2026 data FDA MAUDE openFDA

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

#32 of 1000 · 127,490 reports · 2003–2026

  • BOOK 127,490 reports
  • RANK #32 of 1000
  • DEATH 11,160 death-typed
  • INJ 61,719 injury-typed
  • MALF 54,326 malfunction
  • SPAN 2003–2026
  • PEAK 2012: 8,323
  • PHOTO Permanent Defibrillat…

Nearest event-volume peer: Permanent Defibrillator Electrodes (5,309 report gap)

Coronary Drug-Eluting Stent sits #32 of 1000 among tracked device types with 127,490 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 →

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 8.8% corpus 1.5% · above corpus mean (+7.2 pp)
  • INJ 48.4% corpus 30.4% · above corpus mean (+18.0 pp)
  • MALF 42.6% corpus 64.5% · below corpus mean (-21.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 26% 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

reports

What this shows Coronary Drug-Eluting Stent carries 127,490 MAUDE reports, ranked #32 of 1000.

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

Event Types

Injury 61,719 (48.4%)
Malfunction 54,326 (42.6%)
Death 11,160 (8.8%)
184 (0.1%)
Other 101 (0.1%)

Patient Outcomes

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

55,064 (35.2%)
Required Intervention 31,766 (20.3%)
Hospitalization 20,031 (12.8%)
R 18,869 (12.0%)
Death 11,224 (7.2%)
Other 6,296 (4.0%)
L 5,015 (3.2%)
Life Threatening 2,585 (1.7%)
S 2,212 (1.4%)
H 1,577 (1.0%)
O 1,350 (0.9%)
Disability 471 (0.3%)
D 113 (0.1%)
Congenital Anomaly 19 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 16,585
Material Deformation 10,942
Failure to Advance 8,726
Device Dislodged or Dislocated 6,969
Bent 3,554
Difficult to Remove 3,156
Break 2,793
Difficult to Advance 1,428
Occlusion Within Device 1,170
Improper or Incorrect Procedure or Method 925
Device Damaged by Another Device 904
Device Damaged Prior to Use 896
Material Rupture 751
Fracture 744
Inflation Problem 725
Activation, Positioning or Separation Problem 621
Positioning Problem 573
Material Separation 560
Activation Failure 518
Detachment of Device or Device Component 511

Yearly Trend

03
2003: 1,552
04
2004: 4,386
05
2005: 4,093
06
2006: 5,930
07
2007: 4,851
08
2008: 5,096
09
2009: 7,107
10
2010: 5,839
11
2011: 7,101
12
2012: 8,323
13
2013: 7,563
14
2014: 6,666
15
2015: 6,142
16
2016: 7,233
17
2017: 6,786
18
2018: 6,817
19
2019: 7,254
20
2020: 6,362
21
2021: 5,268
22
2022: 4,068
23
2023: 3,097
24
2024: 3,041
25
2025: 2,500
26
2026: 415

Related Entities for Coronary Drug-Eluting Stent

Event Locations

77,578 (60.9%)
I 41,318 (32.4%)
HOSPITAL 4,291 (3.4%)
OTHER 3,381 (2.7%)
UNKNOWN 331 (0.3%)
HOME 306 (0.2%)
NO INFORMATION 247 (0.2%)
INVALID DATA 16 (0.0%)
AMBULATORY SURGICAL FACILITY 13 (0.0%)
OUTPATIENT TREATMENT FACILITY 5 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
NURSING HOME 1 (0.0%)
PUBLIC VENUE 1 (0.0%)

Compare BOSTON SCIENTIFIC - GALWAY vs MEDTRONIC IRELAND →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Coronary Drug-Eluting 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 (127,490 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11,160 here), distinct from the volume row.

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.