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2026 data FDA MAUDE openFDA

Pulmonic Valved Conduit

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

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FDA MAUDE casebook

openFDA event book Pulmonic Valved Conduit LIGHT-BOOK · MAUDE

#635 of 1000 · 1,133 reports · 2002–2026

  • BOOK 1,133 reports
  • RANK #635 of 1000
  • DEATH 50 death-typed
  • INJ 1,055 injury-typed
  • MALF 27 malfunction
  • SPAN 2002–2026
  • PEAK 2019: 128
  • PHOTO Epidural Anesthesia K…

Nearest event-volume peer: Epidural Anesthesia Kit (3 report gap)

Pulmonic Valved Conduit sits #635 of 1000 among tracked device types with 1,133 MAUDE reports spanning 2002–2026. 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

Pulmonic Valved Conduit carries 93.1% INJURY-coded reports, 62.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.4% corpus 1.5% · above corpus mean (+2.9 pp)
  • INJ 93.1% corpus 30.3% · above corpus mean (+62.8 pp)
  • MALF 2.4% corpus 64.8% · below corpus mean (-62.4 pp)

Lead product-problem code Insufficient Device Problem Information is 38% of coded problems · Lead manufacturer MEDTRONIC HEART VALVES DIVISION accounts for 100% of manufacturer-tagged reports · Top event location I is 64% of location-tagged rows .

Pulmonic Valved Conduit in the event-volume neighbourhood

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

reports

What this shows Pulmonic Valved Conduit carries 1,133 MAUDE reports, ranked #635 of 1000.

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

Event Types

Injury 1,055 (93.1%)
Death 50 (4.4%)
Malfunction 27 (2.4%)
1 (0.1%)

Patient Outcomes

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

Required Intervention 807 (50.7%)
R 252 (15.8%)
Hospitalization 195 (12.2%)
H 147 (9.2%)
L 49 (3.1%)
Death 41 (2.6%)
Life Threatening 36 (2.3%)
25 (1.6%)
Congenital Anomaly 23 (1.4%)
D 7 (0.4%)
Other 5 (0.3%)
C 3 (0.2%)
O 2 (0.1%)

Top Product Problems

Insufficient Device Problem Information 527
Gradient Increase 163
Adverse Event Without Identified Device or Use Problem 102
Calcified 96
Explanted 67
Patient Device Interaction Problem 59
Intravalvular regurgitation 45
Occlusion Within Device 44
Replace 43
Obstruction of Flow 42
Device Stenosis 41
Inadequacy of Device Shape and/or Size 33
Appropriate Device Problem Term/Code Not Available 29
Degraded 20
Device Operates Differently Than Expected 18
Structural Problem 18
Material Deformation 14
Performance 13
Incomplete Coaptation 12
Other (for use when an appropriate device code cannot be identified) 12

Yearly Trend

02
2002: 6
03
2003: 1
04
2004: 16
05
2005: 17
06
2006: 11
07
2007: 16
08
2008: 16
09
2009: 11
10
2010: 15
11
2011: 12
12
2012: 10
13
2013: 10
14
2014: 49
15
2015: 74
16
2016: 105
17
2017: 96
18
2018: 111
19
2019: 128
20
2020: 83
21
2021: 79
22
2022: 67
23
2023: 57
24
2024: 69
25
2025: 41
26
2026: 33

Reports in 2025 (41) held close to the prior two-year average of 63.

Related Entities for Pulmonic Valved Conduit

Top Manufacturers

MEDTRONIC HEART VALVES DIVISION 804
EDWARDS LIFESCIENCES 3

Event Locations

I 720 (63.5%)
296 (26.1%)
HOSPITAL 113 (10.0%)
HOME 3 (0.3%)
INVALID DATA 1 (0.1%)

Compare MEDTRONIC HEART VALVES DIVISION vs EDWARDS LIFESCIENCES →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pulmonic Valved Conduit: 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 (1,133 here).

Epidural Anesthesia Kit 1,130 Prosthesis 1,136 Apparatus, Suction, Patient Care 1,122 Prosthesis, Hip, Hemi-, Femoral, Metal Ball 1,120

Similar death-typed counts

Nearest other device types by death-typed report count (50 here), distinct from the volume row.

Catheter 50 Hexokinase, Glucose 49 Needle, Fistula 49 Prosthesis 49

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Pulmonic Valved Conduit 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 Pulmonic Valved Conduit; 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.