Devices › Pulmonic valved conduit
Device brand name · Conduit valved pulmonic
Contegra: medical device reports filed with FDA
776 reports name it, 2011–2026. Manufacturer given most often on reports: Medtronic Heart Valves Division. Product code MWH.
- 776
- device reports naming the brand
- 0% of all MAUDE reports · about 53 a year
- 43
- reports, 12 months to August 2026
- 42 in the 12 months before
- 1%
- classified as malfunction
- 2.4% across the product code
- 2.4%
- classified as death, as reported
- 19 reports · not verified by FDA
776 medical device reports received by FDA name the brand "Contegra" (conduit valved pulmonic); the manufacturer given most often on reports is Medtronic Heart Valves Division; received from October 2011 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
43 reports arrived in the 12 months to August 2026, close to the 42 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (96.5%), death (2.4%) and malfunction (1%); across all pulmonic valved conduit reports (product code MWH) death is recorded in 4.4% and malfunction in 2.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (61.7%), gradient increase (13.3%) and calcified (8.1%). The patient problems coded most often are pulmonary valve stenosis, pulmonary valve insufficiency/ regurgitation and pulmonary regurgitation. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,138 reports carrying product code MWH. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Insufficient device problem information | 479 | 61.7% | 46.5% |
| Gradient increase | 103 | 13.3% | 14.5% |
| Calcified | 63 | 8.1% | 8.5% |
| Patient device interaction problem | 54 | 7% | 5.5% |
| Device stenosis | 43 | 5.5% | 4% |
| Intravalvular regurgitation | 40 | 5.2% | 4.2% |
| Inadequacy of device shape and/or size | 21 | 2.7% | 2.9% |
| Occlusion within devicethe device blocked | 18 | 2.3% | 3.9% |
| Obstruction of flow | 14 | 1.8% | 3.7% |
| Degraded | 12 | 1.5% | 1.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 8 | 1% | 1.6% |
| Incomplete coaptation | 7 | 0.9% | 1.1% |
| Structural problem | 5 | 0.6% | 1.6% |
| Material deformation | 4 | 0.5% | 1.2% |
| Biocompatibility | 3 | 0.4% | 0.3% |
| Material split, cut or torn | 3 | 0.4% | 0.4% |
| Partial blockage | 3 | 0.4% | 0.5% |
| Patient-device incompatibilitythe device did not suit the patient | 3 | 0.4% | 0.3% |
| Reflux within device | 3 | 0.4% | 0.3% |
| Stretched | 3 | 0.4% | 0.6% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Pulmonary valve stenosis | 262 | 33.8% |
| Pulmonary valve insufficiency/ regurgitation | 77 | 9.9% |
| Pulmonary regurgitation | 59 | 7.6% |
| Endocarditis | 58 | 7.5% |
| Calcium deposits/calcification | 39 | 5% |
| Pulmonary insufficiency | 34 | 4.4% |
| Stenosis | 33 | 4.3% |
| Obstruction/occlusion | 22 | 2.8% |
| Deaththe patient died; cause not stated by this term | 15 | 1.9% |
| Regurgitation, valvular | 14 | 1.8% |
| Non specific ekg/ECG changes | 13 | 1.7% |
| Insufficiency, valvular | 12 | 1.5% |
| Heart block | 10 | 1.3% |
| Dyspneashortness of breath | 9 | 1.2% |
| Fever | 9 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Contegra | Product code MWH | All MAUDE reports |
|---|---|---|---|
| Reports | 776 | 1,138 | 26,136,888 |
| Share of that pool | — | 68.2% | 0% |
| Classified as death, per 1,000 reports | 24 | 44 | 9 |
| Classified as injury | 96.5% | 93.1% | 36.2% |
| Classified as malfunction | 1% | 2.4% | 62.3% |
| Filed by the manufacturer | 99.6% | 98.1% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Questions about Contegra reports
How many FDA reports name Contegra?
776 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 43 in the latest 12 months.
What kinds of events are reported?
injury (96.5%), death (2.4%) and malfunction (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (61.7%), gradient increase (13.3%), calcified (8.1%), patient device interaction problem (7%) and device stenosis (5.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Contegra was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.