Intracranial Coil-assist Stent
Unknown
An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms.
Recent MDR events
806 adverse event reports on file
- NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CEJul 31, 2026MalfunctionStryker Neurovascular Cork3008881809-2026-00481
- NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CEJul 31, 2026MalfunctionStryker Neurovascular Cork3008881809-2026-00484
- NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CEJul 31, 2026MalfunctionStryker Neurovascular Cork3008881809-2026-00485
- LVIS JR.Jul 27, 2026DeathMicrovention, Inc.2032493-2026-08088
- LVIS EVOJul 27, 2026DeathMicrovention, Inc.2032493-2026-08092
- STENTJul 21, 2026InjuryMicrovention, Inc.2032493-2026-08085
- NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CEJul 20, 2026MalfunctionStryker Neurovascular Cork3008881809-2026-00468
- NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CEJul 20, 2026MalfunctionStryker Neurovascular Cork3008881809-2026-00469
- NEUROFORM ATLAS 4.0MM X 21MM NO TIP- PMAJul 16, 2026MalfunctionStryker Neurovascular Cork3008881809-2026-00458
- LVIS EVOJul 16, 2026InjuryMicrovention, Inc.2032493-2026-08074
Event type breakdown
Recalls
2 recall events for this product code
- MICROVENTION INC.Open, ClassifiedMay 14, 2026
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 1
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
Z-2200-2026 · View FDA record ↗ - MICROVENTION INC.Open, ClassifiedFeb 7, 2025
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297.
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Z-1121-2025 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
2 premarket approvals for this product code