2026 data FDA MAUDE openFDA

Pulmonary Valve Prosthesis 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 Pulmonary Valve Prosthesis Percutaneously D… LIGHT-BOOK · MAUDE

#471 of 1000 · 2,104 reports · 2010–2026

  • BOOK 2,104 reports
  • RANK #471 of 1000
  • DEATH 69 death-typed
  • INJ 1,655 injury-typed
  • MALF 380 malfunction
  • SPAN 2010–2026
  • PEAK 2025: 330
  • PHOTO Device

Nearest event-volume peer: Device, Irrigation, Ocular Surgery (2 report gap)

Pulmonary Valve Prosthesis Percutaneously Delivered sits #471 of 1000 among tracked device types with 2,104 MAUDE reports spanning 2010–2026. 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 3.3% corpus 1.5% · above corpus mean (+1.8 pp)
  • INJ 78.7% corpus 30.4% · above corpus mean (+48.2 pp)
  • MALF 18.1% corpus 64.5% · below corpus mean (-46.4 pp)

Lead product-problem code Insufficient Information is 17% of coded problems · Lead manufacturer MEDTRONIC HEART VALVES DIVISION accounts for 62% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Pulmonary Valve Prosthesis Percutaneously D… in the event-volume neighbourhood

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

reports

What this shows Pulmonary Valve Prosthesis Percutaneously Delivered carries 2,104 MAUDE reports, ranked #471 of 1000.

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

Event Types

Injury 1,655 (78.7%)
Malfunction 380 (18.1%)
Death 69 (3.3%)

Patient Outcomes

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

Required Intervention 1,397 (52.9%)
322 (12.2%)
R 244 (9.2%)
H 161 (6.1%)
Hospitalization 157 (5.9%)
L 98 (3.7%)
Life Threatening 92 (3.5%)
Other 67 (2.5%)
Death 50 (1.9%)
D 19 (0.7%)
Congenital Anomaly 14 (0.5%)
O 12 (0.5%)
C 6 (0.2%)
S 3 (0.1%)

Top Product Problems

Insufficient Information 406
Patient Device Interaction Problem 266
Fracture 258
Adverse Event Without Identified Device or Use Problem 252
Gradient Increase 241
Intravalvular regurgitation 129
Perivalvular Leak 106
Degraded 100
Fluid/Blood Leak 100
Device Stenosis 87
Device Dislodged or Dislocated 83
Malposition of Device 80
Structural Problem 47
Burst Container or Vessel 42
Migration or Expulsion of Device 41
Appropriate Term/Code Not Available 40
Obstruction of Flow 40
Migration 38
Calcified 37
Incomplete Coaptation 36

Yearly Trend

10
2010: 20
11
2011: 41
12
2012: 25
13
2013: 36
14
2014: 48
15
2015: 72
16
2016: 66
17
2017: 96
18
2018: 126
19
2019: 143
20
2020: 112
21
2021: 153
22
2022: 191
23
2023: 253
24
2024: 325
25
2025: 330
26
2026: 67

Related Entities for Pulmonary Valve Prosthesis Percutaneously Delivered

Event Locations

1,251 (59.5%)
I 783 (37.2%)
HOSPITAL 65 (3.1%)
NO INFORMATION 5 (0.2%)

Compare MEDTRONIC HEART VALVES DIVISION vs EDWARDS LIFESCIENCES →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pulmonary Valve Prosthesis Percutaneously D…, 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 (2,104 here).

Similar death-typed counts

Nearest other device types by death-typed report count (69 here), distinct from the volume row.

Disclaimer: MAUDE figures for Pulmonary Valve Prosthesis Percutaneously D… 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 Pulmonary Valve Prosthesis Percutaneously D…; 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.