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
#423 of 1000 · 2,846 reports · 2004–2026
- BOOK 2,846 reports
- RANK #423 of 1000
- DEATH 16 death-typed
- INJ 1,993 injury-typed
- MALF 837 malfunction
- SPAN 2004–2026
- PEAK 2020: 319
- PHOTO Nebulizer
Nearest event-volume peer: Nebulizer (Direct Patient Interface) (1 report gap)
Stent, Superficial Femoral Artery, Drug-Eluting sits #423 of 1000 among tracked device types with 2,846 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 →
Injury-coded reports run above the device-type norm
Stent carries 70.0% INJURY-coded reports, 39.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
- INJ 70.0% corpus 30.3% · above corpus mean (+39.7 pp)
- MALF 29.4% corpus 64.8% · below corpus mean (-35.4 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 31% 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
- Lithotriptor
Lithotriptor, Biliary Mechanical
2,875 reports
- Pin
Pin, Fixation, Smooth
2,868 reports
- Instrument
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
2,859 reports
- Nebulizer
Nebulizer (Direct Patient Interface)
2,847 reports
- Stent (this)
Stent, Superficial Femoral Artery, Drug-Eluting
2,846 reports
- Prosthesis
Prosthesis, Penis, Inflatable
2,835 reports
What this shows Stent, Superficial Femoral Artery, Drug-Eluting carries 2,846 MAUDE reports, ranked #423 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (183) held close to the prior two-year average of 212.
Related Entities for Stent, Superficial Femoral Artery, Drug-Eluting
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Stent: 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 (2,846 here).
Similar death-typed counts
Nearest other device types by death-typed report count (16 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.