2026 data FDA MAUDE openFDA FDA Class III

Percutaneously Delivered Prostheses And Tricuspid Valves

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 Percutaneously Delivered Prostheses And Tri… LIGHT-BOOK · MAUDE

#677 of 1000 · 965 reports · 2024–2026

  • BOOK 965 reports
  • RANK #677 of 1000
  • DEATH 80 death-typed
  • INJ 862 injury-typed
  • MALF 23 malfunction
  • SPAN 2024–2026
  • PEAK 2026: 499
  • PHOTO Alarm

Nearest event-volume peer: Alarm, Conditioned Response Enuresis (0 report gap)

Percutaneously Delivered Prostheses And Tricuspid Valves sits #677 of 1000 among tracked device types with 965 MAUDE reports spanning 2024–2026. 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 sit below the device-type norm

Percutaneously Delivered Prostheses And Tri… carries 2.4% MALFUNCTION-coded reports, 62.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 8.3% corpus 1.5% · above corpus mean (+6.8 pp)
  • INJ 89.3% corpus 30.3% · above corpus mean (+59.0 pp)
  • MALF 2.4% corpus 64.8% · below corpus mean (-62.4 pp)

Lead product-problem code Patient Device Interaction Problem is 42% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 96% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .

Percutaneously Delivered Prostheses And Tri… in the event-volume neighbourhood

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

reports

What this shows Percutaneously Delivered Prostheses And Tricuspid Valves carries 965 MAUDE reports, ranked #677 of 1000.

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

Event Types

Injury 862 (89.3%)
Death 80 (8.3%)
Malfunction 23 (2.4%)

Patient Outcomes

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

Required Intervention 630 (63.1%)
Other 176 (17.6%)
Death 70 (7.0%)
R 33 (3.3%)
Hospitalization 33 (3.3%)
23 (2.3%)
H 21 (2.1%)
D 10 (1.0%)
O 2 (0.2%)

Top Product Problems

Patient Device Interaction Problem 437
Insufficient Device Problem Information 223
Malposition of Device 109
Migration 91
Difficult to Insert 36
Intravalvular regurgitation 28
Perivalvular Leak 26
Device-Device Incompatibility 22
Adverse Event Without Identified Device or Use Problem 13
Difficult or Delayed Activation 13
Difficult to Remove 5
Gradient Increase 5
Activation, Positioning or Separation Problem 4
Device Stenosis 4
Detachment of Device or Device Component 3
Material Integrity Problem 3
Migration or Expulsion of Device 3
Particulates 3
Unspecified Valve Regurgitation 3
Defective Component 2

Yearly Trend

24
2024: 133
25
2025: 333
26
2026: 499

Related Entities for Percutaneously Delivered Prostheses And Tricuspid Valves

Event Locations

964 (99.9%)
HOSPITAL 1 (0.1%)

Compare EDWARDS LIFESCIENCES vs Edwards Lifesciences →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Percutaneously Delivered Prostheses And Tri…: 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 (965 here).

Similar death-typed counts

Nearest other device types by death-typed report count (80 here), distinct from the volume row.

Disclaimer: MAUDE figures for Percutaneously Delivered Prostheses And Tri… 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 Percutaneously Delivered Prostheses And Tri…; 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.