2026 data FDA MAUDE openFDA

Stent, Carotid

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 Stent, Carotid LIGHT-BOOK · MAUDE

#235 of 1000 · 8,339 reports · 2002–2026

  • BOOK 8,339 reports
  • RANK #235 of 1000
  • DEATH 681 death-typed
  • INJ 5,533 injury-typed
  • MALF 2,083 malfunction
  • SPAN 2002–2026
  • PEAK 2010: 1,038
  • PHOTO Acid

Nearest event-volume peer: Acid, Hyaluronic, Intraarticular (17 report gap)

Stent, Carotid sits #235 of 1000 among tracked device types with 8,339 MAUDE reports spanning 2002–2026. 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 8.2% corpus 1.5% · above corpus mean (+6.6 pp)
  • INJ 66.4% corpus 30.4% · above corpus mean (+35.9 pp)
  • MALF 25.0% corpus 64.5% · below corpus mean (-39.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 26% of coded problems · Lead manufacturer CORDIS DE MEXICO accounts for 37% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .

Stent, Carotid in the event-volume neighbourhood

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

reports

What this shows Stent, Carotid carries 8,339 MAUDE reports, ranked #235 of 1000.

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

Event Types

Injury 5,533 (66.4%)
Malfunction 2,083 (25.0%)
Death 681 (8.2%)
Other 31 (0.4%)
11 (0.1%)

Patient Outcomes

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

Hospitalization 2,334 (19.2%)
2,194 (18.0%)
R 1,770 (14.5%)
Required Intervention 1,630 (13.4%)
S 1,181 (9.7%)
Death 735 (6.0%)
Other 723 (5.9%)
L 626 (5.1%)
Disability 438 (3.6%)
Life Threatening 284 (2.3%)
H 151 (1.2%)
O 98 (0.8%)
D 6 (0.0%)
C 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 616
Activation, Positioning or Separation Problem 230
Difficult to Remove 210
Difficult or Delayed Positioning 192
Material Deformation 153
Activation Failure 127
Entrapment of Device 120
Break 99
Difficult to Advance 92
Premature Activation 92
Positioning Failure 70
Material Separation 64
Detachment of Device or Device Component 61
Insufficient Information 46
Mechanical Problem 43
Fracture 42
Positioning Problem 42
Failure to Advance 40
Detachment Of Device Component 32
Defective Device 30

Yearly Trend

02
2002: 1
03
2003: 1
04
2004: 34
05
2005: 304
06
2006: 464
07
2007: 493
08
2008: 790
09
2009: 961
10
2010: 1,038
11
2011: 720
12
2012: 560
13
2013: 469
14
2014: 201
15
2015: 127
16
2016: 121
17
2017: 133
18
2018: 103
19
2019: 181
20
2020: 164
21
2021: 202
22
2022: 172
23
2023: 172
24
2024: 265
25
2025: 593
26
2026: 70

Related Entities for Stent, Carotid

Event Locations

5,543 (66.5%)
OTHER 1,082 (13.0%)
I 953 (11.4%)
UNKNOWN 637 (7.6%)
HOSPITAL 102 (1.2%)
NOT APPLICABLE 11 (0.1%)
NO INFORMATION 9 (0.1%)
HOME 1 (0.0%)
NURSING HOME 1 (0.0%)

Compare CORDIS DE MEXICO vs AV-TEMECULA-CT →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stent, Carotid, 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 (8,339 here).

Similar death-typed counts

Nearest other device types by death-typed report count (681 here), distinct from the volume row.

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