Cardiac Erosions with the Amplatzer Septal Occluder: Adverse Events in the Manufacturer and User Facility Device Experience (MAUDE) Database since the 2012 FDA Review

Abstract

ABSTRACT Background: Transcatheter closure is the preferred treatment for atrial septal defects. The available devices are effective and safe though concerns persist over cardiac erosion risk. A review of the FDA Manufacturer and User Facility Device Experience (MAUDE) database has not been performed since early reports covering the first decade of device experience. Methods: The FDA MAUDE database was queried for adverse event (AE) reports from 2012 through 2018 involving the Amplatzer Septal Occluder (ASO), Cribriform Occluder (ACO) and PFO Occluder (PFO) devices (Abbott Vascular, Santa Clara, California). Device and event descriptions were analyzed based on report classification, device type and event description. The incidence of AEs was analyzed over time for all event types and devices. Results: There were 732 MAUDE reports describing 764 AEs. The majority of AEs involved the ASO, and the most common AE was device embolization (n = 347). Ninety erosion events were reported (ASO 83, ACO 6, and PFO 1) and 4 erosions were associated with death. The annual number of AE and erosion reports declined from 2012 to 2015 but increased in 2018. Five ASO sizes accounted for 60% of erosions with the 26 mm ASO device being most common. Conclusions: The overall frequency of erosion events in the MAUDE dataset remains low and consistent with prior studies. Adverse events and erosions declined from 2012 to 2015 but have increased in recent years, necessitating future review of this database to ensure that real-world device performance remains consistent with the safety profile demonstrated elsewhere.