Definition: Approved PMA: P000039
| Device Type ID | 1031 |
| Device Name | Transcatheter Septal Occluder |
| 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 | MLV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1031 |
| Device | Transcatheter Septal Occluder |
| Product Code | MLV |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Material Deformation | 133 |
Unintended Movement | 68 |
Adverse Event Without Identified Device Or Use Problem | 53 |
Migration Or Expulsion Of Device | 29 |
Insufficient Information | 26 |
Leak / Splash | 9 |
Device Operates Differently Than Expected | 9 |
Positioning Problem | 7 |
Patient Device Interaction Problem | 6 |
Material Erosion | 5 |
Retraction Problem | 5 |
Device Dislodged Or Dislocated | 5 |
Difficult To Remove | 4 |
Migration | 4 |
Detachment Of Device Component | 4 |
Inadequacy Of Device Shape And/or Size | 3 |
Entrapment Of Device | 3 |
Break | 3 |
Difficult Or Delayed Positioning | 3 |
Extrusion | 2 |
Cord | 2 |
Obstruction Of Flow | 2 |
Patient-Device Incompatibility | 2 |
Fracture | 2 |
Biocompatibility | 2 |
Positioning Failure | 2 |
Off-Label Use | 2 |
Sticking | 1 |
Difficult To Insert | 1 |
Failure To Disconnect | 1 |
Malposition Of Device | 1 |
Difficult To Position | 1 |
Premature Activation | 1 |
Shunt | 1 |
Frame | 1 |
Failure To Advance | 1 |
Activation, Positioning Or Separation Problem | 1 |
Use Of Device Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Difficult Or Delayed Separation | 1 |
Perivalvular Leak | 1 |
| Total Device Problems | 409 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |