2026 data FDA MAUDE openFDA

Stent, Superficial Femoral Artery

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, Superficial Femoral Artery MID-BOOK · MAUDE

#209 of 1000 · 10,266 reports · 2003–2026

  • BOOK 10,266 reports
  • RANK #209 of 1000
  • DEATH 181 death-typed
  • INJ 4,848 injury-typed
  • MALF 5,223 malfunction
  • SPAN 2003–2026
  • PEAK 2024: 1,013
  • PHOTO Ligator, Esophageal

Nearest event-volume peer: Ligator, Esophageal (80 report gap)

Stent, Superficial Femoral Artery sits #209 of 1000 among tracked device types with 10,266 MAUDE reports spanning 2003–2026. 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 1.8% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 47.2% corpus 30.4% · above corpus mean (+16.8 pp)
  • MALF 50.9% corpus 64.5% · below corpus mean (-13.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 15% of coded problems · Lead manufacturer ANGIOMED GMBH & CO. MEDIZINTECHNIK KG accounts for 23% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Stent, Superficial Femoral Artery in the event-volume neighbourhood

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

reports

What this shows Stent, Superficial Femoral Artery carries 10,266 MAUDE reports, ranked #209 of 1000.

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

Event Types

Malfunction 5,223 (50.9%)
Injury 4,848 (47.2%)
Death 181 (1.8%)
7 (0.1%)
Other 7 (0.1%)

Patient Outcomes

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

4,920 (42.8%)
Required Intervention 3,362 (29.2%)
Hospitalization 938 (8.2%)
R 834 (7.2%)
Other 787 (6.8%)
Death 174 (1.5%)
S 151 (1.3%)
H 138 (1.2%)
O 96 (0.8%)
Disability 58 (0.5%)
L 19 (0.2%)
Life Threatening 16 (0.1%)
D 12 (0.1%)
C 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,550
Activation Failure 1,170
Material Deformation 740
Break 717
Fracture 713
Activation, Positioning or Separation Problem 680
Difficult to Remove 620
Material Separation 605
Positioning Failure 440
Premature Activation 435
Stretched 372
Detachment of Device or Device Component 363
Improper or Incorrect Procedure or Method 349
Difficult or Delayed Activation 302
Failure to Advance 249
Difficult or Delayed Positioning 240
Difficult to Advance 227
Mechanical Jam 220
Detachment Of Device Component 216
Entrapment of Device 187

Yearly Trend

03
2003: 13
04
2004: 30
05
2005: 19
06
2006: 15
07
2007: 32
08
2008: 87
09
2009: 152
10
2010: 119
11
2011: 119
12
2012: 211
13
2013: 250
14
2014: 403
15
2015: 600
16
2016: 846
17
2017: 789
18
2018: 546
19
2019: 717
20
2020: 802
21
2021: 837
22
2022: 831
23
2023: 875
24
2024: 1,013
25
2025: 851
26
2026: 109

Related Entities for Stent, Superficial Femoral Artery

Event Locations

5,520 (53.8%)
I 4,494 (43.8%)
HOSPITAL 165 (1.6%)
NO INFORMATION 49 (0.5%)
NOT APPLICABLE 16 (0.2%)
OTHER 8 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 6 (0.1%)
OUTPATIENT TREATMENT FACILITY 6 (0.1%)
HOME 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare ANGIOMED GMBH & CO. MEDIZINTECHNIK KG vs ABBOTT VASCULAR →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stent, Superficial Femoral Artery, 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 (10,266 here).

Similar death-typed counts

Nearest other device types by death-typed report count (181 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stent, Superficial Femoral Artery 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, Superficial Femoral Artery; 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.