2026 data FDA MAUDE openFDA

Prosthesis, Mitral Valve, Percutaneously Delivered

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 Prosthesis LIGHT-BOOK · MAUDE

#518 of 1000 · 1,717 reports · 2017–2026

  • BOOK 1,717 reports
  • RANK #518 of 1000
  • DEATH 387 death-typed
  • INJ 1,200 injury-typed
  • MALF 130 malfunction
  • SPAN 2017–2026
  • PEAK 2025: 315
  • PHOTO Chair, With Casters

Nearest event-volume peer: Chair, With Casters (2 report gap)

Prosthesis, Mitral Valve, Percutaneously Delivered sits #518 of 1000 among tracked device types with 1,717 MAUDE reports spanning 2017–2026. 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 22.5% corpus 1.5% · above corpus mean (+21.0 pp)
  • INJ 69.9% corpus 30.4% · above corpus mean (+39.5 pp)
  • MALF 7.6% corpus 64.5% · below corpus mean (-56.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 37% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 63% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Prosthesis in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Mitral Valve, Percutaneously Delivered carries 1,717 MAUDE reports, ranked #518 of 1000.

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

Event Types

Injury 1,200 (69.9%)
Death 387 (22.5%)
Malfunction 130 (7.6%)

Patient Outcomes

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

Required Intervention 729 (40.0%)
Other 441 (24.2%)
Death 368 (20.2%)
134 (7.4%)
R 60 (3.3%)
D 24 (1.3%)
Hospitalization 22 (1.2%)
H 13 (0.7%)
Life Threatening 12 (0.7%)
O 8 (0.4%)
L 6 (0.3%)
S 3 (0.2%)
Disability 2 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 723
Insufficient Information 305
Perivalvular Leak 204
Malposition of Device 118
Fluid/Blood Leak 102
Migration or Expulsion of Device 54
Device Stenosis 47
Difficult to Open or Close 47
Degraded 46
Difficult to Remove 42
Gradient Increase 42
Burst Container or Vessel 41
Migration 36
Device Dislodged or Dislocated 32
Calcified 31
Intravalvular regurgitation 25
Incomplete Coaptation 23
Material Split, Cut or Torn 19
Patient Device Interaction Problem 19
Material Rupture 17

Yearly Trend

17
2017: 11
18
2018: 51
19
2019: 30
20
2020: 218
21
2021: 248
22
2022: 213
23
2023: 288
24
2024: 280
25
2025: 315
26
2026: 63

Related Entities for Prosthesis, Mitral Valve, Percutaneously Delivered

Event Locations

1,212 (70.6%)
I 474 (27.6%)
HOSPITAL 26 (1.5%)
NO INFORMATION 4 (0.2%)
OTHER 1 (0.1%)

Compare EDWARDS LIFESCIENCES vs EDWARDS LIFESCIENCES LLC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Prosthesis, 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 (1,717 here).

Similar death-typed counts

Nearest other device types by death-typed report count (387 here), distinct from the volume row.

Disclaimer: MAUDE figures for Prosthesis 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 Prosthesis; 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.