Coronary Drug-Eluting Stent
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 Coronary Drug-Eluting Stent HEAVY-BOOK · MAUDE
#33 of 1000 · 128,715 reports · 2003–2026
- BOOK 128,715 reports
- RANK #33 of 1000
- DEATH 11,230 death-typed
- INJ 62,169 injury-typed
- MALF 55,031 malfunction
- SPAN 2003–2026
- PEAK 2012: 8,323
- PHOTO Device
Nearest event-volume peer: Device, Hemostasis, Vascular (4,796 report gap)
Coronary Drug-Eluting Stent sits #33 of 1000 among tracked device types with 128,715 MAUDE reports spanning 2003–2026. 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 →
Malfunction reports sit below the device-type norm
Coronary Drug-Eluting Stent carries 42.8% MALFUNCTION-coded reports, 22.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 8.7% corpus 1.5% · above corpus mean (+7.2 pp)
- INJ 48.3% corpus 30.3% · above corpus mean (+18.0 pp)
- MALF 42.8% corpus 64.8% · below corpus mean (-22.1 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 21% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - GALWAY accounts for 21% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .
Coronary Drug-Eluting Stent in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
138,399 reports
- System
System, Surgical, Computer Controlled Instrument
137,980 reports
- Permanent Def…
Permanent Defibrillator Electrodes
137,720 reports
- Coronary Drug… (this)
Coronary Drug-Eluting Stent
128,715 reports
- Device
Device, Hemostasis, Vascular
123,919 reports
- Electrosurgic…
Electrosurgical, Cutting & Coagulation & Accessories
117,697 reports
What this shows Coronary Drug-Eluting Stent carries 128,715 MAUDE reports, ranked #33 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 (2,500) held close to the prior two-year average of 3,069.
Related Entities for Coronary Drug-Eluting Stent
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Coronary Drug-Eluting 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 (128,715 here).
Similar death-typed counts
Nearest other device types by death-typed report count (11,230 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Coronary Drug-Eluting 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 Coronary Drug-Eluting 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.