Key result
Amplatzer occluders associate with ~730 reported adverse events, most commonly device embolization and cardiac erosion.
Why the study?
Although transcatheter atrial septal defect closure devices are effective and safe, concerns persist over cardiac erosion risk, and the FDA MAUDE database had not been reviewed since early reports covering the first decade of device experience.
What are the adverse events associated with Amplatzer Septal Occluder devices reported in the FDA MAUDE database from 2012 to 2018?
Observational (n=732)
What are the adverse events associated with Amplatzer Septal Occluder devices reported in the FDA MAUDE database from 2012 to 2018?
The frequency of erosion events with Amplatzer septal occluders remains low, though adverse events have increased recently, highlighting the need for ongoing surveillance.
Supports ongoing Amplatzer device surveillance in practice; leaves open precise incidence estimates from voluntary reports.
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.
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Bier et al. (2020) conducted an observational in Atrial septal defects (n=732). Amplatzer Septal Occluder, Cribriform Occluder, and PFO Occluder devices was evaluated on Adverse events and cardiac erosions. Analysis of the FDA MAUDE database from 2012 to 2018 identified 732 adverse event reports with Amplatzer occluders, most commonly device embolization (n=347) and cardiac erosion (n=90).
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