2026 data FDA MAUDE openFDA FDA Class III

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

#234 of 1000 · 8,649 reports · 2002–2026

  • BOOK 8,649 reports
  • RANK #234 of 1000
  • DEATH 695 death-typed
  • INJ 5,625 injury-typed
  • MALF 2,287 malfunction
  • SPAN 2002–2026
  • PEAK 2010: 1,039
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Thrombus Retriever (32 report gap)

Stent, Carotid sits #234 of 1000 among tracked device types with 8,649 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 →

Malfunction reports sit below the device-type norm

Stent, Carotid carries 26.4% MALFUNCTION-coded reports, 38.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 8.0% corpus 1.5% · above corpus mean (+6.5 pp)
  • INJ 65.0% corpus 30.3% · above corpus mean (+34.7 pp)
  • MALF 26.4% corpus 64.8% · below corpus mean (-38.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 31% of coded problems · Lead manufacturer CORDIS DE MEXICO accounts for 36% of manufacturer-tagged reports · Top event location is 67% 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 8,649 MAUDE reports, ranked #234 of 1000.

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

Event Types

Injury 5,625 (65.0%)
Malfunction 2,287 (26.4%)
Death 695 (8.0%)
Other 31 (0.4%)
11 (0.1%)

Patient Outcomes

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

2,378 (19.0%)
Hospitalization 2,350 (18.8%)
R 1,780 (14.2%)
Required Intervention 1,683 (13.5%)
S 1,184 (9.5%)
Death 746 (6.0%)
Other 739 (5.9%)
L 627 (5.0%)
Disability 443 (3.5%)
Life Threatening 285 (2.3%)
H 165 (1.3%)
O 106 (0.8%)
D 7 (0.1%)
C 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,737
Unknown (for use when the device problem is not known) 1,466
Device remains implanted 688
Other (for use when an appropriate device code cannot be identified) 392
Difficult to Remove 364
Difficult or Delayed Positioning 331
Activation, Positioning or Separation Problem 328
Occlusion Within Device 297
Break 279
Inaccurate Delivery 256
Premature Activation 255
Positioning Failure 200
Activation Failure 193
Insufficient Device Problem Information 174
Material Deformation 167
Entrapment of Device 137
Detachment Of Device Component 130
Migration or Expulsion of Device 118
Failure to Advance 110
Difficult to Advance 108

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: 1,039
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: 379

Reports rose to 593 in 2025, up from an average of 219 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Stent, Carotid

Event Locations

5,813 (67.2%)
OTHER 1,082 (12.5%)
I 953 (11.0%)
UNKNOWN 637 (7.4%)
HOSPITAL 141 (1.6%)
NOT APPLICABLE 11 (0.1%)
NO INFORMATION 9 (0.1%)
HOME 2 (0.0%)
NURSING HOME 1 (0.0%)

Compare CORDIS DE MEXICO vs AV-TEMECULA-CT →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stent, Carotid: 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 (8,649 here).

Similar death-typed counts

Nearest other device types by death-typed report count (695 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.