Definition: To Repair The Mitral Valve By Coapting The Valve Leaflets To Prevent Mitral Regurgitation. These Devices Are Different From The Classified Device (annuloplasty Rings) In That A Cardiotomy Is Not Required To Place Them, Some Of Them Are Placed Percuta
| Device Type ID | 1054 |
| Device Name | Mitral Valve Repair Devices |
| 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 | NKM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1054 |
| Device | Mitral Valve Repair Devices |
| Product Code | NKM |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Incomplete Coaptation | 442 |
Adverse Event Without Identified Device Or Use Problem | 353 |
Unintended Movement | 149 |
Difficult To Open Or Close | 143 |
Difficult To Remove | 121 |
Difficult Or Delayed Positioning | 102 |
Improper Or Incorrect Procedure Or Method | 96 |
Off-Label Use | 90 |
Migration | 73 |
Device Damaged By Another Device | 70 |
Break | 68 |
Mechanical Jam | 51 |
Positioning Failure | 50 |
Leak / Splash | 48 |
Failure To Adhere Or Bond | 46 |
Entrapment Of Device | 41 |
Physical Resistance / Sticking | 39 |
Difficult Or Delayed Activation | 38 |
Difficult To Position | 36 |
Expulsion | 34 |
Detachment Of Device Component | 30 |
Material Separation | 27 |
Physical Resistance | 17 |
Bent | 17 |
Deformation Due To Compressive Stress | 17 |
Material Deformation | 15 |
Mechanical Problem | 14 |
Unstable | 12 |
Retraction Problem | 11 |
Device Operates Differently Than Expected | 10 |
Premature Activation | 10 |
Material Protrusion / Extrusion | 9 |
Material Split, Cut Or Torn | 9 |
Product Quality Problem | 8 |
Difficult To Insert | 8 |
Difficult To Flush | 6 |
Physical Property Issue | 5 |
Crack | 5 |
Insufficient Information | 4 |
Difficult To Advance | 4 |
Knotted | 4 |
Loose Or Intermittent Connection | 3 |
Noise, Audible | 3 |
Torn Material | 2 |
Stretched | 2 |
Kinked | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Failure To Advance | 1 |
No Apparent Adverse Event | 1 |
Loss Of Or Failure To Bond | 1 |
Activation, Positioning Or Separation Problem | 1 |
Material Frayed | 1 |
Activation Failure Including Expansion Failures | 1 |
Separation Failure | 1 |
Defective Device | 1 |
| Total Device Problems | 2356 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Vascular | I | Mar-07-2016 |