2026 data FDA MAUDE openFDA

Stent, Superficial Femoral Artery, Drug-Eluting

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 LIGHT-BOOK · MAUDE

#416 of 1000 · 2,790 reports · 2004–2026

  • BOOK 2,790 reports
  • RANK #416 of 1000
  • DEATH 15 death-typed
  • INJ 1,958 injury-typed
  • MALF 817 malfunction
  • SPAN 2004–2026
  • PEAK 2020: 319
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Electrical, Evoked Response (5 report gap)

Stent, Superficial Femoral Artery, Drug-Eluting sits #416 of 1000 among tracked device types with 2,790 MAUDE reports spanning 2004–2026. 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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 70.2% corpus 30.4% · above corpus mean (+39.7 pp)
  • MALF 29.3% corpus 64.5% · below corpus mean (-35.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 33% of coded problems · Lead manufacturer COOK IRELAND LTD accounts for 50% of manufacturer-tagged reports · Top event location HOSPITAL is 50% of location-tagged rows .

Stent in the event-volume neighbourhood

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

reports

What this shows Stent, Superficial Femoral Artery, Drug-Eluting carries 2,790 MAUDE reports, ranked #416 of 1000.

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

Event Types

Injury 1,958 (70.2%)
Malfunction 817 (29.3%)
Death 15 (0.5%)

Patient Outcomes

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

Required Intervention 1,477 (48.3%)
933 (30.5%)
R 175 (5.7%)
Hospitalization 170 (5.6%)
Other 142 (4.6%)
H 64 (2.1%)
O 29 (0.9%)
S 24 (0.8%)
Disability 15 (0.5%)
Life Threatening 15 (0.5%)
Death 14 (0.5%)
L 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 982
Activation, Positioning or Separation Problem 448
Occlusion Within Device 281
Fracture 263
Material Deformation 237
Entrapment of Device 98
Activation Failure 79
Improper or Incorrect Procedure or Method 69
Difficult to Remove 68
Premature Activation 68
Off-Label Use 54
Obstruction of Flow 50
Stretched 42
Difficult or Delayed Positioning 35
Break 34
Deformation Due to Compressive Stress 33
Positioning Problem 31
Delivery System Failure 30
Failure to Advance 30
Appropriate Term/Code Not Available 29

Yearly Trend

04
2004: 1
06
2006: 1
13
2013: 20
14
2014: 169
15
2015: 168
16
2016: 232
17
2017: 279
18
2018: 194
19
2019: 295
20
2020: 319
21
2021: 225
22
2022: 254
23
2023: 248
24
2024: 175
25
2025: 183
26
2026: 27

Related Entities for Stent, Superficial Femoral Artery, Drug-Eluting

Event Locations

HOSPITAL 1,400 (50.2%)
694 (24.9%)
I 685 (24.6%)
HOME 6 (0.2%)
NO INFORMATION 3 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
NURSING HOME 1 (0.0%)

Compare COOK IRELAND LTD vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stent, 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 (2,790 here).

Similar death-typed counts

Nearest other device types by death-typed report count (15 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stent 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; 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.