Table 1.
Melody® valve procedural adverse events
| U.S. prospective studies (N=248) | Registry and case series | MAUDE medical device reports | Case Reports | |
|---|---|---|---|---|
| Conduit rupture / tear | 8 (3.2%) | 41 | 1 | - |
| Access site complications | 5 (2.0%) | 13 | - | - |
| Guidewire PA perforation | 3 (1.2%) | 4 | - | - |
| Hemodynamic change | 3 (1.2%) | - | - | 2 |
| Coronary compression | 2 (0.8%) | 5 | 5 | 1 |
| Ventricular arrhythmia | 1 (0.4%) | 1 | - | - |
| Paravalvar leak | 1 (0.4%) | - | - | - |
| Malposition / embolization | - | 5 | 5 | 1 |
| Acute device failure | - | 3 | 4 | - |
| Complete heart block | - | 2 | - | 1 |
| PA obstruction | - | 1 | 2 | - |
| Inappropriate unsheathing | - | - | 2 | - |
| Aorto-pulmonary fistula | - | - | 2 | 1 |
| Major AE NOS | - | 19 | - | - |
| Peri-procedural mortality | 0 (0%) | 4 | 1 | - |
AE: Adverse event, NOS: not otherwise specified