Abstract TP154: Device Malfunction Related Adverse Events in Patients Undergoing Carotid Angioplasty and Stent Placement: An analysis of the FDA Manufacturer and User Facility Device Experience Database
Background: Carotid angioplasty and stenting (CAS) has emerged as a less invasive treatment alternative to carotid endarterectomy and the frequency of CAS is increasing. A large scale analysis of the device malfunction related adverse events associated with carotid stenting has not previously been undertaken.
Methods: Adverse events reported to the United States FDA Manufacturer and User Facility Device Experience were analyzed. This data includes voluntary reporting of adverse events related to medical device use. We analyzed the characteristics of device related adverse events which included hypotension, bradycardia, hyperperfusion syndrome, transient ischemic attack (TIA), stroke, carotid artery spasm, myocardial infarction, cardiac arrest, and vessel dissection from 2010 to 2012 in the United States.
Results: From 2010 to 2012, there were a total of 1211 adverse events reported to the FDA related to CAS. The most common adverse event was stroke, which represented 39.3% of the clinical adverse events. Adverse device deployment was most commonly affected by intraprocedural malfunction of the stent, which occurred in 22.0% of reported events, followed by incomplete coverage by the stent requiring a second stent, 15.5% of events. In addition, vessel tortuosity, 11.0% of events, and vessel calcification, 4.5%, played a role in adversely affecting stent deployment. The stents most commonly involved in intraprocedural malfunction were the Carotid Wall Monorail stent and the Acculink carotid stent, which represented 29.5% and 30.8% of the failures respectively. The clinical events associated with device malfunction were stroke (n=464), TIA (n=186), carotid artery spasm (n=30), and carotid dissection (n=8).
Conclusions: This is the first large scale study to report on the device malfunction related adverse events associated with carotid stent placement. The most common device complication relates to intraprocedural malfunction of the stent, which represents 22% of reported failures.
- © 2012 by American Heart Association, Inc.