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Cumulative major adverse event rate
| Event | 30 days |
12 months |
||
|---|---|---|---|---|
| Incidence | Device related | Incidence | Device related | |
| Death | 1.9% (1/53) | 0% | 22.6% (12/53) | 0% |
| Implanted | 0% (0/36) | 22.2% (8/36) | ||
| Non-implanted | 6% (1/17) | 23.5% (4/17) | ||
| Myocardial infarction | 0% (0/53) | 0% | 4% (2/53) | 0% |
| Cardiac perforation | 0% (0/53) | 0% | 0% (0/53) | 0% |
| Device embolization | 0% (0/53) | 0% | 0% (0/53) | 0% |
| Surgery due to device | 0% (0/53) | 0% | 0% (0/53) | 0% |
| Overall MAE rate | 1.9% (1/53) | 0% | 26.4% (14/53) | 0% |
MAE, major adverse event.
