Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
18
Table 12. Summary of Subjects with Serious Adverse Events Related to
Device/Procedure by Dissection Type
Dissection Type
Number of
Subjects
Number of
Subjects with
Dissections and
SAEs Related to
Device/Procedure
SAE Summary
for Subjects with
Dissections
1
Dissection Rate (All Types)
55/443 (12.4%) 14/55 (25.5%)
Coronary vessel dissection
present on subjects treated
with OAD
52/443 (11.7%) 14/52 (26.9%)
Type: A 9/52 (17.3%) 3/14 (21.4%)
MI (2), in-stent
thrombus (1),
hypotension (1)
Type: B 22/52 (42.3%) 4/14 (28.6%)
MI (4); emergent
CABG treatment
(1)
Type: C 8/52 (15.4%)
2
1/14 (7.1%) MI (1)
Type: D 4/52 (7.7%) 3/14 (21.4%)
MI (3); stroke (1);
tamponade (1)
Type: E 1/52 (1.9%) 0/14 (0.0%)
Type: F 1/52 (1.9%) 1/14 (7.1%) MI (1)
Type: Not Analyzable 7/52 (13.5%) 2/14 (14.3%) MI (2); A-fib (1)
Coronary vessel dissection
present on subjects not treated
with OAD
1/443 (0.2%) 0/1 (0.0%)
Non-coronary vessel dissection
present on subjects treated
with OAD – Aortic Root
Dissections
2/443 (0.5%)
2
1/2 (50.0%) MI (1)
Non-coronary vessel dissection
present on subjects treated
with OAD – Aortic Cusp
Dissections
1/443 (0.2%) 0/1 (0.0%)
1 Some subjects had more than one SAE associated with the dissection event. In addition to MI,
the following events also occurred:
• Stroke (005-002)
• CABG (007-030)
• Thrombus (027-008)
• A-fib (009-026)
• Hypotension (015-006)
• Tamponade (018-003)
2 One subject (022-001) was noted by the Angiographic Core Laboratory to have both a Type C
dissection in the target vessel and a non-coronary aortic root dissection. Therefore, it is included
under both types of dissections. The SAE reported for this subject is included in the reporting of
SAEs in both associated columns.