2026 data FDA MAUDE openFDA FDA Class III

Stent, Iliac Vein

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 Stent, Iliac Vein LIGHT-BOOK · MAUDE

#606 of 1000 · 1,289 reports · 2019–2026

  • BOOK 1,289 reports
  • RANK #606 of 1000
  • DEATH 7 death-typed
  • INJ 537 injury-typed
  • MALF 745 malfunction
  • SPAN 2019–2026
  • PEAK 2021: 425
  • PHOTO Solid State X-Ray Ima…

Nearest event-volume peer: Solid State X-Ray Imager (Flat Panel/Digital Imager) (12 report gap)

Stent, Iliac Vein sits #606 of 1000 among tracked device types with 1,289 MAUDE reports spanning 2019–2026. 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

Stent, Iliac Vein carries 41.7% INJURY-coded reports, 11.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 41.7% corpus 30.3% · above corpus mean (+11.4 pp)
  • MALF 57.8% corpus 64.8% · below corpus mean (-7.0 pp)

Lead product-problem code Activation Failure is 27% of coded problems · Lead manufacturer ANGIOMED GMBH & CO. MEDIZINTECHNIK KG accounts for 50% of manufacturer-tagged reports · Top event location is 46% of location-tagged rows .

Stent, Iliac Vein in the event-volume neighbourhood

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

reports

What this shows Stent, Iliac Vein carries 1,289 MAUDE reports, ranked #606 of 1000.

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

Event Types

Malfunction 745 (57.8%)
Injury 537 (41.7%)
Death 7 (0.5%)

Patient Outcomes

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

458 (33.7%)
Required Intervention 380 (28.0%)
Other 357 (26.3%)
R 50 (3.7%)
Hospitalization 39 (2.9%)
Life Threatening 26 (1.9%)
O 15 (1.1%)
L 14 (1.0%)
H 7 (0.5%)
Death 7 (0.5%)
S 3 (0.2%)
Disability 3 (0.2%)

Top Product Problems

Activation Failure 423
Adverse Event Without Identified Device or Use Problem 237
Material Deformation 127
Migration 100
Activation, Positioning or Separation Problem 86
Fracture 86
Improper or Incorrect Procedure or Method 53
Migration or Expulsion of Device 48
Positioning Failure 44
Obstruction of Flow 42
Off-Label Use 41
Malposition of Device 37
Misfire 34
Detachment of Device or Device Component 32
Difficult to Remove 32
Entrapment of Device 30
Break 29
Use of Device Problem 29
Deformation Due to Compressive Stress 21
Difficult or Delayed Positioning 21

Yearly Trend

19
2019: 24
20
2020: 117
21
2021: 425
22
2022: 115
23
2023: 208
24
2024: 128
25
2025: 177
26
2026: 95

Reports in 2025 (177) held close to the prior two-year average of 168.

Related Entities for Stent, Iliac Vein

Event Locations

593 (46.0%)
I 440 (34.1%)
HOSPITAL 245 (19.0%)
NO INFORMATION 11 (0.9%)

Compare ANGIOMED GMBH & CO. MEDIZINTECHNIK KG vs COVIDIEN →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stent, Iliac Vein: 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 (1,289 here).

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stent, Iliac Vein 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 Stent, Iliac Vein; 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.