2026 data FDA MAUDE openFDA FDA Class III

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

#211 of 1000 · 10,573 reports · 2003–2026

  • BOOK 10,573 reports
  • RANK #211 of 1000
  • DEATH 185 death-typed
  • INJ 4,954 injury-typed
  • MALF 5,420 malfunction
  • SPAN 2003–2026
  • PEAK 2024: 1,013
  • PHOTO Appliance

Nearest event-volume peer: Appliance, Fixation, Spinal Intervertebral Body (19 report gap)

Stent, Superficial Femoral Artery sits #211 of 1000 among tracked device types with 10,573 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 →

Injury-coded reports run above the device-type norm

Stent, Superficial Femoral Artery carries 46.9% INJURY-coded reports, 16.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 46.9% corpus 30.3% · above corpus mean (+16.6 pp)
  • MALF 51.3% corpus 64.8% · below corpus mean (-13.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 14% of coded problems · Lead manufacturer ANGIOMED GMBH & CO. MEDIZINTECHNIK KG accounts for 24% of manufacturer-tagged reports · Top event location is 55% 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 10,573 MAUDE reports, ranked #211 of 1000.

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

Event Types

Malfunction 5,420 (51.3%)
Injury 4,954 (46.9%)
Death 185 (1.7%)
7 (0.1%)
Other 7 (0.1%)

Patient Outcomes

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

5,103 (43.2%)
Required Intervention 3,429 (29.0%)
Hospitalization 942 (8.0%)
R 842 (7.1%)
Other 809 (6.8%)
Death 176 (1.5%)
S 153 (1.3%)
H 147 (1.2%)
O 100 (0.8%)
Disability 60 (0.5%)
L 19 (0.2%)
Life Threatening 16 (0.1%)
D 14 (0.1%)
C 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,790
Activation Failure 1,276
Fracture 1,007
Break 919
Material Deformation 845
Difficult to Remove 828
Activation, Positioning or Separation Problem 815
Positioning Failure 737
Material Separation 667
Premature Activation 533
Detachment of Device or Device Component 434
Stretched 421
Improper or Incorrect Procedure or Method 414
Detachment Of Device Component 409
Difficult or Delayed Positioning 379
Occlusion Within Device 371
Failure to Advance 310
Difficult or Delayed Activation 308
Difficult to Advance 264
Material Twisted/Bent 235

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: 416

Reports in 2025 (851) held close to the prior two-year average of 944.

Related Entities for Stent, Superficial Femoral Artery

Event Locations

5,831 (55.1%)
I 4,490 (42.5%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stent, Superficial Femoral Artery: 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 (10,573 here).

Similar death-typed counts

Nearest other device types by death-typed report count (185 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.