2026 data FDA MAUDE openFDA

Intracranial Neurovascular 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 Neurovascular Stent LIGHT-BOOK · MAUDE

#248 of 1000 · 7,840 reports · 2003–2026

  • BOOK 7,840 reports
  • RANK #248 of 1000
  • DEATH 537 death-typed
  • INJ 2,904 injury-typed
  • MALF 4,380 malfunction
  • SPAN 2003–2026
  • PEAK 2025: 826
  • PHOTO Defibrillator

Nearest event-volume peer: Defibrillator, Implantable, Dual-Chamber (4 report gap)

Intracranial Neurovascular Stent sits #248 of 1000 among tracked device types with 7,840 MAUDE reports spanning 2003–2026. 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 sit below the device-type norm

Intracranial Neurovascular Stent carries 55.9% MALFUNCTION-coded reports, 9.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 6.8% corpus 1.5% · above corpus mean (+5.3 pp)
  • INJ 37.0% corpus 30.3% · above corpus mean (+6.7 pp)
  • MALF 55.9% corpus 64.8% · below corpus mean (-9.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 26% of coded problems · Lead manufacturer MEDOS INTERNATIONAL SARL accounts for 65% of manufacturer-tagged reports · Top event location is 76% of location-tagged rows .

Intracranial Neurovascular Stent in the event-volume neighbourhood

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

reports

What this shows Intracranial Neurovascular Stent carries 7,840 MAUDE reports, ranked #248 of 1000.

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

Event Types

Malfunction 4,380 (55.9%)
Injury 2,904 (37.0%)
Death 537 (6.8%)
16 (0.2%)
Other 3 (0.0%)

Patient Outcomes

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

4,502 (50.7%)
Required Intervention 1,026 (11.6%)
Other 804 (9.1%)
R 647 (7.3%)
Life Threatening 550 (6.2%)
Death 527 (5.9%)
Hospitalization 296 (3.3%)
L 173 (1.9%)
O 153 (1.7%)
S 111 (1.3%)
H 38 (0.4%)
Disability 32 (0.4%)
D 14 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,195
Premature Activation 1,754
Failure to Advance 1,701
Activation Failure 489
Other (for use when an appropriate device code cannot be identified) 337
Fracture 272
Break 214
Activation, Positioning or Separation Problem 181
Migration or Expulsion of Device 172
Occlusion Within Device 131
Physical Resistance 126
Delivery System Failure 121
Material Separation 99
Material Twisted/Bent 93
Difficult to Remove 92
Difficult or Delayed Activation 90
Difficult to Advance 90
Device remains implanted 88
Premature Separation 83
Retraction Problem 83

Yearly Trend

03
2003: 25
04
2004: 35
05
2005: 49
06
2006: 115
07
2007: 148
08
2008: 270
09
2009: 331
10
2010: 306
11
2011: 355
12
2012: 265
13
2013: 331
14
2014: 282
15
2015: 329
16
2016: 310
17
2017: 285
18
2018: 422
19
2019: 272
20
2020: 193
21
2021: 382
22
2022: 395
23
2023: 579
24
2024: 727
25
2025: 826
26
2026: 608

Reports in 2025 (826) held close to the prior two-year average of 653.

Related Entities for Intracranial Neurovascular Stent

Event Locations

5,966 (76.1%)
I 1,822 (23.2%)
HOSPITAL 33 (0.4%)
NO INFORMATION 16 (0.2%)
HOME 2 (0.0%)
OTHER 1 (0.0%)

Compare MEDOS INTERNATIONAL SARL vs STRYKER NEUROVASCULAR CORK →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Intracranial Neurovascular 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 (7,840 here).

Similar death-typed counts

Nearest other device types by death-typed report count (537 here), distinct from the volume row.

Disclaimer: MAUDE figures for Intracranial Neurovascular 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 Neurovascular 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.