2026 data FDA MAUDE openFDA FDA Class III

Agent, Occluding, Vascular, Permanent

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 Agent, Occluding, Vascular, Permanent LIGHT-BOOK · MAUDE

#597 of 1000 · 1,325 reports · 2015–2026

  • BOOK 1,325 reports
  • RANK #597 of 1000
  • DEATH 18 death-typed
  • INJ 1,228 injury-typed
  • MALF 78 malfunction
  • SPAN 2015–2026
  • PEAK 2022: 180
  • PHOTO Intrauterine Tamponad…

Nearest event-volume peer: Intrauterine Tamponade Balloon (3 report gap)

Agent, Occluding, Vascular, Permanent sits #597 of 1000 among tracked device types with 1,325 MAUDE reports spanning 2015–2026. 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

Agent, Occluding, Vascular, Permanent carries 92.7% INJURY-coded reports, 62.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 92.7% corpus 30.3% · above corpus mean (+62.4 pp)
  • MALF 5.9% corpus 64.8% · below corpus mean (-58.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 47% of coded problems · Lead manufacturer MEDTRONIC IRELAND accounts for 93% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Agent, Occluding, Vascular, Permanent in the event-volume neighbourhood

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

reports

What this shows Agent, Occluding, Vascular, Permanent carries 1,325 MAUDE reports, ranked #597 of 1000.

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

Event Types

Injury 1,228 (92.7%)
Malfunction 78 (5.9%)
Death 18 (1.4%)
Other 1 (0.1%)

Patient Outcomes

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

Required Intervention 937 (62.6%)
Hospitalization 129 (8.6%)
120 (8.0%)
Other 112 (7.5%)
R 109 (7.3%)
O 36 (2.4%)
H 20 (1.3%)
Death 17 (1.1%)
S 7 (0.5%)
L 6 (0.4%)
Life Threatening 2 (0.1%)
D 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 655
Biocompatibility 520
Patient-Device Incompatibility 74
Detachment of Device or Device Component 26
Migration or Expulsion of Device 18
Activation, Positioning or Separation Problem 12
Difficult to Remove 12
Defective Device 11
Obstruction of Flow 10
Material Deformation 9
Use of Device Problem 8
Delivered as Unsterile Product 7
Compatibility Problem 5
Device Difficult to Setup or Prepare 4
Difficult to Advance 4
Deformation Due to Compressive Stress 3
Device Contamination with Chemical or Other Material 3
Improper or Incorrect Procedure or Method 3
Migration 3
Nonstandard Device 3

Yearly Trend

15
2015: 6
16
2016: 41
17
2017: 69
18
2018: 110
19
2019: 162
20
2020: 152
21
2021: 161
22
2022: 180
23
2023: 154
24
2024: 112
25
2025: 101
26
2026: 77

Reports in 2025 (101) held close to the prior two-year average of 133.

Related Entities for Agent, Occluding, Vascular, Permanent

Event Locations

692 (52.2%)
I 622 (46.9%)
NO INFORMATION 11 (0.8%)

Compare MEDTRONIC IRELAND vs COVIDIEN →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Agent, Occluding, Vascular, Permanent: 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 (1,325 here).

Similar death-typed counts

Nearest other device types by death-typed report count (18 here), distinct from the volume row.

Disclaimer: MAUDE figures for Agent, Occluding, Vascular, Permanent 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 Agent, Occluding, Vascular, Permanent; 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.