Devices › Aortic valve, prosthesis, percutaneously delivered
Device brand name · Aortic valve prosthesis percutaneously delivered
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve: medical device reports filed with FDA
3,737 reports name it, 2019–2026. Manufacturer given most often on reports: Edwards Lifesciences. Product code NPT.
- 3,737
- device reports naming the brand
- 0% of all MAUDE reports · about 504 a year
- 714
- reports, 12 months to August 2026
- 743 in the 12 months before
- 8.1%
- classified as malfunction
- 15.2% across the product code
- 14%
- classified as death, as reported
- 523 reports · not verified by FDA
3,737 medical device reports received by FDA name the brand "Edwards SAPIEN 3 Ultra Transcatheter Heart Valve" (aortic valve prosthesis percutaneously delivered); the manufacturer given most often on reports is Edwards Lifesciences; received from February 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
714 reports arrived in the 12 months to August 2026, close to the 743 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 (77.9%), death (14%) and malfunction (8.1%); across all aortic valve, prosthesis, percutaneously delivered reports (product code NPT) death is recorded in 10.1% and malfunction in 15.2%. 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 (19.5%), perivalvular leak (11.4%) and material deformation (7.8%). The patient problems coded most often are dyspnea, heart block and appropriate clinical signs, symptoms and conditions term/code not available. 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 79,063 reports carrying product code NPT. 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 | 729 | 19.5% | 10.2% |
| Perivalvular leak | 426 | 11.4% | 13% |
| Material deformation | 292 | 7.8% | 1.6% |
| Device stenosis | 279 | 7.5% | 2.9% |
| Calcified | 234 | 6.3% | 2.8% |
| Malposition of device | 214 | 5.7% | 5% |
| Migration or expulsion of device | 201 | 5.4% | 2.4% |
| Degraded | 195 | 5.2% | 3% |
| Intravalvular regurgitation | 161 | 4.3% | 3% |
| Gradient increase | 157 | 4.2% | 3.2% |
| Fluid/blood leak | 116 | 3.1% | 2.7% |
| Difficult to open or close | 89 | 2.4% | 1% |
| Material twisted/bent | 49 | 1.3% | 0.5% |
| Patient device interaction problem | 48 | 1.3% | 11.9% |
| Migrationthe device moved from where it was placed | 40 | 1.1% | 0.9% |
| Device dislodged or dislocated | 25 | 0.7% | 8.4% |
| Incomplete coaptation | 24 | 0.6% | 0.7% |
| Patient-device incompatibilitythe device did not suit the patient | 19 | 0.5% | 0.3% |
| Nonstandard device | 18 | 0.5% | 0% |
| Material split, cut or torn | 13 | 0.3% | 1.2% |
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 |
|---|---|---|
| Dyspneashortness of breath | 370 | 9.9% |
| Heart block | 356 | 9.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 266 | 7.1% |
| Heart failure/congestive heart failure | 218 | 5.8% |
| Rupturethe device burst | 183 | 4.9% |
| Foreign body in patientpart of a device left in the patient | 162 | 4.3% |
| Stroke/cva | 106 | 2.8% |
| Obstruction/occlusion | 102 | 2.7% |
| Thrombosis/thrombus | 101 | 2.7% |
| Endocarditis | 69 | 1.8% |
| Ischemia stroke | 65 | 1.7% |
| Hemolysis | 59 | 1.6% |
| Vascular dissection | 56 | 1.5% |
| Aortic valve insufficiency/ regurgitation | 47 | 1.3% |
| Myocardial infarctionheart attack | 43 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve | Product code NPT | All MAUDE reports |
|---|---|---|---|
| Reports | 3,737 | 79,063 | 26,136,888 |
| Share of that pool | — | 4.7% | 0% |
| Classified as death, per 1,000 reports | 140 | 101 | 9 |
| Classified as injury | 77.9% | 74.6% | 36.2% |
| Classified as malfunction | 8.1% | 15.2% | 62.3% |
| Filed by the manufacturer | 99.7% | 99.6% | 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 NPT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Edwards SAPIEN 3 Transcatheter Heart valve | 8,127 | 668 | 9.2% |
| Evolut R Transcatheter Aortic Valve | 6,444 | 521 | 9.6% |
| Evolut Pro Plus Valve | 5,873 | 780 | 12.8% |
| Evolut Fx Valve | 5,267 | 851 | 14.1% |
| Evolut Pro Transcatheter Aortic Valve | 3,668 | 422 | 11% |
| Evolut Fx Plus Valve | 3,448 | 2,316 | 8.9% |
| Edwards COMMANDER DELIVERY SYSTEM | 3,105 | 368 | 12.3% |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve | 2,885 | 1,128 | 11.6% |
| Evolut Fx Dcs | 2,570 | 860 | 10.8% |
| Edwards SAPIEN XT Transcatheter Heart Valve | 2,249 | 48 | 7.6% |
| Navitor Vision | 2,045 | 1,258 | 6.4% |
| SAPIEN 3 Transcatheter Heart Valve | 2,196 | 419 | 6% |
| Corevalve Transcatheter Aortic Valve | 1,669 | 60 | 9.6% |
| Edwards Sapien Transcatheter Heart Valve | 1,947 | 7 | 14.3% |
| Navitor Transcatheter Aortic Valve | 1,382 | 245 | 9% |
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 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve reports
How many FDA reports name Edwards SAPIEN 3 Ultra Transcatheter Heart Valve?
3,737 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 714 in the latest 12 months.
What kinds of events are reported?
injury (77.9%), death (14%) and malfunction (8.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (19.5%), perivalvular leak (11.4%), material deformation (7.8%), device stenosis (7.5%) and calcified (6.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Edwards SAPIEN 3 Ultra Transcatheter Heart 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.