What are FDA adverse event reports for Coronary Covered Stent?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Coronary Covered Stent, there are 632 total reports including 92 death reports and 133 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Coronary Covered Stent?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Coronary Covered Stent

Name: Coronary Covered Stent - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

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

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Coronary Covered Stent LIGHT-BOOK · MAUDE

#791 of 1000 · 632 reports · 2014–2026

BOOK 632 reports
RANK #791 of 1000
DEATH 92 death-typed
INJ 133 injury-typed
MALF 407 malfunction
SPAN 2014–2026
PEAK 2022: 149
PHOTO Elevator

Nearest event-volume peer: Elevator, Surgical, Dental (2 report gap)

Coronary Covered Stent sits #791 of 1000 among tracked device types with 632 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 →

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 14.6% corpus 1.5% · above corpus mean (+13.0 pp)
INJ 21.0% corpus 30.4% · below corpus mean (-9.4 pp)
MALF 64.4% corpus 64.5% · near corpus mean (-0.1 pp)

Lead product-problem code Device Dislodged or Dislocated is 45% of coded problems · Lead manufacturer BIOTRONIK AG, BUELACH, SWITZERLAND accounts for 90% of manufacturer-tagged reports · Top event location is 76% of location-tagged rows .

Elevator

634
Coronary Cove… (this)

632
Hearing Aid

629
Regulator

629
Full Field Di…

627
Aberrometer

626

What this shows Coronary Covered Stent carries 632 MAUDE reports, ranked #791 of 1000.

Event Types

Malfunction 407 (64.4%)

Injury 133 (21.0%)

Death 92 (14.6%)

Patient Outcomes

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

Hospitalization 290 (43.3%)

160 (23.9%)

Death 94 (14.1%)

Other 42 (6.3%)

Required Intervention 41 (6.1%)

H 14 (2.1%)

L 11 (1.6%)

R 10 (1.5%)

D 4 (0.6%)

Life Threatening 2 (0.3%)

O 1 (0.1%)

Yearly Trend

2014: 1

2015: 1

2019: 35

2020: 54

2021: 78

2022: 149

2023: 146

2024: 57

2025: 82

2026: 29

Top Manufacturers

BIOTRONIK AG, BUELACH, SWITZERLAND 524

ABBOTT VASCULAR INC. 59

ABBOTT 1

ABBOTT VASCULAR 1

Event Locations

483 (76.4%)

I 140 (22.2%)

HOSPITAL 6 (0.9%)

NO INFORMATION 3 (0.5%)

Compare BIOTRONIK AG, BUELACH, SWITZERLAND vs ABBOTT VASCULAR INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Coronary Covered 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 (632 here).

Elevator, Surgical, Dental 634 Hearing Aid 629 Regulator, Pressure, Gas Cylinder 629 Full Field Digital 627

Similar death-typed counts

Nearest other device types by death-typed report count (92 here), distinct from the volume row.

Agent, Absorbable Hemostatic, Collagen Based 92 Shockwave Intravascular Lithotripsy System 91 System, Dialysate Delivery, Single Patient 93 Cement, Bone, Vertebroplasty 94

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.

Coronary Covered Stent

Event-type mix vs corpus