Complications of Penumbra Indigo Aspiration Device in Pulmonary Embolism: Insights From MAUDE Database

Abstract

BackgroundThe Penumbra Indigo aspiration system (Penumbra Inc., Alameda, CA, USA) is a suction embolectomy device that was cleared by the Food and Drug Administration for use in acute pulmonary embolism (PE). While this device has proven to be safe in clinical trials, real-world data are minimal. MethodsThe “Manufacturer and User Facility Device Experience” MAUDE database was queried for reports of Penumbra indigo system from January 2020 to August 2021. ResultsA total of 2118 reports were found during the study period. After the exclusion of duplicate and incomplete reports as well as reports not related to PE, our final cohort included 67 reports related to Penumbra indigo device failure. The most common failure mode was Lightning unit malfunction (35.8%, n = 24) followed by rotating hemostasis valve malfunction (31.3%, n = 21). Three (4.5%) patients died; two (3%) from fatal pulmonary vessel perforation, and one from fatal right-sided heart failure. There was one case (1.5%) of pericardial effusion, while there were no cases of hemoptysis or blood transfusion. ConclusionThe overall number of reports in the MAUDE registry related to the Penumbra Indigo aspiration system is small (67 reports in 20 months). The most common reported failure mode was Lightning unit malfunction. These data serve to inform operators about potential issues when using the Penumbra Indigo thrombus aspiration system and identify areas on which to focus further device iteration.