Definition: These Devices Are Intended To Replace A Patient's Pulmonary Heart Valve. They Are Different From The Classified Device (heart Valves) In That They Are Placed Percutaneously And Do Not Require Open Chest Surgery Or A Cardiotomy For Placement.
| Device Type ID | 1057 |
| Device Name | Pulmonary Valve Prosthesis 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 HDE Medical Device |
| Product Code | NPV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1057 |
| Device | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Product Code | NPV |
| Device Problems | |
|---|---|
Fracture | 78 |
Insufficient Information | 77 |
Gradient Increase | 67 |
Adverse Event Without Identified Device Or Use Problem | 58 |
Valve | 33 |
Malposition Of Device | 22 |
Perivalvular Leak | 20 |
Obstruction Of Flow | 16 |
Device Dislodged Or Dislocated | 13 |
Migration Or Expulsion Of Device | 12 |
Calcified | 9 |
Occlusion Within Device | 9 |
Incomplete Coaptation | 9 |
Appropriate Term/Code Not Available | 6 |
Material Rupture | 5 |
Positioning Problem | 3 |
Torn Material | 3 |
Complete Blockage | 3 |
Material Fragmentation | 3 |
Migration | 3 |
Inflation Problem | 2 |
Bent | 2 |
Activation Failure Including Expansion Failures | 2 |
Off-Label Use | 2 |
Partial Blockage | 2 |
Leak / Splash | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Fluid Leak | 2 |
Material Perforation | 1 |
Split | 1 |
Naturally Worn | 1 |
Entrapment Of Device | 1 |
Material Distortion | 1 |
Unintended Movement | 1 |
Patient Device Interaction Problem | 1 |
Balloon | 1 |
Increase In Pressure | 1 |
Material Split, Cut Or Torn | 1 |
Heart Valve Leaflet | 1 |
Catheter | 1 |
No Apparent Adverse Event | 1 |
Structural Problem | 1 |
Material Disintegration | 1 |
Difficult To Remove | 1 |
Patient-Device Incompatibility | 1 |
Device Operates Differently Than Expected | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 484 |