Performance of the Diamondback Coronary Orbital Atherectomy System: Insight From MAUDE Database
Journal of the Society for Cardiovascular Angiography & Interventions
The Diamondback 360 Coronary Orbital Artherectomy System (Cardiovascular Systems Inc., St Paul, MN, USA) is the first and only orbital atherectomy system approved by the US FDA for treatment of severely calcified lesions. While the device has proven to be safe in clinical trials, real-world data are minimal.
The MAUDE “ Manufacturer and User Facility Device Experience” database was quired for reports of Diamondback 360 Coronary from January 2019 to January 2022.
A total of 566 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 547 reports. The most common mode of failure was break or separation of a device part (40.4%, n=221) mainly due to break in the Viber wire (66.1%), Drive shaft (22.7%), or crown (12.2%). . The most common vessel associated with events was LAD (31.4%), followed by RCA (26.9%), LCX 21.6% and Left main (6.4%). The most common clinical adverse outcomes was perforation (33.0%, n=181) with 23.7% resulting in cardiac tamponade. Most perforation cases were treated by covered stent (44.2%), surgery (30.5%), stent (98%), and balloon angioplasty (9%). There were 89 events of death with 67% due to perforation (p=<0.0001).
This report intended to focus on modes of failures and adverse outcome due to orbital atherectomy. Device failure seems to be low and majority of the adverse outcome was related to operator error and less likely to device malfunction.
Alhusain R, Ahmed AK, Shaikheldin A, Hussein S, Dandu C, Chalek A, et al. [Abdelrahim AH, Zghouzi M]. Performance of the Diamondback coronary orbital atherectomy system: insight from MAUDE database. J Soc Cardiovasc Angiogr Interv. 2022 May-Jun;1(3 Suppl):100263. doi:10.1016/j.jscai.2022.100263.
SCAI 2022 Scientific Sessions, May 19-22, 2022, Atlanta, GA.