2026 data FDA MAUDE openFDA FDA Class III

Stent, Iliac

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 LIGHT-BOOK · MAUDE

#261 of 1000 · 7,218 reports · 1994–2026

  • BOOK 7,218 reports
  • RANK #261 of 1000
  • DEATH 211 death-typed
  • INJ 3,052 injury-typed
  • MALF 3,936 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 650
  • PHOTO Nail, Fixation, Bone

Nearest event-volume peer: Nail, Fixation, Bone (12 report gap)

Stent, Iliac sits #261 of 1000 among tracked device types with 7,218 MAUDE reports spanning 1994–2026. 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 carries 42.3% INJURY-coded reports, 12.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.9% corpus 1.5% · above corpus mean (+1.4 pp)
  • INJ 42.3% corpus 30.3% · above corpus mean (+12.0 pp)
  • MALF 54.5% corpus 64.8% · below corpus mean (-10.3 pp)

Lead product-problem code Device Dislodged or Dislocated is 14% of coded problems · Lead manufacturer AV-TEMECULA-CT accounts for 17% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Stent, Iliac in the event-volume neighbourhood

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

reports

What this shows Stent, Iliac carries 7,218 MAUDE reports, ranked #261 of 1000.

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

Event Types

Malfunction 3,936 (54.5%)
Injury 3,052 (42.3%)
Death 211 (2.9%)
12 (0.2%)
Other 7 (0.1%)

Patient Outcomes

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

3,807 (48.5%)
Required Intervention 2,420 (30.8%)
R 381 (4.9%)
Hospitalization 354 (4.5%)
Other 282 (3.6%)
Death 203 (2.6%)
Life Threatening 105 (1.3%)
L 90 (1.1%)
H 72 (0.9%)
O 54 (0.7%)
S 54 (0.7%)
Disability 19 (0.2%)
D 3 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Device Dislodged or Dislocated 1,123
Adverse Event Without Identified Device or Use Problem 903
Difficult to Remove 730
Premature Activation 539
Failure to Advance 420
Material Deformation 419
Activation Failure 413
Improper or Incorrect Procedure or Method 378
Activation, Positioning or Separation Problem 364
Difficult or Delayed Positioning 357
Difficult to Advance 303
Break 261
Detachment of Device or Device Component 253
Positioning Failure 252
Off-Label Use 245
Mechanical Jam 228
Fracture 202
Material Separation 171
Difficult To Position 153
Inaccurate Delivery 141

Yearly Trend

94
1994: 1
02
2002: 4
03
2003: 36
04
2004: 35
05
2005: 49
06
2006: 50
07
2007: 38
08
2008: 68
09
2009: 97
10
2010: 165
11
2011: 256
12
2012: 391
13
2013: 395
14
2014: 436
15
2015: 445
16
2016: 412
17
2017: 462
18
2018: 460
19
2019: 416
20
2020: 409
21
2021: 421
22
2022: 352
23
2023: 351
24
2024: 510
25
2025: 650
26
2026: 309

Reports rose to 650 in 2025, up from an average of 431 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Stent, Iliac

Event Locations

4,201 (58.2%)
I 2,455 (34.0%)
HOSPITAL 534 (7.4%)
NO INFORMATION 18 (0.2%)
OTHER 6 (0.1%)
HOME 2 (0.0%)
UNKNOWN 2 (0.0%)

Compare AV-TEMECULA-CT vs ABBOTT VASCULAR →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stent, Iliac: 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 (7,218 here).

Similar death-typed counts

Nearest other device types by death-typed report count (211 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stent, Iliac 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; 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.