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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Intracranial Aneurysm Flow Diverter MID-BOOK · MAUDE

#199 of 1000 · 11,101 reports · 2011–2026

  • BOOK 11,101 reports
  • RANK #199 of 1000
  • DEATH 600 death-typed
  • INJ 3,784 injury-typed
  • MALF 6,715 malfunction
  • SPAN 2011–2026
  • PEAK 2025: 1,643
  • PHOTO Dermal Cooling Pack/V…

Nearest event-volume peer: Dermal Cooling Pack/Vacuum/Massager (10 report gap)

Intracranial Aneurysm Flow Diverter sits #199 of 1000 among tracked device types with 11,101 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 5.4% corpus 1.5% · above corpus mean (+3.9 pp)
  • INJ 34.1% corpus 30.4% · above corpus mean (+3.6 pp)
  • MALF 60.5% corpus 64.5% · below corpus mean (-4.0 pp)

Lead product-problem code Activation Failure is 37% of coded problems · Lead manufacturer MICRO THERAPEUTICS, INC. DBA EV3 accounts for 60% of manufacturer-tagged reports · Top event location is 69% 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 11,101 MAUDE reports, ranked #199 of 1000.

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

Event Types

Malfunction 6,715 (60.5%)
Injury 3,784 (34.1%)
Death 600 (5.4%)
2 (0.0%)

Patient Outcomes

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

6,292 (52.8%)
Required Intervention 1,982 (16.6%)
Other 960 (8.1%)
Death 567 (4.8%)
Disability 562 (4.7%)
R 435 (3.7%)
S 321 (2.7%)
Hospitalization 267 (2.2%)
O 202 (1.7%)
H 116 (1.0%)
Life Threatening 99 (0.8%)
L 64 (0.5%)
D 39 (0.3%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Activation Failure 4,945
Adverse Event Without Identified Device or Use Problem 2,330
Physical Resistance/Sticking 1,457
Material Deformation 1,131
Retraction Problem 460
Activation, Positioning or Separation Problem 442
Unintended Movement 397
Break 389
Migration 253
Positioning Failure 231
Material Frayed 177
Unintended Ejection 174
Material Twisted/Bent 151
Structural Problem 149
Deformation Due to Compressive Stress 139
Premature Activation 117
No Apparent Adverse Event 104
Difficult to Remove 86
Migration or Expulsion of Device 73
Detachment of Device or Device Component 72

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: 271

Related Entities for Intracranial Aneurysm Flow Diverter

Top Manufacturers

MICRO THERAPEUTICS, INC. DBA EV3 6,221
COVIDIEN (IRVINE) 1,305
EV3 NEUROVASCULAR 1,258
STRYKER NEUROVASCULAR CORK 873
MICROVENTION, INC. 478
COVIDIEN 140
COVIDIEN, IRVINE 86

Event Locations

7,659 (69.0%)
I 3,404 (30.7%)
HOSPITAL 27 (0.2%)
NO INFORMATION 11 (0.1%)

Compare MICRO THERAPEUTICS, INC. DBA EV3 vs COVIDIEN (IRVINE) →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Intracranial Aneurysm Flow Diverter, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (11,101 here).

Dermal Cooling Pack/Vacuum/Massager 11,111 Recorder, Event, Implantable Cardiac, 11,120 Catheter, Hemodialysis, Implanted 11,029 Catheter 10,969

Similar death-typed counts

Nearest other device types by death-typed report count (600 here), distinct from the volume row.

Tubes, Gastrointestinal 620 Catheters 578 Monitor, Cardiac 575 Bed, Ac-Powered Adjustable Hospital 638

Read our methodology - how this data is sourced, computed, and verified.

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.