{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T01:38:12Z","timestamp":1788485892587,"version":"build-2803163510"},"reference-count":14,"publisher":"Michigan State University College of Osteopathic Medicine Statewide Campus System","issue":"1","license":[{"start":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T00:00:00Z","timestamp":1787875200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:sec id=\"introduction\">\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Renal denervation (RDN) has re-emerged as an adjunctive therapy for uncontrolled hypertension following recent U.S. Food and Drug Administration (FDA) approvals of ultrasound- and radiofrequency-based systems. Although randomized trials report a favorable safety profile, post-marketing data may reveal additional safety signals in real-world settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"methods\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We performed a retrospective descriptive observational study of reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database from inception through December 22, 2025, which represented the final date of data extraction. Reports were identified using product code \u201cQYI\u201d and brand names \u201cParadise\u201d and \u201cSymplicity Spyral.\u201d Eligible reports describing RDN for hypertension management were manually reviewed and categorized as vascular, device-related, hemodynamic\/arrhythmic, neurologic, or other events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"results\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 33 reports were identified, including 19\/33 (57.6%) involving the Paradise system and 14\/33 (42.4%) involving the Symplicity Spyral system. Vascular complications were the most frequently reported events, accounting for 15\/33 reports (45.5%), including renal artery dissection (5\/33, 15.2%), thrombosis (3\/33, 9.1%), vasospasm (3\/33, 9.1%), pseudoaneurysm (2\/33, 6.1%), renal hematoma (1\/33, 3.0%), and acute limb ischemia (1\/33, 3.0%). Device-related events accounted for 10\/33 reports (30.3%), most commonly expired catheter use (4\/33, 12.1%) and catheter or component malfunction (6\/33, 18.2%). Hemodynamic\/arrhythmic events occurred in 4\/33 reports (12.1%), neurologic events in 2\/33 (6.1%), and other events accounted for 2\/33 reports (6.1%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"conclusions\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this descriptive MAUDE analysis, RDN was associated with uncommon but clinically relevant vascular and device-related adverse events in real-world practice. These findings support continued post-marketing surveillance as use of RDN expands. Interpretation is limited by the passive nature of MAUDE reporting, including underreporting, incomplete data, and the inability to determine incidence or causality.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.51894\/001c.168160","type":"journal-article","created":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T16:05:21Z","timestamp":1787846721000},"source":"Crossref","is-referenced-by-count":1,"title":["Device and Patient-Related Complications of Renal Denervation for Uncontrolled Hypertension: A Post-Marketing Analysis of the FDA MAUDE Database"],"prefix":"10.51894","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-4015-1903","authenticated-orcid":true,"given":"Sai Tharun Reddy","family":"Gopannagari","sequence":"first","affiliation":[{"name":"Garden City Hospital, Michigan, USA","department":["Department of Internal Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kesava Manikanta","family":"Achuta","sequence":"additional","affiliation":[{"name":"Garden City Hospital, Michigan, USA","department":["Department of Internal Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Divya","family":"Ganisetti","sequence":"additional","affiliation":[{"name":"Atal Bihari Vajpayee Institute of Medical Sciences & Dr Ram Manohar Lohia Hospital, New Delhi, India","department":["Department of Internal Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shravya","family":"Pingili","sequence":"additional","affiliation":[{"name":"University of Central Florida\/ HCA Florida Ocala Hospital, Florida, USA","department":["Department of Internal Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Towfiqul","family":"Chowdhury","sequence":"additional","affiliation":[{"name":"Garden City Hospital, Michigan, USA","department":["Department of Nephrology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chadi","family":"Saad","sequence":"additional","affiliation":[{"name":"Garden City Hospital, Michigan, USA","department":["Department of Nephrology"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"29343","published-online":{"date-parts":[[2026,8,28]]},"reference":[{"issue":"8","key":"ref1","doi-asserted-by":"publisher","first-page":"651","DOI":"10.1001\/jama.2023.0713","article-title":"Endovascular ultrasound renal denervation to treat hypertension: the RADIANCE II randomized clinical