Investigating the Complications and Causes of Failure of the AngioVac System: A Post-Marketing Surveillance From the MAUDE Database.

Background Aspiration thrombectomy devices, such as the AngioVac, allow the removal of thrombus, especially in patients with contraindications to anticoagulation use. The AngioVac was approved by the U.S. Food and Drug Administration to remove fresh, soft thrombi or emboli during extracorporeal bypass for up to six hours. Real-world data on the most common modes of failure and complications associated with the AngioVac are unavailable. Methods The Manufacturer and User Facility Device Experience database was queried for reports of the AngioVac device failure and adverse events from April 2013 to March 2022. Categorical variables were described as numbers, and all statistical calculations were performed with IBM SPSS Statistics, version 27.0 (IBM Corp., Armonk, NY). Results A total of 115 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 93 reports. The most common mode of failure for the AngioVac was physical damage of the device, with 13 reports (14%). The most common vessels associated with events were the superior vena cava and inferior vena cava, occurring in 23 reports (24.7%). The most common adverse clinical events were pulmonary embolism (PE), occurring in 33 reports (35.5%), and perforation, occurring in 16 reports (17.2%). Other less frequent adverse outcomes were arrhythmias, stroke, and foreign body device embedment. There were 45 deaths reported with the use of the AngioVac. Conclusions Aspiration thrombectomy devices provide promising efficacy; however, physicians should be aware of known adverse outcomes, even if they are infrequent. Based on this analysis, PE and vessel perforation were the most common adverse outcomes. Furthermore, the most common mode of failure was secondary to physical damage of the device.