2026 data FDA MAUDE openFDA FDA Class III

Intracranial Aneurysm Flow Diverter

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 Aneurysm Flow Diverter MID-BOOK · MAUDE

#194 of 1000 · 11,926 reports · 2011–2026

  • BOOK 11,926 reports
  • RANK #194 of 1000
  • DEATH 616 death-typed
  • INJ 3,934 injury-typed
  • MALF 7,374 malfunction
  • SPAN 2011–2026
  • PEAK 2025: 1,643
  • PHOTO Tampon

Nearest event-volume peer: Tampon, Menstrual, Unscented (61 report gap)

Intracranial Aneurysm Flow Diverter sits #194 of 1000 among tracked device types with 11,926 MAUDE reports spanning 2011–2026. 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 →

Death-coded reports run above the device-type norm

Intracranial Aneurysm Flow Diverter carries 5.2% DEATH-coded reports, 3.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 5.2% corpus 1.5% · above corpus mean (+3.7 pp)
  • INJ 33.0% corpus 30.3% · above corpus mean (+2.7 pp)
  • MALF 61.8% corpus 64.8% · below corpus mean (-3.0 pp)

Lead product-problem code Activation Failure is 35% of coded problems · Lead manufacturer MICRO THERAPEUTICS, INC. DBA EV3 accounts for 71% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Intracranial Aneurysm Flow Diverter in the event-volume neighbourhood

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

reports

What this shows Intracranial Aneurysm Flow Diverter carries 11,926 MAUDE reports, ranked #194 of 1000.

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

Event Types

Malfunction 7,374 (61.8%)
Injury 3,934 (33.0%)
Death 616 (5.2%)
2 (0.0%)

Patient Outcomes

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

6,943 (54.3%)
Required Intervention 2,071 (16.2%)
Other 1,016 (7.9%)
Death 578 (4.5%)
Disability 570 (4.5%)
R 451 (3.5%)
S 326 (2.5%)
Hospitalization 274 (2.1%)
O 219 (1.7%)
H 128 (1.0%)
Life Threatening 104 (0.8%)
L 73 (0.6%)
D 41 (0.3%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Activation Failure 5,703
Adverse Event Without Identified Device or Use Problem 2,727
Physical Resistance/Sticking 1,693
Material Deformation 1,336
Retraction Problem 624
Activation, Positioning or Separation Problem 584
Break 498
Unintended Movement 464
Positioning Failure 399
Difficult to Open or Close 281
Migration 273
Material Twisted/Bent 233
Unintended Ejection 232
Device Operates Differently Than Expected 224
Material Frayed 217
Insufficient Device Problem Information 212
Structural Problem 187
Difficult to Remove 157
Premature Activation 152
Migration or Expulsion of Device 148

Yearly Trend

11
2011: 4
12
2012: 335
13
2013: 618
14
2014: 438
15
2015: 562
16
2016: 540
17
2017: 448
18
2018: 425
19
2019: 528
20
2020: 809
21
2021: 850
22
2022: 1,118
23
2023: 1,186
24
2024: 1,326
25
2025: 1,643
26
2026: 1,096

Reports in 2025 (1,643) held close to the prior two-year average of 1,256.

Related Entities for Intracranial Aneurysm Flow Diverter

Event Locations

8,485 (71.1%)
I 3,403 (28.5%)
HOSPITAL 27 (0.2%)
NO INFORMATION 11 (0.1%)

Compare MICRO THERAPEUTICS, INC. DBA EV3 vs EV3 NEUROVASCULAR →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Intracranial Aneurysm Flow Diverter: 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 (11,926 here).

Similar death-typed counts

Nearest other device types by death-typed report count (616 here), distinct from the volume row.

Disclaimer: MAUDE figures for Intracranial Aneurysm Flow Diverter 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 Aneurysm Flow Diverter; 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.