Document Type
Conference Proceeding
Publication Date
5-1-2026
Abstract
Background: Renal denervation (RDN) has re-emerged as an adjunctive therapy for resistant hypertension following recent FDA approvals of ultrasound- and radiofrequency-based systems. While contemporary randomized trials report a favorable safety profile, real-world post-marketing data may capture a broader spectrum of complications. Methods: We queried the FDA Manufacturer and User Facility Device Experience (MAUDE) database from inception through December 22, 2025, using product code ‘QYI’ and brand names ‘Paradise’ (Recor Medical) and ‘Symplicity Spyral’ (Medtronic). Reports describing RDN procedures for resistant hypertension were included. Events were manually reviewed and categorized as vascular, device-related, hemodynamic/arrhythmic, neurologic, or other. When multiple events occurred in a single patient, the primary complication was used for classification, with secondary events described separately. Results: A total of 33 reports were identified, comprising 19 involving the Paradise system and 14 involving the Symplicity Spyral system. Vascular complications were the most frequently reported events (15/33), including renal artery dissection (5 cases), thrombosis (3 cases), vasospasm (3 cases), pseudoaneurysm (2 cases), renal hematoma (1 case), and acute limb ischemia (1 case). Device-related events accounted for 10 reports, most commonly involving expired catheter use (4 cases) and catheter or component malfunction (6 cases). Hemodynamic or arrhythmic events (4 cases) included bradycardia and one episode of transient asystole. Neurologic events were uncommon (1 case). Conclusions: Post marketing surveillance data reveal that RDN procedures are associated with infrequent but clinically relevant vascular and device-related complications in real-world practice. These findings support evidence from randomized trial data and highlight the importance of continued surveillance and procedural caution.
Recommended Citation
Gopannagari STR, Achuta KM, Ganisetti D, Chowdhury T, Saad C. Device and patient-related complications of renal denervation for resistant hypertension: a post-marketing analysis of the FDA MAUDE database. Presented at: American College of Physicians Michigan Chapter and Society of Hospital Medicine Michigan Chapter 2026 Resident and Medical Student Day; 2026 May 1; Troy, MI. Available from:https://www.acponline.org/sites/default/files/images/about_acp/chapters/mi/2026_MI-ACP_SHM-MI_RMSD_Abstracts_Residents_FINAL.pdf
Comments
American College of Physicians Michigan Chapter and Society of Hospital Medicine Michigan Chapter 2026 Resident and Medical Student Day, May 1, 2026, Troy, MI