What are FDA adverse event reports for Pulmonic Valved Conduit?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Pulmonic Valved Conduit, there are 1,107 total reports including 48 death reports and 1,034 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Pulmonic Valved Conduit?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Pulmonic Valved Conduit

Name: Pulmonic Valved Conduit - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

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

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Pulmonic Valved Conduit LIGHT-BOOK · MAUDE

#627 of 1000 · 1,107 reports · 2002–2026

BOOK 1,107 reports
RANK #627 of 1000
DEATH 48 death-typed
INJ 1,034 injury-typed
MALF 24 malfunction
SPAN 2002–2026
PEAK 2019: 128
PHOTO Agent

Nearest event-volume peer: Agent, Bulking, Injectable For Gastro-Urology Use (3 report gap)

Pulmonic Valved Conduit sits #627 of 1000 among tracked device types with 1,107 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 →

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 4.3% corpus 1.5% · above corpus mean (+2.8 pp)
INJ 93.4% corpus 30.4% · above corpus mean (+63.0 pp)
MALF 2.2% corpus 64.5% · below corpus mean (-62.3 pp)

Lead product-problem code Insufficient Information is 46% of coded problems · Lead manufacturer MEDTRONIC HEART VALVES DIVISION accounts for 100% of manufacturer-tagged reports · Top event location I is 65% of location-tagged rows .

Bed

1,114
Pulmonic Valv… (this)

1,107
Agent

1,104
Intervertebra…

1,103
Epidural Anes…

1,100
Dilator

1,095

What this shows Pulmonic Valved Conduit carries 1,107 MAUDE reports, ranked #627 of 1000.

Event Types

Injury 1,034 (93.4%)

Death 48 (4.3%)

Malfunction 24 (2.2%)

1 (0.1%)

Patient Outcomes

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

Required Intervention 793 (51.4%)

R 245 (15.9%)

Hospitalization 190 (12.3%)

H 136 (8.8%)

L 43 (2.8%)

Death 40 (2.6%)

Life Threatening 34 (2.2%)

Congenital Anomaly 23 (1.5%)

22 (1.4%)

D 6 (0.4%)

Other 5 (0.3%)

C 3 (0.2%)

O 2 (0.1%)

Yearly Trend

2002: 6

2003: 1

2004: 16

2005: 17

2006: 11

2007: 16

2008: 16

2009: 11

2010: 15

2011: 12

2012: 10

2013: 10

2014: 49

2015: 74

2016: 105

2017: 96

2018: 111

2019: 128

2020: 83

2021: 79

2022: 67

2023: 57

2024: 69

2025: 41

2026: 7

Top Manufacturers

MEDTRONIC HEART VALVES DIVISION 781

EDWARDS LIFESCIENCES 3

Event Locations

I 720 (65.0%)

271 (24.5%)

HOSPITAL 112 (10.1%)

HOME 3 (0.3%)

INVALID DATA 1 (0.1%)

Compare MEDTRONIC HEART VALVES DIVISION vs EDWARDS LIFESCIENCES →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pulmonic Valved Conduit, 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 (1,107 here).

Agent 1,104 Intervertebral Fusion Device With Bone Graft 1,103 Bed, Flotation Therapy, Powered 1,114 Epidural Anesthesia Kit 1,100

Similar death-typed counts

Nearest other device types by death-typed report count (48 here), distinct from the volume row.

Bone Cement, Antibiotic 47 Control, Pump Speed, Cardiopulmonary Bypass 47 Hexokinase, Glucose 49 Needle, Fistula 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.

Pulmonic Valved Conduit

Event-type mix vs corpus