trial","volume":"329","author":"M. Azizi","year":"2023","journal-title":"JAMA"},{"issue":"10293","key":"ref2","doi-asserted-by":"publisher","first-page":"2476","DOI":"10.1016\/S0140-6736(21)00788-1","article-title":"Ultrasound renal denervation for hypertension resistant to a triple medication pill: RADIANCE-HTN TRIO, a randomised, multicentre, single-blind, sham-controlled trial","volume":"397","author":"M. Azizi","year":"2021","journal-title":"Lancet"},{"issue":"11","key":"ref3","doi-asserted-by":"publisher","first-page":"e96770","DOI":"10.7759\/cureus.96770","article-title":"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","volume":"17","author":"M. Jasti","year":"2025","journal-title":"Cureus"},{"issue":"1","key":"ref4","doi-asserted-by":"publisher","first-page":"89","DOI":"10.4244\/EIJ-D-19-00902","article-title":"Review and meta-analysis of renal artery damage following percutaneous renal denervation with radiofrequency renal artery ablation","volume":"16","author":"R. R. Townsend","year":"2020","journal-title":"EuroIntervention"},{"issue":"11","key":"ref5","doi-asserted-by":"publisher","first-page":"CD011499","DOI":"10.1002\/14651858.CD011499.pub3","article-title":"Renal denervation for resistant hypertension","volume":"11","author":"A. Pisano","year":"2021","journal-title":"Cochrane Database Syst Rev"},{"issue":"1","key":"ref6","doi-asserted-by":"publisher","first-page":"61","DOI":"10.2174\/1573402115666191011111402","article-title":"Resistant hypertension: novel insights","volume":"16","author":"G. Lamirault","year":"2020","journal-title":"Curr Hypertens Rev"},{"issue":"8","key":"ref7","doi-asserted-by":"publisher","first-page":"1951","DOI":"10.3390\/biomedicines13081951","article-title":"Safety and efficacy of renal denervation for the treatment of resistant hypertension in patients with chronic kidney disease: a narrative review of the literature","volume":"13","author":"P. Iliakis","year":"2025","journal-title":"Biomedicines"},{"issue":"12","key":"ref8","doi-asserted-by":"publisher","first-page":"1874","DOI":"10.1097\/HJH.0000000000003480","article-title":"2023 ESH Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension","volume":"41","author":"G. Mancia","year":"2023","journal-title":"J Hypertens"},{"issue":"10","key":"ref9","doi-asserted-by":"publisher","first-page":"e135","DOI":"10.1161\/HYP.0000000000000240","article-title":"Renal denervation for the treatment of hypertension: a scientific statement from the American Heart Association","volume":"81","author":"J. L. Cluett","year":"2024","journal-title":"Hypertension"},{"issue":"10333","key":"ref10","doi-asserted-by":"publisher","first-page":"1401","DOI":"10.1016\/S0140-6736(22)00455-X","article-title":"Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs: SPYRAL HTN-ON MED, a randomised, sham-controlled trial","volume":"399","author":"F. Mahfoud","year":"2022","journal-title":"Lancet"},{"issue":"5","key":"ref11","doi-asserted-by":"publisher","first-page":"464","DOI":"10.1001\/jamacardio.2023.0338","article-title":"Patient-level pooled analysis of ultrasound renal denervation in the sham-controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO trials","volume":"8","author":"A. J. Kirtane","year":"2023","journal-title":"JAMA Cardiol"},{"key":"ref12","article-title":"Manufacturer and User Facility Device Experience (MAUDE) Database","author":"U.S. Food and Drug Administration"},{"issue":"20","key":"ref13","doi-asserted-by":"publisher","first-page":"1599","DOI":"10.1161\/CIRCULATIONAHA.124.069709","article-title":"Effects of catheter-based renal denervation in hypertension: a systematic review and meta-analysis","volume":"150","author":"D. Vukadinovic","year":"2024","journal-title":"Circulation"},{"issue":"10137","key":"ref14","doi-asserted-by":"publisher","first-page":"2335","DOI":"10.1016\/S0140-6736(18)31082-1","article-title":"Endovascular ultrasound renal denervation to treat hypertension: RADIANCE-HTN SOLO, a multicentre, international, single-blind, randomised, sham-controlled trial","volume":"391","author":"M. Azizi","year":"2018","journal-title":"Lancet"}],"container-title":["Spartan Medical Research Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/smrj.scholasticahq.com\/article\/168160-device-and-patient-related-complications-of-renal-denervation-for-uncontrolled-hypertension-a-post-marketing-analysis-of-the-fda-maude-database","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T16:05:17Z","timestamp":1788019517000},"score":1,"resource":{"primary":{"URL":"https:\/\/smrj.scholasticahq.com\/article\/168160-device-and-patient-related-complications-of-renal-denervation-for-uncontrolled-hypertension-a-post-marketing-analysis-of-the-fda-maude-database"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,28]]},"references-count":14,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026]]}},"URL":"https:\/\/doi.org\/10.51894\/001c.168160","relation":{},"ISSN":["2474-7629"],"issn-type":[{"value":"2474-7629","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,28]]}}}