2026 data FDA MAUDE openFDA

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

#429 of 1000 · 2,583 reports · 2014–2026

  • BOOK 2,583 reports
  • RANK #429 of 1000
  • DEATH 31 death-typed
  • INJ 758 injury-typed
  • MALF 1,794 malfunction
  • SPAN 2014–2026
  • PEAK 2019: 376
  • PHOTO Intraocular Pressure…

Nearest event-volume peer: Intraocular Pressure Lowering Implant (7 report gap)

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment sits #429 of 1000 among tracked device types with 2,583 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 →

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 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 29.3% corpus 30.4% · below corpus mean (-1.1 pp)
  • MALF 69.5% corpus 64.5% · above corpus mean (+4.9 pp)

Lead product-problem code Misfire is 20% of coded problems · Lead manufacturer ANGIOMED GMBH & CO. MEDIZINTECHNIK KG accounts for 56% of manufacturer-tagged reports · Top event location I is 57% 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 2,583 MAUDE reports, ranked #429 of 1000.

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

Event Types

Malfunction 1,794 (69.5%)
Injury 758 (29.3%)
Death 31 (1.2%)

Patient Outcomes

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

1,598 (56.5%)
Required Intervention 463 (16.4%)
Other 303 (10.7%)
Hospitalization 173 (6.1%)
R 154 (5.4%)
O 77 (2.7%)
Death 30 (1.1%)
H 10 (0.4%)
Life Threatening 9 (0.3%)
Disability 5 (0.2%)
S 3 (0.1%)
D 2 (0.1%)

Top Product Problems

Misfire 805
Positioning Failure 799
Fracture 544
Break 354
Adverse Event Without Identified Device or Use Problem 218
Detachment of Device or Device Component 173
Activation Failure 160
Material Deformation 160
Material Perforation 145
Obstruction of Flow 133
Difficult to Remove 82
Malposition of Device 82
Complete Blockage 77
Loss of or Failure to Bond 75
Difficult or Delayed Positioning 71
Retraction Problem 57
Insufficient Information 49
Patient-Device Incompatibility 48
Positioning Problem 46
Difficult to Advance 40

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: 22

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

Event Locations

I 1,481 (57.3%)
1,080 (41.8%)
HOSPITAL 12 (0.5%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for System, 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 (2,583 here).

Similar death-typed counts

Nearest other device types by death-typed report count (31 here), distinct from the volume row.

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.