| Device Type ID | 1041 |
| Device Name | Pulmonic Valved Conduit |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | MWH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1041 |
| Device | Pulmonic Valved Conduit |
| Product Code | MWH |
| Device Problems | |
|---|---|
Insufficient Information | 183 |
Gradient Increase | 58 |
Adverse Event Without Identified Device Or Use Problem | 43 |
Calcified | 22 |
Obstruction Of Flow | 14 |
Appropriate Term/Code Not Available | 10 |
Inadequacy Of Device Shape And/or Size | 10 |
Occlusion Within Device | 9 |
Device Operates Differently Than Expected | 9 |
Structural Problem | 4 |
Incomplete Coaptation | 3 |
Restricted Flow Rate | 2 |
Material Distortion | 2 |
Material Deformation | 2 |
Material Separation | 2 |
Patient-Device Incompatibility | 2 |
Material Integrity Problem | 2 |
Human-Device Interface Problem | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
No Apparent Adverse Event | 1 |
Perivalvular Leak | 1 |
Increase In Pressure | 1 |
Patient Device Interaction Problem | 1 |
Complete Blockage | 1 |
Unintended Movement | 1 |
Leak / Splash | 1 |
Biocompatibility | 1 |
Separation Problem | 1 |
Stretched | 1 |
Material Perforation | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 391 |