Table 1: Definitions for adverse event severity.

Severity Level

Definition

Examples

1. None

No harm, no change in condition, may have required monitoring to assess for potential change in condition with no intervention indicated.

Balloon rupture
Equipment problem

2. Minor

Transient change in condition, not life-threatening, condition returns to baseline, required monitoring, required minor intervention such as holding a medication, or obtaining laboratory test.

Groin hematoma
Self-resolving arrhythmia

3. Moderate

Transient change in condition may be life-threatening if not treated, condition returns to baseline, required monitoring, required intervention such as reversal agent, additional medication, transfer to the intensive care unit for monitoring, or moderate transcatheter intervention to correct condition.

Unstable arrhythmia with preserved blood pressure requiring intervention
Vascular damage not life-threatening but requiring intervention

4. Major

Change in condition, life-threatening if not treated, change in condition may be permanent, may have required an intensive care unit admission or emergent readmit to hospital, may have required invasive monitoring, required interventions such as electrical cardioversion or unanticipated intubation or required major invasive procedures or transcatheter interventions to correct condition.

Event requiring cardiopulmonary resuscitation
Event leading to surgery or repeat catheterization
Stroke

5. Catastrophic

Any death, and emergent surgery or heart lung bypass support (ECMO) to prevent death with failure to wean from bypass support.

Event resulting in death