2026 data FDA MAUDE openFDA FDA Class III

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

#445 of 1000 · 2,591 reports · 2017–2026

  • BOOK 2,591 reports
  • RANK #445 of 1000
  • DEATH 73 death-typed
  • INJ 1,018 injury-typed
  • MALF 1,500 malfunction
  • SPAN 2017–2026
  • PEAK 2025: 477
  • PHOTO Integrated Continuous…

Nearest event-volume peer: Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter (9 report gap)

Iliac Covered Stent, Arterial sits #445 of 1000 among tracked device types with 2,591 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 →

Injury-coded reports run above the device-type norm

Iliac Covered Stent, Arterial carries 39.3% INJURY-coded reports, 9.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.8% corpus 1.5% · above corpus mean (+1.3 pp)
  • INJ 39.3% corpus 30.3% · above corpus mean (+9.0 pp)
  • MALF 57.9% corpus 64.8% · below corpus mean (-6.9 pp)

Lead product-problem code Device Dislodged or Dislocated is 39% of coded problems · Lead manufacturer W. L. GORE & ASSOCIATES, INC. accounts for 91% of manufacturer-tagged reports · Top event location is 78% 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 2,591 MAUDE reports, ranked #445 of 1000.

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

Event Types

Malfunction 1,500 (57.9%)
Injury 1,018 (39.3%)
Death 73 (2.8%)

Patient Outcomes

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

1,423 (48.7%)
Required Intervention 536 (18.3%)
Other 340 (11.6%)
Hospitalization 199 (6.8%)
R 133 (4.6%)
O 93 (3.2%)
H 92 (3.1%)
Death 54 (1.8%)
L 14 (0.5%)
S 14 (0.5%)
Disability 14 (0.5%)
D 9 (0.3%)
Life Threatening 1 (0.0%)

Top Product Problems

Device Dislodged or Dislocated 1,104
Adverse Event Without Identified Device or Use Problem 206
Device-Device Incompatibility 191
Material Deformation 158
Complete Blockage 154
Detachment of Device or Device Component 112
Obstruction of Flow 102
Failure to Advance 86
Patient-Device Incompatibility 86
Device Endoleak 76
Device Stenosis 73
Premature Separation 70
Migration 58
Collapse 56
Retraction Problem 54
Insufficient Device Problem Information 48
Partial Blockage 45
Difficult to Advance 42
Activation, Positioning or Separation Problem 40
Break 38

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: 365

Reports in 2025 (477) held close to the prior two-year average of 376.

Related Entities for Iliac Covered Stent, Arterial

Event Locations

2,011 (77.6%)
I 463 (17.9%)
HOSPITAL 103 (4.0%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Iliac Covered Stent, Arterial: 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 (2,591 here).

Similar death-typed counts

Nearest other device types by death-typed report count (73 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.