2026 data FDA MAUDE openFDA

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

#857 of 1000 · 519 reports · 2024–2026

  • BOOK 519 reports
  • RANK #857 of 1000
  • DEATH 33 death-typed
  • INJ 478 injury-typed
  • MALF 8 malfunction
  • SPAN 2024–2026
  • PEAK 2025: 333
  • PHOTO System

Nearest event-volume peer: System, Test, Rheumatoid Factor (2 report gap)

Percutaneously Delivered Prostheses And Tricuspid Valves sits #857 of 1000 among tracked device types with 519 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 →

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 6.4% corpus 1.5% · above corpus mean (+4.8 pp)
  • INJ 92.1% corpus 30.4% · above corpus mean (+61.7 pp)
  • MALF 1.5% corpus 64.5% · below corpus mean (-63.0 pp)

Lead product-problem code Patient Device Interaction Problem is 54% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 99% 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 519 MAUDE reports, ranked #857 of 1000.

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

Event Types

Injury 478 (92.1%)
Death 33 (6.4%)
Malfunction 8 (1.5%)

Patient Outcomes

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

Required Intervention 433 (77.9%)
Death 29 (5.2%)
R 23 (4.1%)
Hospitalization 22 (4.0%)
Other 22 (4.0%)
9 (1.6%)
H 9 (1.6%)
D 8 (1.4%)
O 1 (0.2%)

Top Product Problems

Patient Device Interaction Problem 308
Malposition of Device 82
Migration 64
Difficult to Insert 31
Intravalvular regurgitation 26
Perivalvular Leak 16
Device-Device Incompatibility 14
Gradient Increase 5
Activation, Positioning or Separation Problem 4
Difficult to Remove 4
Detachment of Device or Device Component 3
Device Stenosis 3
Material Integrity Problem 3
Particulates 3
Defective Component 2
Insufficient Information 2
Adverse Event Without Identified Device or Use Problem 1
Degraded 1
Mechanical Problem 1
Migration or Expulsion of Device 1

Yearly Trend

24
2024: 133
25
2025: 333
26
2026: 53

Related Entities for Percutaneously Delivered Prostheses And Tricuspid Valves

Event Locations

518 (99.8%)
HOSPITAL 1 (0.2%)

Compare EDWARDS LIFESCIENCES vs EDWARDS LIFESCIENCES LLC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Percutaneously Delivered Prostheses And Tri…, 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 (519 here).

Similar death-typed counts

Nearest other device types by death-typed report count (33 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.