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2026 data FDA MAUDE openFDA FDA Class III

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

#130 of 1000 · 23,279 reports · 1993–2026

  • BOOK 23,279 reports
  • RANK #130 of 1000
  • DEATH 1,758 death-typed
  • INJ 11,933 injury-typed
  • MALF 9,403 malfunction
  • SPAN 1993–2026
  • PEAK 2010: 1,568
  • PHOTO Screwdriver

Nearest event-volume peer: Screwdriver (23 report gap)

Stent, Coronary sits #130 of 1000 among tracked device types with 23,279 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 →

Malfunction reports sit below the device-type norm

Stent, Coronary carries 40.4% MALFUNCTION-coded reports, 24.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 7.6% corpus 1.5% · above corpus mean (+6.0 pp)
  • INJ 51.3% corpus 30.3% · above corpus mean (+21.0 pp)
  • MALF 40.4% corpus 64.8% · below corpus mean (-24.4 pp)

Lead product-problem code Failure to Advance is 16% 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 23,279 MAUDE reports, ranked #130 of 1000.

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

Event Types

Injury 11,933 (51.3%)
Malfunction 9,403 (40.4%)
Death 1,758 (7.6%)
Other 132 (0.6%)
53 (0.2%)

Patient Outcomes

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

9,584 (35.8%)
Required Intervention 7,788 (29.1%)
R 2,180 (8.1%)
Hospitalization 1,795 (6.7%)
Death 1,768 (6.6%)
Other 1,768 (6.6%)
S 661 (2.5%)
L 459 (1.7%)
Life Threatening 328 (1.2%)
Disability 254 (0.9%)
H 112 (0.4%)
O 97 (0.4%)
D 5 (0.0%)
Congenital Anomaly 3 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Failure to Advance 4,856
Dislodged 3,701
Difficult to Remove 2,373
Replace 1,756
Device Dislodged or Dislocated 1,627
Difficult to Insert 1,573
Adverse Event Without Identified Device or Use Problem 1,537
Device remains implanted 1,475
Improper or Incorrect Procedure or Method 1,257
Occlusion Within Device 1,097
Use of Device Problem 1,088
Unknown (for use when the device problem is not known) 1,016
Balloon rupture 1,012
Device Damaged Prior to Use 892
Other (for use when an appropriate device code cannot be identified) 870
Bent 842
Material Separation 816
Device, or device fragments remain in patient 783
Detachment Of Device Component 770
Difficult or Delayed Positioning 705

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: 1,233
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: 24

Reports fell to 116 in 2025, down from an average of 213 in the two years before.

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 1,182
MEDTRONIC IRELAND 932
BOSTON SCIENTIFIC - GALWAY 751
BOSTON SCIENTIFIC CORPORATION 669

Event Locations

11,719 (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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stent, Coronary: 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 (23,279 here).

Screwdriver 23,256 Prosthesis 23,248 Counter, Differential Cell 23,439 Instrument, Biopsy 23,840

Similar death-typed counts

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

Pump, Infusion 1,751 Mitral Valve Repair Devices 1,771 System, Appendage Closure, Left Atrial 1,816 Implantable Pulse Generator, Pacemaker 1,854

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.