Devices › Pulmonary valve prosthesis percutaneously delivered
Device brand name · Pulmonary valve prosthesis percutaneously deli
Harmony Transcatheter Pulmonary Valve: medical device reports filed with FDA
291 reports name it, 2021–2026. Manufacturer given most often on reports: Medtronic Heart Valves Division. Product code NPV.
- 291
- device reports naming the brand
- 0% of all MAUDE reports · about 59 a year
- 90
- reports, 12 months to August 2026
- 98 in the 12 months before
- 29.6%
- classified as malfunction
- 18% across the product code
- 4.1%
- classified as death, as reported
- 12 reports · not verified by FDA
FDA's MAUDE database holds 291 reports that name the brand "Harmony Transcatheter Pulmonary Valve" (pulmonary valve prosthesis percutaneously deli), received between August 2021 and August 2026; the manufacturer given most often on reports is Medtronic Heart Valves Division. Spellings of one product vary from report to report.
90 reports arrived in the 12 months to August 2026, close to the 98 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 (66.3%), malfunction (29.6%) and death (4.1%); across all pulmonary valve prosthesis percutaneously delivered reports (product code NPV) death is recorded in 3.4% and malfunction in 18%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are patient device interaction problem (52.2%), intravalvular regurgitation (15.1%) and structural problem (14.4%). The patient problems coded most often are non specific ekg/ECG changes, tachycardia and pulmonary valve insufficiency/ 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 2,305 reports carrying product code NPV. 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 |
|---|---|---|---|
| Patient device interaction problem | 152 | 52.2% | 14.4% |
| Intravalvular regurgitation | 44 | 15.1% | 6.9% |
| Structural problem | 42 | 14.4% | 2.6% |
| Gradient increase | 37 | 12.7% | 12.7% |
| Fracturea broken bone | 32 | 11% | 16.3% |
| Perivalvular leak | 24 | 8.2% | 5.3% |
| Device dislodged or dislocated | 23 | 7.9% | 4.3% |
| Thickening of material | 21 | 7.2% | 1.3% |
| Activation failure | 20 | 6.9% | 1.5% |
| Insufficient device problem information | 16 | 5.5% | 19.8% |
| Device stenosis | 11 | 3.8% | 4.9% |
| Migrationthe device moved from where it was placed | 8 | 2.7% | 1.7% |
| Material invagination | 6 | 2.1% | 0.3% |
| Mechanics altered | 5 | 1.7% | 0.3% |
| Difficult or delayed positioning | 3 | 1% | 1.5% |
| Calcified | 2 | 0.7% | 1.7% |
| Degraded | 2 | 0.7% | 5% |
| Difficult to open or close | 2 | 0.7% | 1.6% |
| Fluid/blood leak | 2 | 0.7% | 4.4% |
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 |
|---|---|---|
| Non specific ekg/ECG changes | 53 | 18.2% |
| Tachycardiafast heart rate | 47 | 16.2% |
| Pulmonary valve insufficiency/ regurgitation | 32 | 11% |
| Valvular insufficiency/ regurgitation | 26 | 8.9% |
| Thrombosis/thrombus | 25 | 8.6% |
| Chest painchest pain | 20 | 6.9% |
| Arrhythmia | 17 | 5.8% |
| Transvalvular pressure gradient increased | 16 | 5.5% |
| Tricuspid valve insufficiency/ regurgitation | 16 | 5.5% |
| Endocarditis | 15 | 5.2% |
| Dyspneashortness of breath | 10 | 3.4% |
| Heart failure/congestive heart failure | 10 | 3.4% |
| Bradycardiaslow heart rate | 9 | 3.1% |
| Fever | 9 | 3.1% |
| Cardiac arrestthe heart stopped | 8 | 2.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Harmony Transcatheter Pulmonary Valve | Product code NPV | All MAUDE reports |
|---|---|---|---|
| Reports | 291 | 2,305 | 26,136,888 |
| Share of that pool | — | 12.6% | 0% |
| Classified as death, per 1,000 reports | 41 | 34 | 9 |
| Classified as injury | 66.3% | 78.6% | 36.2% |
| Classified as malfunction | 29.6% | 18% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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."
Other brands with product code NPV
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Melody Transcatheter Pulmonary Valve | 705 | 106 | 5.7% |
| Melody Transcather Pulmonary Valve | 238 | 0 | 5.5% |
| Melody Transcather Pulmonary | 248 | 0 | 4% |
| Edwards SAPIEN 3 Transcatheter Heart valve | 8,127 | 668 | 9.2% |
| SAPIEN 3 Transcatheter Heart Valve | 2,196 | 419 | 6% |
| Edwards SAPIEN XT Transcatheter Heart Valve | 2,249 | 48 | 7.6% |
| Edwards COMMANDER DELIVERY SYSTEM | 3,105 | 368 | 12.3% |
| Commander Delivery System | 1,429 | 306 | 10.6% |
| Edwards Sapien 3 Transcatheter | 1,200 | 83 | 6.5% |
| Edwards SAPIEN 3 Transcatheter Heath Valve | 753 | 67 | 14.9% |
| SAPIEN XT Transcatheter Heart Valve | 184 | 31 | 2.7% |
| Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve | 266 | 132 | 5.3% |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve | 3,737 | 714 | 14% |
| Edwards Commander Delivery | 220 | 4 | 12.3% |
| Edwards Sapien Transcatheter Heart Valve | 1,947 | 7 | 14.3% |
Ordered by report count for navigation only. 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 also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Harmony Transcatheter Pulmonary Valve reports
How many FDA reports name Harmony Transcatheter Pulmonary Valve?
291 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 90 in the latest 12 months.
What kinds of events are reported?
injury (66.3%), malfunction (29.6%) and death (4.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
patient device interaction problem (52.2%), intravalvular regurgitation (15.1%), structural problem (14.4%), gradient increase (12.7%) and fracture (11%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Harmony Transcatheter Pulmonary Valve 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.