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 04/01/2010

Event Type  Death  

Manufacturer Narrative

Journal of the american college of cardiology 2010 vol.55(6) title: proximal endovascular occlusion for carotid artery stenting authors: stabile, e; salemme, l; sorropago, g; tesorio, t; nammas, w; miranda, m; popusoi, g; cioppa, a; ambrosini, v; cota, l; petroni, g; pietra, gd; ausania, a; fontanelli, a; biamino, g; rubino, p [clinical research] title: proximal embolic protection author: white, cj [editorial comment].

Event Description

The 1300 patients were enrolled to the study.During in-hospital stay, 2 patients died due to cardiovascular reasons: 1 patient had a pulmonary edema 4 hrs after the procedure and died due to ventricular fibrillation, and the other patient experienced cardiac arrest the day after the procedure.This patient had an acute coronary syndrome 4 h after the procedure because of an acute occlusion of the left anterior descending artery that was treated with a percutaneous coronary intervention.One patient died due to a hemorrhagic stroke that occurred 4 h after the procedure.Another 2 patients died due to non cardiovascular reasons: 1 because of multi organ failure triggered by post-procedural acute renal failure and 1 because of subarachnoid bleeding probably caused by anti coagulation.During in-hospital stay, 5 patients had a minor stroke and 6 patients had a major, nonfatal stroke.The cumulative in-hospital incidence of death and stroke was 1.15%.During the 30-day follow-up period, 2 additional patients died.One patient died due to a drug-resistant pneumonia, and the other patient died due to a contrast-induced nephropathy that resulted in acute renal failure.During the 30-day follow-up period, 1 additional patient had a minor stroke; the patient presented with transient monocular blindness, and a computed tomography scan showed the presence of a new ischemic lesion in the visual cortex.Objectives: this single-center registry presents the results of proximal endovascular occlusion (peo) use in an unselected patient population.Background: in published multicenter registries, the use of peo for carotid artery stenting (cas) has been demonstrated to be safe and efficient in patient populations selected for anatomical and/or clinical conditions.Methods: from july 2004 to may 2009, 1,300 patients underwent cas using peo.Patients received an independent neurological assessment before the procedure and 1 h, 24 h, and 30 days after the procedure.Results: procedural success was achieved in 99.7% of patients.In hospital, major adverse cardiac or cerebrovascular events included 5 deaths (0.38%), 6 major strokes (0.46%), 5 minor strokes (0.38%), and no acute myocardial infarction.At 30 days of follow-up, 2 additional patients died (0.15%), and 1 patient had a minor stroke (0.07%).The 30-day stroke and death incidence was 1.38% (n ¿ 19).Symptomatic patients presented a higher 30-day stroke and death incidence when compared with asymptomatic patients (3.04% vs.0.82%; p ¿ 0.05).No significant difference in 30-day stroke and death rate was observed between patients at high (1.88%; n ¿ 12) and average surgical risk (1.07; n ¿ 7) (p ¿ ns).Operator experience, symptomatic status, and hypertension were found to be independent predictors of adverse events.Conclusions: the use of peo for cas is safe and effective in an unselected patient population.Anatomical and/or clinical conditions of high surgical risk were not associated with an increased rate of adverse events.

Manufacturer Narrative

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.

• 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: 6383740
• MDR Text Key: 69252541
• Report Number: 2183870-2017-00113
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• 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: 02/07/2017
• 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: 70 YR