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2026 data FDA MAUDE openFDA

Coronary Covered Stent

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

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FDA MAUDE casebook

openFDA event book Coronary Covered Stent LIGHT-BOOK · MAUDE

#776 of 1000 · 702 reports · 2014–2026

  • BOOK 702 reports
  • RANK #776 of 1000
  • DEATH 97 death-typed
  • INJ 186 injury-typed
  • MALF 419 malfunction
  • SPAN 2014–2026
  • PEAK 2022: 149
  • PHOTO Lectins And Protectins

Nearest event-volume peer: Lectins And Protectins (1 report gap)

Coronary Covered Stent sits #776 of 1000 among tracked device types with 702 MAUDE reports spanning 2014–2026. 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 →

Death-coded reports run above the device-type norm

Coronary Covered Stent carries 13.8% DEATH-coded reports, 12.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 13.8% corpus 1.5% · above corpus mean (+12.3 pp)
  • INJ 26.5% corpus 30.3% · below corpus mean (-3.8 pp)
  • MALF 59.7% corpus 64.8% · below corpus mean (-5.1 pp)

Lead product-problem code Device Dislodged or Dislocated is 42% of coded problems · Lead manufacturer ABBOTT VASCULAR INC. accounts for 97% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .

Coronary Covered Stent in the event-volume neighbourhood

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

reports

What this shows Coronary Covered Stent carries 702 MAUDE reports, ranked #776 of 1000.

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

Event Types

Malfunction 419 (59.7%)
Injury 186 (26.5%)
Death 97 (13.8%)

Patient Outcomes

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

Hospitalization 293 (39.3%)
172 (23.1%)
Death 99 (13.3%)
Other 85 (11.4%)
Required Intervention 50 (6.7%)
H 15 (2.0%)
R 13 (1.7%)
L 11 (1.5%)
D 4 (0.5%)
Life Threatening 2 (0.3%)
O 1 (0.1%)
S 1 (0.1%)

Top Product Problems

Device Dislodged or Dislocated 319
Failure to Advance 163
Lack of Effect 67
Patient Device Interaction Problem 37
Material Deformation 33
Adverse Event Without Identified Device or Use Problem 21
Patient-Device Incompatibility 19
Positioning Problem 17
Material Split, Cut or Torn 14
Use of Device Problem 12
Fracture 10
Improper or Incorrect Procedure or Method 8
Inflation Problem 7
Material Separation 7
Material Rupture 6
Activation Failure 5
Appropriate Device Problem Term/Code Not Available 5
Entrapment of Device 5
Detachment of Device or Device Component 4
Difficult to Remove 4

Yearly Trend

14
2014: 1
15
2015: 1
19
2019: 35
20
2020: 54
21
2021: 78
22
2022: 149
23
2023: 146
24
2024: 57
25
2025: 82
26
2026: 99

Reports in 2025 (82) held close to the prior two-year average of 102.

Related Entities for Coronary Covered Stent

Top Manufacturers

ABBOTT VASCULAR INC. 116
ABBOTT VASCULAR 3
ABBOTT 1

Event Locations

553 (78.8%)
I 140 (19.9%)
HOSPITAL 6 (0.9%)
NO INFORMATION 3 (0.4%)

Compare ABBOTT VASCULAR INC. vs ABBOTT VASCULAR →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Coronary Covered 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 (702 here).

Lectins And Protectins 701 Resin, Root Canal Filling 703 Prosthesis 704 Accessories, Photographic, For Endoscope 698

Similar death-typed counts

Nearest other device types by death-typed report count (97 here), distinct from the volume row.

Shockwave Intravascular Lithotripsy System 98 Cement, Bone, Vertebroplasty 94 Mesh 100 Catheter, Intravascular Occluding, Temporary 101

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

Disclaimer: MAUDE figures for Coronary Covered 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 Covered 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.