Table 4.
Serious adverse events (not including MAEs) observed within 30 days and relation to the FlowTriever System
| Preferred MedDRA term | Device‐related? | Number of occurrences |
|---|---|---|
| Anemia | No | 1 |
| Bradycardia | No | 1 |
| Cardiac failure | No | 1 |
| Cerebrovascular accident | No | 1 |
| Deep vein thrombosis | No | 1 |
| Hemoptysis | No | 1 |
| Hypotension | No | 1 |
| Hypovolemic shock | No | 1 |
| Intestinal perforation | No | 1 |
| Retroperitoneal hematoma | No | 1 |
| Shock hemorrhagic | No | 1 |
| Ventricular tachycardia | No | 1 |
Note: These events do not include the three MAEs reported in the primary endpoint results, all of which were also SAEs.
Abbreviations: MAE, major adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event.