Definition: Call For Pmas To Be Filed By 12/9/87 (52 Fr 23137 (6/17/87))
| Device Type ID | 834 |
| Device Name | Replacement Heart-valve |
| Regulation Description | Replacement Heart Valve. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | PMA |
| CFR Regulation Number | 870.3925 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | DYE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 834 |
| Device | Replacement Heart-valve |
| Product Code | DYE |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Replacement Heart Valve. |
| CFR Regulation Number | 870.3925 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 3358 |
Calcified | 1016 |
Degraded | 892 |
Appropriate Term/Code Not Available | 843 |
Incomplete Coaptation | 487 |
Perivalvular Leak | 342 |
Gradient Increase | 237 |
Heart Valve Leaflet | 96 |
Torn Material | 80 |
Restricted Flow Rate | 76 |
Adverse Event Without Identified Device Or Use Problem | 73 |
Inadequacy Of Device Shape And/or Size | 63 |
Leak / Splash | 50 |
Material Deformation | 43 |
Obstruction Of Flow | 17 |
Material Too Rigid Or Stiff | 16 |
Occlusion Within Device | 12 |
Difficult To Open Or Close | 11 |
Malposition Of Device | 11 |
Device Dislodged Or Dislocated | 10 |
Patient-Device Incompatibility | 10 |
No Apparent Adverse Event | 9 |
Hole In Material | 9 |
Device Operates Differently Than Expected | 8 |
Difficult To Fold Or Unfold | 6 |
Material Distortion | 5 |
Material Separation | 4 |
Folded | 4 |
Fracture | 4 |
Device Abrasion From Instrument Or Another Object | 4 |
Retraction Problem | 3 |
Material Split, Cut Or Torn | 3 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 3 |
Activation, Positioning Or Separation Problem | 3 |
Detachment Of Device Component | 3 |
Mechanical Problem | 3 |
Improper Flow Or Infusion | 3 |
Delivery System Failure | 2 |
Material Perforation | 2 |
Biocompatibility | 2 |
Kinked | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Incorrect Device Or Component Shipped | 2 |
Device Damaged By Another Device | 2 |
Patient Device Interaction Problem | 2 |
Structural Problem | 2 |
Particulates | 2 |
Escape | 2 |
Material Discolored | 2 |
Device Appears To Trigger Rejection | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Material Integrity Problem | 1 |
Valve | 1 |
Contamination During Use | 1 |
Bent | 1 |
Migration Or Expulsion Of Device | 1 |
Device Operational Issue | 1 |
Delamination | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Component Missing | 1 |
Activation Failure Including Expansion Failures | 1 |
Connection Problem | 1 |
Coagulation In Device Or Device Ingredient | 1 |
Difficult Or Delayed Positioning | 1 |
Device Packaging Compromised | 1 |
Device Handling Problem | 1 |
Unsealed Device Packaging | 1 |
Loss Of Power | 1 |
Complete Blockage | 1 |
Material Fragmentation | 1 |
Sticking | 1 |
Material Rupture | 1 |
Difficult To Insert | 1 |
Entrapment Of Device | 1 |
Defective Device | 1 |
Difficult To Position | 1 |
Failure To Unfold Or Unwrap | 1 |
Detachment Of Device Or Device Component | 1 |
Break | 1 |
| Total Device Problems | 7871 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Cardiovascular Surgery-the Heart Valve Division | II | Sep-11-2014 |