查看文章

Background: Aspiration thrombectomy devices, such as the AngioJet Solent Omni, have been approved by the US FDA for the treatment of thrombi in peripheral arterial disease, venous disease, and AV fistulas. However, real-world data on the most common modes of failure and complications associated with the AngioJet Solent Omni are unknown.

Methods: The MAUDE database was queried for reports of device failure and adverse events from 10/2012 to 12/2021.

Results: A total of 499 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 450 reports. The most common mode of failure was catheter breakage/kinking during suction thrombectomy with 137 reports (30%). The most common vessel associated with events was the superficial femoral artery or vein which occurred in 82 reports (18.2%). The most common adverse clinical outcome was embedding of a piece of the device in the patient which occurred in 7 reports (1.6%). There were 7 (1.6%) events of death reported with the use of the AngioJet.

Conclusions: AngioJet Solent Omni devices provide promising results; however it is important to evaluate device safety. It is associated with complications including device embedment, catheter breakage/kinking, and death which are driven by the patient's characteristics and risk factors.