Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
19
Table 13. Summary of Subjects with Serious Adverse Events Related to
Device/Procedure by Perforation Type
Perforation Type
Number of
Subjects
Number of Subjects
with Perforations and
SAEs Related to
Device/Procedure
SAE Summary
for Subjects
with
Perforations
1
Perforation Rate (All Types)
9/443 (2.0%) 7/9 (77.8%)
Coronary vessel perforation
present on subjects treated
with OAD
8/443 (1.8%) 6/8 (75.0%)
Type: I 0/8 (0.0%) 0/6 (0.0%)
Type: II 2/8 (25.0%) 2/6 (33.3%)
MI (1);
tamponade (1);
stroke (1)
Type: III 5/8 (62.5%) 3/6 (50.0%)
Cardiac death
(2); MI (2);
tamponade (2);
shock (1)
Type: Cavity spilling 0/8 (0.0%) 0/6 (0.0%)
Type: Not Analyzable 1/8 (12.5%) 1/6 (16.7%)
MI (1); emergent
CABG treatment
+ A-fib (1)
Non-coronary vessel
perforation present on
subjects treated with OAD –
Right ventricle perforation
1/443 (0.2%) 1/1 (100%) Tamponade (1)
1
Some subjects may have had more than one SAE associated with the perforation event.
• Shock (044-003),
• Tamponade (007-015, 024-019, 009-018, 015-004)
• A-fib & CABG (009-044)
• Stroke (037-002)