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PAE, primary adverse event; SADE, serious adverse device effect.
| Event | Classification | Severity | Causality | Outcome |
|---|---|---|---|---|
| Vascular pseudoaneurysm | PAE/SADE | Mild | Definitely procedure related | Resolved without sequelae |
| Pericarditis | PAE/SADE | Moderate | Definitely procedure related | Resolved without sequelae |
| Localized infection | SADE | Moderate | Probably procedure related | Resolved without sequelae |
