2026 data FDA MAUDE openFDA FDA Class III

Intracranial Coil-Assist Stent

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Intracranial Coil-Assist Stent LIGHT-BOOK · MAUDE

#729 of 1000 · 806 reports · 2019–2026

  • BOOK 806 reports
  • RANK #729 of 1000
  • DEATH 10 death-typed
  • INJ 256 injury-typed
  • MALF 540 malfunction
  • SPAN 2019–2026
  • PEAK 2025: 323
  • PHOTO Cannula, Ophthalmic

Nearest event-volume peer: Cannula, Ophthalmic (1 report gap)

Intracranial Coil-Assist Stent sits #729 of 1000 among tracked device types with 806 MAUDE reports spanning 2019–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Intracranial Coil-Assist Stent carries 67.0% MALFUNCTION-coded reports, 2.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 31.8% corpus 30.3% · above corpus mean (+1.5 pp)
  • MALF 67.0% corpus 64.8% · above corpus mean (+2.2 pp)

Lead product-problem code Premature Activation is 37% of coded problems · Lead manufacturer STRYKER NEUROVASCULAR CORK accounts for 58% of manufacturer-tagged reports · Top event location is 95% of location-tagged rows .

Intracranial Coil-Assist Stent in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Intracranial Coil-Assist Stent carries 806 MAUDE reports, ranked #729 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 540 (67.0%)
Injury 256 (31.8%)
Death 10 (1.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

518 (63.2%)
Required Intervention 155 (18.9%)
Other 64 (7.8%)
R 31 (3.8%)
O 13 (1.6%)
Hospitalization 11 (1.3%)
Death 10 (1.2%)
H 7 (0.9%)
S 4 (0.5%)
Disability 4 (0.5%)
L 2 (0.2%)

Top Product Problems

Premature Activation 315
Adverse Event Without Identified Device or Use Problem 170
Fracture 76
Retraction Problem 60
Activation Failure 52
Difficult or Delayed Activation 50
Activation Problem 24
Migration 19
Break 15
Detachment of Device or Device Component 9
Difficult to Fold, Unfold or Collapse 8
Difficult to Open or Close 7
Entrapment of Device 7
Component Missing 6
Device Stenosis 6
Material Separation 6
Structural Problem 6
Device Dislodged or Dislocated 5
Difficult to Insert 5
Difficult to Remove 5

Yearly Trend

19
2019: 9
20
2020: 16
21
2021: 14
22
2022: 23
23
2023: 58
24
2024: 153
25
2025: 323
26
2026: 210

Reports rose to 323 in 2025, up from an average of 106 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Intracranial Coil-Assist Stent

Event Locations

765 (94.9%)
I 37 (4.6%)
HOSPITAL 3 (0.4%)
NO INFORMATION 1 (0.1%)

Compare STRYKER NEUROVASCULAR CORK vs MICROVENTION, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Intracranial Coil-Assist Stent: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (806 here).

Similar death-typed counts

Nearest other device types by death-typed report count (10 here), distinct from the volume row.

Disclaimer: MAUDE figures for Intracranial Coil-Assist Stent are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Intracranial Coil-Assist Stent; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.