Devices › Aortic valve, prosthesis, percutaneously delivered
Device brand name · Aortic valve prosthesis percutaneously delivered
Edwards SAPIEN 3 Transcatheter Heart valve: medical device reports filed with FDA
8,127 reports name it, 2015–2026. Manufacturer given most often on reports: Edwards Lifesciences. Product code NPT.
- 8,127
- device reports naming the brand
- 0% of all MAUDE reports · about 733 a year
- 668
- reports, 12 months to August 2026
- 721 in the 12 months before
- 2.2%
- classified as malfunction
- 15.2% across the product code
- 9.2%
- classified as death, as reported
- 749 reports · not verified by FDA
FDA's MAUDE database holds 8,127 reports that name the brand "Edwards SAPIEN 3 Transcatheter Heart valve" (aortic valve prosthesis percutaneously delivered), received between June 2015 and August 2026; the manufacturer given most often on reports is Edwards Lifesciences. Spellings of one product vary from report to report.
668 reports arrived in the 12 months to August 2026, close to the 721 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 (88.6%), death (9.2%) and malfunction (2.2%); 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 (10.5%), perivalvular leak (9.3%) and degraded (7.4%). The patient problems coded most often are complete heart block, heart block and dyspnea. 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 | 857 | 10.5% | 10.2% |
| Perivalvular leak | 755 | 9.3% | 13% |
| Degraded | 603 | 7.4% | 3% |
| Calcified | 566 | 7% | 2.8% |
| Malposition of device | 513 | 6.3% | 5% |
| Fluid/blood leak | 385 | 4.7% | 2.7% |
| Device stenosis | 350 | 4.3% | 2.9% |
| Gradient increase | 288 | 3.5% | 3.2% |
| Device dislodged or dislocated | 217 | 2.7% | 8.4% |
| Migration or expulsion of device | 165 | 2% | 2.4% |
| Difficult to open or close | 148 | 1.8% | 1% |
| Incomplete coaptation | 118 | 1.5% | 0.7% |
| Leak/splashthe device leaked | 103 | 1.3% | 1% |
| Migrationthe device moved from where it was placed | 94 | 1.2% | 0.9% |
| Intravalvular regurgitation | 76 | 0.9% | 3% |
| Material deformation | 59 | 0.7% | 1.6% |
| Positioning problem | 58 | 0.7% | 0.7% |
| Particulates | 34 | 0.4% | 0.6% |
| Patient-device incompatibilitythe device did not suit the patient | 33 | 0.4% | 0.3% |
| Patient device interaction problem | 32 | 0.4% | 11.9% |
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 |
|---|---|---|
| Complete heart block | 746 | 9.2% |
| Heart block | 721 | 8.9% |
| Dyspneashortness of breath | 566 | 7% |
| Arrhythmia | 501 | 6.2% |
| Rupturethe device burst | 480 | 5.9% |
| Aortic regurgitation | 454 | 5.6% |
| Injurya physical injury | 451 | 5.5% |
| Heart failure/congestive heart failure | 391 | 4.8% |
| Stroke/cva | 352 | 4.3% |
| Infarction, cerebral | 271 | 3.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 263 | 3.2% |
| Obstruction/occlusion | 250 | 3.1% |
| Deaththe patient died; cause not stated by this term | 231 | 2.8% |
| Occlusion | 220 | 2.7% |
| Calcium deposits/calcification | 185 | 2.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Edwards SAPIEN 3 Transcatheter Heart valve | Product code NPT | All MAUDE reports |
|---|---|---|---|
| Reports | 8,127 | 79,063 | 26,136,888 |
| Share of that pool | — | 10.3% | 0% |
| Classified as death, per 1,000 reports | 92 | 101 | 9 |
| Classified as injury | 88.6% | 74.6% | 36.2% |
| Classified as malfunction | 2.2% | 15.2% | 62.3% |
| Filed by the manufacturer | 100% | 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 |
|---|---|---|---|
| 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% |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve | 3,737 | 714 | 14% |
| 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 Transcatheter Heart valve reports
How many FDA reports name Edwards SAPIEN 3 Transcatheter Heart valve?
8,127 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 668 in the latest 12 months.
What kinds of events are reported?
injury (88.6%), death (9.2%) and malfunction (2.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (10.5%), perivalvular leak (9.3%), degraded (7.4%), calcified (7%) and malposition of device (6.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). 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 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.