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2026 data FDA MAUDE openFDA

Stent, Coronary

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, Coronary MID-BOOK · MAUDE

#126 of 1000 · 23,266 reports · 1993–2026

  • BOOK 23,266 reports
  • RANK #126 of 1000
  • DEATH 1,758 death-typed
  • INJ 11,927 injury-typed
  • MALF 9,397 malfunction
  • SPAN 1993–2026
  • PEAK 2010: 1,568
  • PHOTO Counter

Nearest event-volume peer: Counter, Differential Cell (144 report gap)

Stent, Coronary sits #126 of 1000 among tracked device types with 23,266 MAUDE reports spanning 1993–2026. 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 7.6% corpus 1.5% · above corpus mean (+6.0 pp)
  • INJ 51.3% corpus 30.4% · above corpus mean (+20.8 pp)
  • MALF 40.4% corpus 64.5% · below corpus mean (-24.1 pp)

Lead product-problem code Failure to Advance is 30% of coded problems · Lead manufacturer AV-TEMECULA-CT accounts for 26% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Stent, Coronary in the event-volume neighbourhood

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

reports

What this shows Stent, Coronary carries 23,266 MAUDE reports, ranked #126 of 1000.

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

Event Types

Injury 11,927 (51.3%)
Malfunction 9,397 (40.4%)
Death 1,758 (7.6%)
Other 131 (0.6%)
53 (0.2%)

Patient Outcomes

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

9,578 (35.8%)
Required Intervention 7,786 (29.1%)
R 2,178 (8.1%)
Hospitalization 1,790 (6.7%)
Death 1,768 (6.6%)
Other 1,768 (6.6%)
S 660 (2.5%)
L 459 (1.7%)
Life Threatening 328 (1.2%)
Disability 255 (1.0%)
H 111 (0.4%)
O 96 (0.4%)
D 5 (0.0%)
Congenital Anomaly 3 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Failure to Advance 1,610
Adverse Event Without Identified Device or Use Problem 631
Improper or Incorrect Procedure or Method 521
Device Dislodged or Dislocated 451
Material Deformation 369
Patient-Device Incompatibility 314
Device Operates Differently Than Expected 247
Difficult to Remove 217
Material Separation 154
Bent 146
Difficult to Advance 129
Off-Label Use 116
Detachment Of Device Component 100
Break 86
Deformation Due to Compressive Stress 74
Difficult To Position 57
Device Expiration Issue 49
Difficult or Delayed Positioning 49
Device Damaged Prior to Use 47
Activation Failure 44

Yearly Trend

93
1993: 3
94
1994: 18
95
1995: 35
96
1996: 275
97
1997: 671
98
1998: 1,070
99
1999: 820
00
2000: 672
01
2001: 698
02
2002: 741
03
2003: 981
04
2004: 844
05
2005: 776
06
2006: 1,141
07
2007: 1,201
08
2008: 1,288
09
2009: 1,370
10
2010: 1,568
11
2011: 1,232
12
2012: 1,053
13
2013: 1,049
14
2014: 876
15
2015: 664
16
2016: 696
17
2017: 695
18
2018: 675
19
2019: 561
20
2020: 430
21
2021: 329
22
2022: 280
23
2023: 207
24
2024: 219
25
2025: 116
26
2026: 12

Related Entities for Stent, Coronary

Top Manufacturers

AV-TEMECULA-CT 4,050
BOSTON SCIENTIFIC 2,159
GUIDANT VASCULAR INTERVENTION 2,158
ABBOTT VASCULAR-CARDIAC THERAPIES 2,029
BOSTON SCIENTIFIC - MAPLE GROVE 1,449
ABBOTT VASCULAR 1,179
MEDTRONIC IRELAND 929
BOSTON SCIENTIFIC - GALWAY 751
BOSTON SCIENTIFIC CORPORATION 664

Event Locations

11,706 (50.3%)
I 3,545 (15.2%)
HOSPITAL 3,195 (13.7%)
UNKNOWN 2,555 (11.0%)
OTHER 2,134 (9.2%)
INVALID DATA 45 (0.2%)
NO INFORMATION 39 (0.2%)
NOT APPLICABLE 26 (0.1%)
HOME 10 (0.0%)
AMBULATORY SURGICAL FACILITY 3 (0.0%)
CATHETERIZATION SUITE 2 (0.0%)
CATHETERIZATION LAB - FREE STANDING 1 (0.0%)
IMAGING CENTER - STATIONARY 1 (0.0%)
NURSING HOME 1 (0.0%)
OPERATING ROOM 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare AV-TEMECULA-CT vs BOSTON SCIENTIFIC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stent, Coronary, 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 (23,266 here).

Counter, Differential Cell 23,410 Mitral Valve Repair Devices 22,972 Fastener 23,725 Programmer, Pacemaker 23,727

Similar death-typed counts

Nearest other device types by death-typed report count (1,758 here), distinct from the volume row.

Stimulator 1,806 Pump, Infusion 1,709 System, Appendage Closure, Left Atrial 1,702 Implantable Pulse Generator, Pacemaker 1,816

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

Disclaimer: MAUDE figures for Stent, Coronary 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, Coronary; 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.