2026 data FDA MAUDE openFDA

Iliac Covered Stent, Arterial

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 Iliac Covered Stent, Arterial LIGHT-BOOK · MAUDE

#449 of 1000 · 2,308 reports · 2017–2026

  • BOOK 2,308 reports
  • RANK #449 of 1000
  • DEATH 70 death-typed
  • INJ 885 injury-typed
  • MALF 1,353 malfunction
  • SPAN 2017–2026
  • PEAK 2025: 477
  • PHOTO Intervertebral Fusion…

Nearest event-volume peer: Intervertebral Fusion Device With Integrated Fixation, Cervical (6 report gap)

Iliac Covered Stent, Arterial sits #449 of 1000 among tracked device types with 2,308 MAUDE reports spanning 2017–2026. 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 3.0% corpus 1.5% · above corpus mean (+1.5 pp)
  • INJ 38.3% corpus 30.4% · above corpus mean (+7.9 pp)
  • MALF 58.6% corpus 64.5% · below corpus mean (-5.9 pp)

Lead product-problem code Device Dislodged or Dislocated is 40% of coded problems · Lead manufacturer W. L. GORE & ASSOCIATES, INC. accounts for 92% of manufacturer-tagged reports · Top event location is 75% of location-tagged rows .

Iliac Covered Stent, Arterial in the event-volume neighbourhood

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

reports

What this shows Iliac Covered Stent, Arterial carries 2,308 MAUDE reports, ranked #449 of 1000.

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

Event Types

Malfunction 1,353 (58.6%)
Injury 885 (38.3%)
Death 70 (3.0%)

Patient Outcomes

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

1,234 (48.3%)
Required Intervention 460 (18.0%)
Other 293 (11.5%)
Hospitalization 193 (7.6%)
R 116 (4.5%)
O 80 (3.1%)
H 78 (3.1%)
Death 52 (2.0%)
S 14 (0.5%)
Disability 13 (0.5%)
L 12 (0.5%)
D 9 (0.4%)
Life Threatening 1 (0.0%)

Top Product Problems

Device Dislodged or Dislocated 990
Adverse Event Without Identified Device or Use Problem 185
Device-Device Incompatibility 184
Material Deformation 138
Complete Blockage 122
Detachment of Device or Device Component 103
Obstruction of Flow 96
Failure to Advance 79
Patient-Device Incompatibility 74
Device Stenosis 62
Premature Separation 59
Endoleaks 56
Migration 54
Retraction Problem 54
Collapse 53
Insufficient Information 45
Activation, Positioning or Separation Problem 39
Partial Blockage 37
Difficult to Advance 36
Break 35

Yearly Trend

17
2017: 91
18
2018: 102
19
2019: 99
20
2020: 184
21
2021: 235
22
2022: 287
23
2023: 303
24
2024: 448
25
2025: 477
26
2026: 82

Related Entities for Iliac Covered Stent, Arterial

Event Locations

1,729 (74.9%)
I 463 (20.1%)
HOSPITAL 102 (4.4%)
NO INFORMATION 10 (0.4%)
OTHER 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
CLINIC - WALK IN, OTHER 1 (0.0%)

Compare W. L. GORE & ASSOCIATES, INC. vs ATRIUM MEDICAL CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Iliac Covered Stent, Arterial, 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 (2,308 here).

Similar death-typed counts

Nearest other device types by death-typed report count (70 here), distinct from the volume row.

Disclaimer: MAUDE figures for Iliac Covered Stent, Arterial 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 Iliac Covered Stent, Arterial; 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.