2026 data FDA MAUDE openFDA FDA Class III

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

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 System LIGHT-BOOK · MAUDE

#430 of 1000 · 2,731 reports · 2014–2026

  • BOOK 2,731 reports
  • RANK #430 of 1000
  • DEATH 31 death-typed
  • INJ 824 injury-typed
  • MALF 1,876 malfunction
  • SPAN 2014–2026
  • PEAK 2019: 376
  • PHOTO Drills

Nearest event-volume peer: Drills, Burrs, Trephines & Accessories (Compound, Powered) (5 report gap)

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment sits #430 of 1000 among tracked device types with 2,731 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 →

Malfunction reports run above the device-type norm

System carries 68.7% MALFUNCTION-coded reports, 3.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 30.2% corpus 30.3% · near corpus mean (-0.1 pp)
  • MALF 68.7% corpus 64.8% · above corpus mean (+3.9 pp)

Lead product-problem code Positioning Failure is 20% of coded problems · Lead manufacturer ANGIOMED GMBH & CO. MEDIZINTECHNIK KG accounts for 55% of manufacturer-tagged reports · Top event location I is 54% of location-tagged rows .

System in the event-volume neighbourhood

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

reports

What this shows System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment carries 2,731 MAUDE reports, ranked #430 of 1000.

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

Event Types

Malfunction 1,876 (68.7%)
Injury 824 (30.2%)
Death 31 (1.1%)

Patient Outcomes

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

1,673 (56.1%)
Required Intervention 504 (16.9%)
Other 305 (10.2%)
Hospitalization 185 (6.2%)
R 167 (5.6%)
O 78 (2.6%)
Death 31 (1.0%)
Life Threatening 13 (0.4%)
H 12 (0.4%)
Disability 5 (0.2%)
S 3 (0.1%)
D 2 (0.1%)
L 2 (0.1%)

Top Product Problems

Positioning Failure 866
Misfire 833
Fracture 573
Break 371
Adverse Event Without Identified Device or Use Problem 267
Detachment of Device or Device Component 184
Material Deformation 176
Activation Failure 169
Material Perforation 154
Obstruction of Flow 134
Malposition of Device 89
Difficult to Remove 85
Complete Blockage 77
Difficult or Delayed Positioning 76
Loss of or Failure to Bond 76
Retraction Problem 59
Insufficient Device Problem Information 49
Patient-Device Incompatibility 48
Positioning Problem 46
Difficult to Advance 45

Yearly Trend

14
2014: 1
15
2015: 54
16
2016: 82
17
2017: 195
18
2018: 343
19
2019: 376
20
2020: 337
21
2021: 281
22
2022: 261
23
2023: 229
24
2024: 209
25
2025: 193
26
2026: 170

Reports in 2025 (193) held close to the prior two-year average of 219.

Related Entities for System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

Event Locations

I 1,481 (54.2%)
1,228 (45.0%)
HOSPITAL 12 (0.4%)
OUTPATIENT TREATMENT FACILITY 5 (0.2%)
NO INFORMATION 3 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
DIALYSIS CENTER 1 (0.0%)

Compare ANGIOMED GMBH & CO. MEDIZINTECHNIK KG vs BARD PERIPHERAL VASCULAR, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Disclaimer: MAUDE figures for System 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 System; 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.