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

#467 of 1000 · 2,280 reports · 2010–2026

  • BOOK 2,280 reports
  • RANK #467 of 1000
  • DEATH 77 death-typed
  • INJ 1,791 injury-typed
  • MALF 412 malfunction
  • SPAN 2010–2026
  • PEAK 2025: 330
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive (4 report gap)

Pulmonary Valve Prosthesis Percutaneously Delivered sits #467 of 1000 among tracked device types with 2,280 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 →

Injury-coded reports run above the device-type norm

Pulmonary Valve Prosthesis Percutaneously D… carries 78.6% INJURY-coded reports, 48.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.4% corpus 1.5% · above corpus mean (+1.9 pp)
  • INJ 78.6% corpus 30.3% · above corpus mean (+48.3 pp)
  • MALF 18.1% corpus 64.8% · below corpus mean (-46.8 pp)

Lead product-problem code Insufficient Device Problem Information is 16% of coded problems · Lead manufacturer MEDTRONIC HEART VALVES DIVISION accounts for 57% of manufacturer-tagged reports · Top event location is 63% 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 2,280 MAUDE reports, ranked #467 of 1000.

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

Event Types

Injury 1,791 (78.6%)
Malfunction 412 (18.1%)
Death 77 (3.4%)

Patient Outcomes

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

Required Intervention 1,501 (52.6%)
354 (12.4%)
R 262 (9.2%)
H 174 (6.1%)
Hospitalization 170 (6.0%)
L 114 (4.0%)
Life Threatening 100 (3.5%)
Other 68 (2.4%)
Death 55 (1.9%)
D 22 (0.8%)
Congenital Anomaly 14 (0.5%)
O 11 (0.4%)
C 6 (0.2%)
S 3 (0.1%)

Top Product Problems

Insufficient Device Problem Information 455
Fracture 374
Patient Device Interaction Problem 326
Adverse Event Without Identified Device or Use Problem 289
Gradient Increase 289
Intravalvular regurgitation 155
Perivalvular Leak 122
Degraded 112
Device Stenosis 109
Fluid/Blood Leak 103
Device Dislodged or Dislocated 98
Malposition of Device 87
Structural Problem 64
Appropriate Device Problem Term/Code Not Available 49
Migration or Expulsion of Device 49
Burst Container or Vessel 48
Obstruction of Flow 41
Calcified 40
Migration 40
Activation Failure 39

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: 243

Reports in 2025 (330) held close to the prior two-year average of 289.

Related Entities for Pulmonary Valve Prosthesis Percutaneously Delivered

Event Locations

1,427 (62.6%)
I 783 (34.3%)
HOSPITAL 65 (2.9%)
NO INFORMATION 5 (0.2%)

Compare MEDTRONIC HEART VALVES DIVISION vs EDWARDS LIFESCIENCES →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pulmonary Valve Prosthesis Percutaneously D…: 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 (2,280 here).

Similar death-typed counts

Nearest other device types by death-typed report count (77 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.