Definition: An Intracranial Neurovascular Stent Is A Tubular Device Placed In The Blood Vessel Of The Intracranial Cavity To Treat A Vascular Abnormality. It Differs From Other Stents In That It Is Intended For Intracranial Use.
| Device Type ID | 3851 |
| Device Name | Intracranial Neurovascular Stent |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | NJE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3851 |
| Device | Intracranial Neurovascular Stent |
| Product Code | NJE |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 640 |
Stent | 210 |
Premature Activation | 93 |
Activation, Positioning Or Separation Problem | 58 |
Break | 55 |
Premature Separation | 47 |
Activation Failure Including Expansion Failures | 45 |
Physical Resistance | 41 |
Migration Or Expulsion Of Device | 38 |
Difficult Or Delayed Positioning | 28 |
Failure To Advance | 23 |
Difficult To Remove | 20 |
Retraction Problem | 15 |
Physical Resistance / Sticking | 13 |
Occlusion Within Device | 12 |
Device Operates Differently Than Expected | 12 |
No Apparent Adverse Event | 11 |
Peeled / Delaminated | 8 |
Coil | 7 |
Difficult To Advance | 7 |
Malposition Of Device | 7 |
Device Markings / Labelling Problem | 6 |
Detachment Of Device Component | 6 |
Difficult Or Delayed Activation | 5 |
Device Dislodged Or Dislocated | 5 |
Bent | 4 |
Positioning Failure | 4 |
Device Issue | 4 |
Material Separation | 3 |
Partial Blockage | 3 |
Device-Device Incompatibility | 3 |
Kinked | 3 |
Positioning Problem | 3 |
Radiation Underexposure | 3 |
Detachment Of Device Or Device Component | 3 |
Missing Value Reason | 3 |
Material Twisted / Bent | 3 |
Migration | 3 |
Failure To Capture | 2 |
Failure To Deliver | 2 |
Activation Problem | 2 |
Insufficient Information | 2 |
Flushing Problem | 2 |
Stretched | 2 |
Entrapment Of Device | 2 |
Difficult To Fold Or Unfold | 2 |
Unintended Movement | 2 |
Off-Label Use | 2 |
Air Leak | 1 |
Separation Failure | 1 |
Material Protrusion / Extrusion | 1 |
Mechanical Jam | 1 |
Leak / Splash | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Material Deformation | 1 |
Difficult To Insert | 1 |
Device Damaged Prior To Use | 1 |
Biocompatibility | 1 |
Aborted Charge | 1 |
Inaccurate Delivery | 1 |
Delivery System Failure | 1 |
Difficult To Position | 1 |
Device Expiration Issue | 1 |
Material Too Soft / Flexible | 1 |
Catheter | 1 |
Appropriate Term/Code Not Available | 1 |
Shipping Damage Or Problem | 1 |
Device Difficult To Setup Or Prepare | 1 |
Wire | 1 |
Material Discolored | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 1497 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Neurovascular | II | Sep-07-2018 |
| 2 | Stryker Neurovascular | II | Dec-16-2014 |