| Device Type ID | 1013 |
| Device Name | Heart-valve, Mechanical |
| 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 | LWQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1013 |
| Device | Heart-valve, Mechanical |
| Product Code | LWQ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Insufficient Information | 300 |
Adverse Event Without Identified Device Or Use Problem | 283 |
Obstruction Of Flow | 60 |
Perivalvular Leak | 58 |
Incomplete Coaptation | 47 |
Inadequacy Of Device Shape And/or Size | 46 |
Gradient Increase | 45 |
Appropriate Term/Code Not Available | 44 |
Fracture | 29 |
Device Dislodged Or Dislocated | 28 |
Mechanical Jam | 27 |
Leak / Splash | 17 |
Interference | 12 |
Device Operates Differently Than Expected | 10 |
Microbial Contamination Of Device | 10 |
Break | 10 |
Material Fragmentation | 8 |
Device Remains Implanted | 6 |
Material Too Rigid Or Stiff | 6 |
Detachment Of Device Or Device Component | 6 |
No Apparent Adverse Event | 6 |
Difficult To Open Or Close | 6 |
Structural Problem | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
Detachment Of Device Component | 5 |
Mechanical Problem | 4 |
Contamination During Use | 4 |
Calcified | 4 |
Patient-Device Incompatibility | 4 |
Partial Blockage | 3 |
Material Separation | 3 |
Device Handling Problem | 3 |
Patient Device Interaction Problem | 2 |
Inadequate Or Insufficient Training | 2 |
Paravalvular Leak(s) | 2 |
Shelf Life Exceeded | 2 |
Crack | 2 |
Biocompatibility | 2 |
Missing Information | 2 |
Heart Valve Leaflet | 2 |
Material Split, Cut Or Torn | 2 |
Occlusion Within Device | 2 |
Unintended System Motion | 1 |
Material Frayed | 1 |
Delivered As Unsterile Product | 1 |
Unraveled Material | 1 |
Heart Valve Sewing Ring | 1 |
Degraded | 1 |
Device Difficult To Setup Or Prepare | 1 |
Use Of Device Problem | 1 |
Activation, Positioning Or Separation Problem | 1 |
Material Integrity Problem | 1 |
Material Disintegration | 1 |
Escape | 1 |
Human-Device Interface Problem | 1 |
Measurement System Incompatibility | 1 |
Migration Or Expulsion Of Device | 1 |
Leaflet Fracture | 1 |
Impedance Problem | 1 |
Positioning Problem | 1 |
Malposition Of Device | 1 |
Entrapment Of Device | 1 |
Valve(s), Sticking | 1 |
Device Expiration Issue | 1 |
Fluid Leak | 1 |
Valve, Flow | 1 |
Difficult To Position | 1 |
Improper Flow Or Infusion | 1 |
Noise, Audible | 1 |
Separation Problem | 1 |
Separation Failure | 1 |
Device Damaged By Another Device | 1 |
Installation-Related Problem | 1 |
Reflux Within Device | 1 |
Material Deformation | 1 |
| Total Device Problems | 1157 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CryoLife, Inc. | II | Mar-28-2019 |
| 2 | CryoLife, Inc. | II | Jul-12-2017 |