Table 1. Reports of the intra-orbital coronary atherectomy system failure in the MAUDE registry.
MAUDE: Manufacturer and User Facility Device Experience; RCA: right coronary artery; LAD: left anterior descending artery; LCX: left circumflex artery; LMCA: left main coronary artery.
| Total number of events | 547 |
| Target vessel | |
| LAD, n (%) | 172 (31.4%) |
| RCA, n (%) | 147 (26.9%) |
| LCX, n (%) | 118 (21.6%) |
| LMCA, n (%) | 35 (6.4%) |
| Other, n (%) | 14 (2.6%) |
| Insufficient/missing information, n (%) | 70 (12.8%) |
| Failure method | |
| Break or separation, n (%) | 221 (40.4%) |
| Entrapment, n (%) | 44 (8.0%) |
| Noise/higher rate than expected, n (%) | 9 (1.6%) |
| Flow lower than expected/not working, n (%) | 3 (0.5%) |
| Insufficient information, n (%) | 4 (0.7%) |
| None, n (%) | 233 (42.6%) |
| Clinical consequence | |
| Perforation, n (%) | 181 (33.0%) |
| Vessel dissection, n (%) | 63 (11.5%) |
| Device embedded in tissue, n (%) | 117 (21.3%) |
| Hematoma, n (%) | 6 (1%) |
| Thrombosis/myocardial infarction, n (%) | 13 (2.3%) |
| No reflow, n (%) | 28 (5%) |
| Arrhythmias, n (%) | 14 (2.5%) |
| None | 76 (39.4%) |
| Patient outcome | |
| Death, n (%) | 89 (16.3%) |
| No consequences, n (%) | 167 (30.5%) |
| Recovered, n (%) | 242 (44.2%) |
| Insufficient information, n (%) | 49 (9.0%) |