Device-Related Adverse Events and Modes of Failure in Renal Denervation Systems: Insights From the Food and Drug Administration Manufacturer and User Facility Device Experience (FDA MAUDE) Database Analysis

Abstract

Renal denervation (RDN) therapy has emerged as a device-based treatment option for patients with resistant hypertension. There are currently two Food and Drug Administration (FDA) approved RDN systems in the United States: the ParadiseR RDN system (Recor Medical, Palo Alto, California) and the Symplicity SpyralTM RDN system (Medtronic, Minneapolis, Minnesota). There are limited data on commonly reported adverse events and failure modes associated with these devices. Our objective is to assess the frequently reported adverse events and modes of failure for RDN therapy with the two FDA-approved devices by analyzing data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database was queried for the terms "renal denervation", "Symplicity Spyral", and "Paradise renal" for reports received by the FDA to yield a total of 61 results (44, 17, and 0 results, respectively), with the earliest event from November 9, 2016, to the latest on January 5, 2024. After adjusting for duplicates and excluding results unrelated to RDN therapy (n = 38), a total of 23 results pertaining to 13 cases were identified. All the events that resulted from the MAUDE database were Medtronic Symplicity SpyralTM-related. The most common complication reported was renal artery perforation or dissection (n = 7), of which five were intraprocedural vessel dissection and two were postprocedurally identified vessel perforation. Among the five intraprocedural vascular dissections, four were secondary to the guide wire. Other complications (n = 3) included intraprocedural bradycardia requiring atropine (n = 1) and postprocedural bleeding at the right groin access site (n = 2). Reported modes of failure for the RDN system were damage of the device component (n = 2) and device entrapment (n = 1). MAUDE database analysis to date has shown that the most common complication with the RDN system is renal artery dissection or perforation. RDN-related complications appear to be rare. These data provide valuable insight to both operators and manufacturers in further optimizing device performance and enhancing clinical outcomes. Further real-world data/clinical trials are needed to assess implications at a larger scale.