & puncture site bleeding.

• 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: 8774880
• MDR Text Key: 150560136
• Report Number: 2183870-2019-00364
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-PLY-SPIDER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/10/2019
• 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): Required Intervention
• Patient Age: 71 YR