| Device Type ID | 1014 |
| Device Name | Heart-valve, Non-allograft Tissue |
| 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 | LWR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1014 |
| Device | Heart-valve, Non-allograft Tissue |
| Product Code | LWR |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Insufficient Information | 1518 |
Adverse Event Without Identified Device Or Use Problem | 457 |
Gradient Increase | 398 |
Perivalvular Leak | 272 |
Incomplete Coaptation | 146 |
Calcified | 145 |
Torn Material | 144 |
Obstruction Of Flow | 124 |
Inadequacy Of Device Shape And/or Size | 123 |
Leak / Splash | 114 |
Material Deformation | 106 |
Appropriate Term/Code Not Available | 82 |
Material Split, Cut Or Torn | 82 |
Material Too Rigid Or Stiff | 66 |
Device Operates Differently Than Expected | 58 |
Occlusion Within Device | 51 |
Patient-Device Incompatibility | 43 |
Microbial Contamination Of Device | 36 |
Structural Problem | 29 |
Malposition Of Device | 28 |
Material Rupture | 28 |
Material Distortion | 28 |
Device Dislodged Or Dislocated | 27 |
No Apparent Adverse Event | 23 |
Material Perforation | 18 |
Difficult To Fold Or Unfold | 16 |
Biocompatibility | 15 |
Degraded | 15 |
Missing Information | 14 |
Material Separation | 13 |
Hole In Material | 13 |
Folded | 12 |
Kinked | 11 |
Cusp | 8 |
Off-Label Use | 7 |
Fluid Leak | 7 |
Valve | 7 |
Material Integrity Problem | 6 |
Activation Failure Including Expansion Failures | 6 |
Material Puncture / Hole | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
Patient Device Interaction Problem | 5 |
Detachment Of Device Or Device Component | 4 |
Migration | 4 |
Migration Or Expulsion Of Device | 4 |
Use Of Device Problem | 4 |
Material Invagination | 4 |
Naturally Worn | 3 |
Cut In Material | 3 |
Break | 3 |
Collapse | 3 |
Positioning Problem | 3 |
Device Handling Problem | 3 |
Partial Blockage | 3 |
Detachment Of Device Component | 2 |
Restricted Flow Rate | 2 |
Mechanical Problem | 2 |
Delivery System Failure | 2 |
Device Abrasion From Instrument Or Another Object | 2 |
Therapeutic Or Diagnostic Output Failure | 2 |
Activation, Positioning Or Separation Problem | 2 |
Difficult To Open Or Close | 2 |
Fracture | 2 |
Bent | 2 |
Material Twisted / Bent | 2 |
Material Discolored | 2 |
Product Quality Problem | 1 |
Device Appears To Trigger Rejection | 1 |
Device Inoperable | 1 |
Defective Component | 1 |
Failure To Adhere Or Bond | 1 |
Leaflet | 1 |
Device Operational Issue | 1 |
Escape | 1 |
Wrinkled | 1 |
Deformation Due To Compressive Stress | 1 |
Capturing Problem | 1 |
Device Difficult To Setup Or Prepare | 1 |
Explanted | 1 |
Stent | 1 |
Invalid Sensing | 1 |
Valve(s), Defective | 1 |
Cuff | 1 |
Difficult Or Delayed Positioning | 1 |
Material Frayed | 1 |
Improper Flow Or Infusion | 1 |
Shelf Life Exceeded | 1 |
Device Slipped | 1 |
Stretched | 1 |
Split | 1 |
Device Damaged Prior To Use | 1 |
Fungus In Device Environment | 1 |
Loose Or Intermittent Connection | 1 |
Post | 1 |
Entrapment Of Device | 1 |
Material Erosion | 1 |
Device Markings / Labelling Problem | 1 |
Free Or Unrestricted Flow | 1 |
Fuse | 1 |
Valve(s), Failure Of | 1 |
| Total Device Problems | 4410 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Cardiovascular Surgery-the Heart Valve Division | II | Feb-03-2014 |
| 2 | Sorin Group USA, Inc. | II | Dec-07-2016 |