Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
17
Table 11 summarizes the first observed occurrence of the dissection or perforation as
assessed by the Angiographic Core Laboratory. Note: There is a possibility of dissection
or perforation following OAS use.
Table 11. Summary of Dissections and Perforations by Occurrence
Dissection First Identified
Subjects
N=52
Prior to OAS 8/52 (15.4%)
Pre-OAS/post-balloon 0/52 (0.0%)
Post-OAS 24/52 (46.2%)
Post-OAS #1/post-balloon/pre-OAS #2 1/52 (1.9%)
Post-OAS/pre-stent/post-balloon 7/52 (13.5%)
Post-stent 11/52 (21.2%)
Post-stent/post-balloon 0/52 (0.0%)
Not Analyzable 1/52 (1.9%)
Perforation First Identified Subjects N=8
Prior to OAS 0/8 (0.0%)
Pre-OAS/post-balloon 0/8 (0.0%)
Post-OAS 4/8 (50.0%)
Post-OAS/pre-stent/post-balloon 0/8 (0.0%)
Post-stent 4/8 (50.0%)
Post-stent/post-balloon 0/8 (0.0%)
Not Analyzable 0/8 (0.0%)
Table 12 summarizes serious clinical sequelae (i.e., death, MI, cardiac tamponade,
stroke/CVA, shock, atrial fibrillation, in-stent thrombosis, emergent CABG treatment, or
hypotension requiring additional medications) associated with dissections. Table 13
summarizes serious clinical sequelae associated with perforations. These tables also
include the identity of “non-coronary” structures that were dissected or perforated.