Complications and Failure Modes of Stingray LP Balloon: Insights from the MAUDE Database
Presenter
Ramy Sedhom, M.D., Loma Linda University Medical Center, Loma Linda, CA
Ramy Sedhom, M.D.1, Michael S Megaly, M.D., FSCAI2, Magdi Zordok, M.D.3, M. Nicholas Burke, M.D.4, Babar B Basir, DO, FSCAI5, Stéphane Rinfret, M.D., FSCAI6, William J. Nicholson, M.D.7, Dimitrios Karmpaliotis, M.D., FSCAI8, Khaldoon Alaswad, M.D., FSCAI9 and Emmanouil S. Brilakis, MD, PhD, FSCAI4, (1)Loma Linda University Medical Center, Loma Linda, CA, (2)Henry Ford Hospital, Bossier City, LA, (3)Department of Medicine, Steward Carney Hospital, Boston, MA, (4)Minneapolis Heart Institute® - Abbott Northwestern Hospital, Minneapolis, MN, (5)Henry Ford Health System, Detroit, MI, (6)Georgia Heart Institute, Atlanta, GA, (7)Emory HealthCare, York, PA, (8)Atlantic Health Morristown Medical Center, Morristown , NJ, (9)Henry Ford Hospital, Detroit, MI
Keywords: Chronic Total Occlusion (CTO), Complex and High-risk Coronary Intervention (CHIP) and Coronary
Background
The Stingray LP balloon (Boston Scientific, Marlborough, MA) is frequently used to facilitate distal true lumen re-entry in case of subintimal guidewire entry during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). There is limited data on the failure modes of the Stingray LP balloon.
Methods
We investigated the Manufacturer and User Facility Device Experience (MAUDE) database for reports on Stingray LP failure from January 2016 to December 2020 (the device was approved in December 2015). The database was last accessed on January 3rd, 2021. The outcomes this study was the modes of failure and their clinical consequences.
Results
A total of 95 reports were found during the study period. After excluding duplicates and irrelevant reports (n=23), reports on the initial Stingray balloon (n=16), and Stingray wire reports (n=5), our final cohort included 51 reports. The most common mode of failure was balloon rupture after delivery (45%), followed by failure of the wire to pass through the catheter (15.7%), and shaft fracture (15.7%). Serious clinical consequences were rare with no injury to the patient in 96% of the reports and completed procedure in 87%. Coronary perforation and tamponade occurred in 1 report, emergency cardiac surgery was required in 1 report and no patients died.
Conclusions
Our study is the first to describe the modes of failure of Stingray LP balloon since its approval in 2015. We found that reports on Stingray LP failure were rare (51 over 5 years) with the most common one being was rupture after delivery. There were no significant clinical consequences in most cases.