Abstract 17178: Adverse Events in Endovascular Robotic Assisted Procedures

Abstract

Introduction: Endovascular procedures are traditionally performed for a variety of indications. However, guidewire/catheter manipulation and hazardous radiation exposure are limitations to manual interventions. Thus, significant work has been done to develop robotic approaches to therapies. These devices have FDA clearance for performing procedures like cardiac arrhythmias, angioplasty, aneurysm repair and stenting etc. With the increasing usage of robotic assistance in endovascular procedures, it is essential to understand the adverse events that may occur. This study aims to provide an understanding of adverse events with currently available robotic systems. Methods: The analysis of adverse events is performed with the FDA MAUDE (Manufacturer and User Facility Device Experience) database. MAUDE database is a collection of reports on medical devices reported by manufacturers, distributors, users, volunteers. In case of occurrence of adverse events, FDA regulations requires that event to be reported for further investigation. Based on the impact of events on the patient’s outcome, the reported events were grouped into 3 categories death (patient death), injury (patient injury) or device malfunction. Results: A total of 71 different events were reported collectively for all the four robotic devices (Hansen Medical- 37, Corindus Inc.-27, Stereotaxis Inc.-5 & Catheter Robotics Inc.-2). The major adverse events included death and common injuries such as perforation, pseudo-aneurysm / blockage/ tamponade/ clot, blood pressure dropped or an effusion, or hemodynamic instability. The table summarizes the events by brand of system. Conclusions: While robotic approaches to intervention reflect a potentially useful means to improve outcomes of endovascular procedures by optimizing catheter manipulation with finer robotic motions or limiting radiation exposure, there are potentially significant risks. Whether these reflect higher or lower risk than traditional manual approaches requires randomized studies. Use of robotic technologies may present additional risks in light of potential malfunctions that occur from system errors that a human system may not be prone to. Future studies will be needed to better understand incremental benefit.