Definition: To Replace A Patient's Aortic 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 | 1055 |
| Device Name | Aortic 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 3 Medical Device |
| Product Code | NPT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1055 |
| Device | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Product Code | NPT |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4889 |
Valve | 3259 |
Perivalvular Leak | 1726 |
Catheter | 1212 |
Device Dislodged Or Dislocated | 1121 |
Malposition Of Device | 914 |
Balloon | 490 |
Insufficient Information | 380 |
Leak / Splash | 332 |
Burst Container Or Vessel | 307 |
Migration Or Expulsion Of Device | 251 |
Gradient Increase | 247 |
Torn Material | 227 |
Difficult To Remove | 204 |
Fluid Leak | 175 |
Activation Failure Including Expansion Failures | 151 |
Appropriate Term/Code Not Available | 135 |
Incomplete Coaptation | 128 |
Material Separation | 122 |
Calcified | 109 |
Difficult To Advance | 102 |
Difficult To Position | 92 |
Degraded | 86 |
Positioning Problem | 85 |
Inadequacy Of Device Shape And/or Size | 71 |
Unintended Movement | 62 |
Heart Valve Leaflet | 62 |
Difficult Or Delayed Positioning | 53 |
Detachment Of Device Or Device Component | 50 |
Shaft | 47 |
Difficult To Insert | 41 |
Material Rupture | 40 |
Failure To Advance | 39 |
Device Operates Differently Than Expected | 37 |
Positioning Failure | 36 |
Inflation Problem | 35 |
Split | 31 |
Physical Resistance | 30 |
Material Deformation | 26 |
Inaccurate Delivery | 25 |
Leaflet | 23 |
Particulates | 23 |
Tip | 22 |
Detachment Of Device Component | 21 |
Deformation Due To Compressive Stress | 20 |
Kinked | 19 |
Delivery System Failure | 18 |
Material Integrity Problem | 18 |
Fracture | 17 |
Bent | 15 |
Migration | 15 |
Use Of Device Problem | 14 |
Obstruction Of Flow | 13 |
Material Split, Cut Or Torn | 13 |
Entrapment Of Device | 12 |
Delamination | 11 |
Activation, Positioning Or Separation Problem | 11 |
Patient-Device Incompatibility | 11 |
Human-Device Interface Problem | 11 |
Material Fragmentation | 10 |
Hole In Material | 9 |
Folded | 9 |
Device Slipped | 8 |
Occlusion Within Device | 8 |
Hemo Valve | 6 |
Failure To Align | 6 |
Air Leak | 6 |
Device-Device Incompatibility | 6 |
Device Contamination With Chemical Or Other Material | 6 |
Therapy Delivered To Incorrect Body Area | 5 |
Material Protrusion / Extrusion | 5 |
Break | 5 |
Deflation Problem | 5 |
Structural Problem | 4 |
Retraction Problem | 4 |
No Apparent Adverse Event | 4 |
Crack | 4 |
Packaging Problem | 4 |
Material Distortion | 4 |
Device Damaged By Another Device | 4 |
Pilot Balloon Valve | 4 |
Separation Failure | 4 |
Unintended Collision | 3 |
Device Damaged Prior To Use | 3 |
Noise, Audible | 3 |
Shelf Life Exceeded | 3 |
Failure To Unfold Or Unwrap | 3 |
Difficult To Open Or Close | 3 |
Material Twisted / Bent | 3 |
Frame | 3 |
Handpiece | 2 |
Failure To Fire | 2 |
Device Difficult To Setup Or Prepare | 2 |
Material Invagination | 2 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 2 |
Difficult Or Delayed Separation | 2 |
Cannula | 2 |
Material Frayed | 2 |
Cut In Material | 2 |
Device Or Device Fragments Location Unknown | 2 |
| Total Device Problems | 17910 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corporation | I | Jan-13-2015 |
| 2 | CryoLife, Inc. | II | Sep-06-2017 |
| 3 | Edwards Lifesciences, LLC | II | Feb-14-2019 |
| 4 | Edwards Lifesciences, LLC | II | Jul-13-2018 |
| 5 | Edwards Lifesciences, LLC | I | Jan-10-2018 |
| 6 | Edwards Lifesciences, LLC | II | Feb-03-2014 |
| 7 | Medtronic Cardiovascular Surgery-the Heart Valve Division | II | Aug-16-2016 |
| 8 | Medtronic Cardiovascular Surgery-the Heart Valve Division | I | Aug-05-2015 |