Definition: These Devices Are Intended To Replace A Patient's Mitral Heart Valve. They Are Different From The Classified Device (heart Valves) In That They Are Placed Percutaniously And Do Not Require Open Chest Surgery Or A Cardiotomy For Placement.
| Device Type ID | 1056 |
| Device Name | Prosthesis, Mitral Valve, Percutaneously Delivered |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NPU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1056 |
| Device | Prosthesis, Mitral Valve, Percutaneously Delivered |
| Product Code | NPU |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Valve | 25 |
Adverse Event Without Identified Device Or Use Problem | 10 |
Catheter | 10 |
Perivalvular Leak | 8 |
Incomplete Coaptation | 6 |
Malposition Of Device | 6 |
Difficult To Position | 3 |
Leak / Splash | 3 |
Device Dislodged Or Dislocated | 3 |
Migration Or Expulsion Of Device | 2 |
Insufficient Information | 2 |
Fluid Leak | 1 |
Device Slipped | 1 |
Torn Material | 1 |
Material Rupture | 1 |
Difficult To Remove | 1 |
Leaflet | 1 |
Heart Valve Leaflet | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 86 |