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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Stent, Iliac LIGHT-BOOK · MAUDE

#257 of 1000 · 6,991 reports · 1994–2026

  • BOOK 6,991 reports
  • RANK #257 of 1000
  • DEATH 206 death-typed
  • INJ 2,966 injury-typed
  • MALF 3,800 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 650
  • PHOTO Hearing Aid

Nearest event-volume peer: Hearing Aid, Bone Conduction (18 report gap)

Stent, Iliac sits #257 of 1000 among tracked device types with 6,991 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 →

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 2.9% corpus 1.5% · above corpus mean (+1.4 pp)
  • INJ 42.4% corpus 30.4% · above corpus mean (+12.0 pp)
  • MALF 54.4% corpus 64.5% · below corpus mean (-10.2 pp)

Lead product-problem code Device Dislodged or Dislocated is 14% of coded problems · Lead manufacturer AV-TEMECULA-CT accounts for 18% of manufacturer-tagged reports · Top event location is 57% 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 6,991 MAUDE reports, ranked #257 of 1000.

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

Event Types

Malfunction 3,800 (54.4%)
Injury 2,966 (42.4%)
Death 206 (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.

3,682 (48.4%)
Required Intervention 2,361 (31.0%)
R 370 (4.9%)
Hospitalization 345 (4.5%)
Other 275 (3.6%)
Death 199 (2.6%)
Life Threatening 103 (1.4%)
L 88 (1.2%)
H 64 (0.8%)
O 51 (0.7%)
S 49 (0.6%)
Disability 17 (0.2%)
D 2 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Device Dislodged or Dislocated 752
Adverse Event Without Identified Device or Use Problem 639
Difficult to Remove 441
Activation Failure 362
Material Deformation 316
Premature Activation 286
Failure to Advance 282
Improper or Incorrect Procedure or Method 261
Difficult to Advance 248
Off-Label Use 232
Detachment of Device or Device Component 210
Mechanical Jam 195
Positioning Failure 191
Break 188
Difficult or Delayed Positioning 164
Activation, Positioning or Separation Problem 163
Material Separation 118
Fracture 112
Positioning Problem 111
Difficult or Delayed Activation 109

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: 82

Related Entities for Stent, Iliac

Top Manufacturers

AV-TEMECULA-CT 955
ABBOTT VASCULAR 708
BOSTON SCIENTIFIC CORPORATION 568
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG 543
MEDTRONIC IRELAND 541
CORDIS DE MEXICO 535
COOK IRELAND LTD 436
BOSTON SCIENTIFIC - GALWAY 405
ATRIUM MEDICAL CORPORATION 381
BOSTON SCIENTIFIC - MAPLE GROVE 381

Event Locations

3,987 (57.0%)
I 2,455 (35.1%)
HOSPITAL 521 (7.5%)
NO INFORMATION 18 (0.3%)
OTHER 6 (0.1%)
HOME 2 (0.0%)
UNKNOWN 2 (0.0%)

Compare AV-TEMECULA-CT vs ABBOTT VASCULAR →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stent, Iliac, 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 (6,991 here).

Hearing Aid, Bone Conduction 6,973 Warmer, Thermal, Infusion Fluid 6,957 Laryngoscope, Rigid 6,912 Heart-Valve, Mechanical 6,889

Similar death-typed counts

Nearest other device types by death-typed report count (206 here), distinct from the volume row.

Heparin, Vascular Access Flush 206 Controller 204 Compressor, Cardiac, External 201 Catheter 212

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

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.