Edwards SAPIEN 3 Ultra Transcatheter Heart Valve medical device reports that FDA received
- Name type
- Device brand name, as written on reports
- Generic name
- Aortic valve prosthesis percutaneously delivered
- Device type
- Aortic valve, prosthesis, percutaneously delivered (product code NPT)
- Manufacturer given most often on reports
- Edwards Lifesciences
What a report is
A report is not proof that the device was the cause of the event.
FDA says:
Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .
FDA also says:
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.
Source: openFDA, Device Adverse Event Overview. The site read the page on .
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
Reports on file
From February 2019 to September 2026, FDA received 3,758 medical device reports that name the brand Edwards SAPIEN 3 Ultra Transcatheter Heart Valve. A brand name is as the reporter or the manufacturer wrote it, so one product can have more than one spelling.
FDA received 673 reports in the 12 months to September 2026 and 755 in the 12 months before. FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Of the 3,444,740 device reports that FDA received in the 12 months to September 2026, 673 (under 0.1%) name the brand Edwards SAPIEN 3 Ultra Transcatheter Heart Valve. Manufacturer reports were 99.7% of the reports that name this brand and 94.9% of all device reports.
The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.
What an MDR is
A medical device report: one submission to FDA about one event. It has the brand name, the generic name, the manufacturer, the product code, the event type and coded problems. Manufacturers and user facilities must send reports.
Data version
openFDA MAUDE release of 23 Oct 2026. Reports received through 30 Sep 2026.
Since the last update
FDA says:
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
The latest update of the FDA data, recorded on , changed no count of this page.
- In April to June 2026, FDA received 162 reports that name the brand Edwards SAPIEN 3 Ultra Transcatheter Heart Valve.
- In January to March 2026, FDA received 149.
- In April to June 2025, FDA received 187.
April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.
Event types by year
The event type is the classification that the reporter gave. The four terms are FDA's.
FDA says:
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Reports that name Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, by event type and by the year in which FDA received them
The table continues to the right.
| Year | Reports | Death | Injury | Malfunction | Other | Not given |
|---|---|---|---|---|---|---|
| 2019 | 25 | 4 | 19 | 2 | 0 | 0 |
| 2020 | 114 | 24 | 56 | 34 | 0 | 0 |
| 2021 | 338 | 73 | 210 | 55 | 0 | 0 |
| 2022 | 522 | 74 | 392 | 56 | 0 | 0 |
| 2023 | 686 | 101 | 531 | 54 | 0 | 0 |
| 2024 | 856 | 128 | 683 | 45 | 0 | 0 |
| 2025 | 753 | 91 | 624 | 38 | 0 | 0 |
| 2026 | 464 | 28 | 416 | 20 | 0 | 0 |
An event type in a report is not proof that the device was the cause. FDA does not verify the event type.
Malfunction
A malfunction report says that the device did not do what it was made to do. It can be with or without harm to a person.
Reports by month
FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
| Event type | Reports | Share | Share as a bar |
|---|---|---|---|
| Death | 523 | 13.9% | |
| Injury | 2,931 | 78% | |
| Malfunction | 304 | 8.1% | |
| Other | 0 | 0% | |
| Not given | 0 | 0% |
| Report source | Reports | Share | Share as a bar |
|---|---|---|---|
| Manufacturer report | 3,747 | 99.7% | |
| Voluntary report | 2 | 0.1% | |
| User facility report | 0 | 0% | |
| Distributor report | 0 | 0% | |
| Not given | 9 | 0.2% |
Each share is of the 3,758 reports that name this brand, not of the devices in use.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Insufficient device problem information | 730 | 19.4% |
| Perivalvular leak | 429 | 11.4% |
| Material deformation | 293 | 7.8% |
| Device stenosis | 287 | 7.6% |
| Calcified | 238 | 6.3% |
| Malposition of device | 214 | 5.7% |
| Migration or expulsion of device | 201 | 5.3% |
| Degraded | 196 | 5.2% |
| Intravalvular regurgitation | 164 | 4.4% |
| Gradient increase | 159 | 4.2% |
| Fluid/blood leak | 116 | 3.1% |
| Difficult to open or close | 89 | 2.4% |
| Material twisted/bent | 49 | 1.3% |
| Patient device interaction problem | 49 | 1.3% |
| Migrationthe device moved from where it was placed | 40 | 1.1% |
| Incomplete coaptation | 26 | 0.7% |
| Device dislodged or dislocated | 25 | 0.7% |
| Patient-device incompatibilitythe device did not suit the patient | 19 | 0.5% |
| Nonstandard device | 18 | 0.5% |
| Material split, cut or torn | 13 | 0.3% |
These are the device problem codes of FDA, as written on the report. One report can have more than one code. The table leaves out general codes such as "no apparent adverse event".
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Dyspneashortness of breath | 378 | 10.1% |
| Heart block | 356 | 9.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 266 | 7.1% |
| Heart failure/congestive heart failure | 224 | 6% |
| Rupturethe device burst | 184 | 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 | 44 | 1.2% |
Patient problem codes are mainly in reports sent since 2019, and the field is often empty.
Pages near this one
- Edwards SAPIEN 3 Ultra RESILIA valve same device type
- Edwards Sapien 3 Ultra Transcatheter Heart Valve System same device type
- Edwards Sapien 3 Ultra Resilia Transcatheter Heart Valve System same device type
- Edwards Sapien 3 Ultra Valve same device type
- Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve same device type
- Edwards Sapien Transcatheter Heart Valve same device type
- Edwards Sapien 3 Ultra same device type
- Edwards SAPIEN XT Transcatheter Heart Valve same device type
- Edwards SAPIEN 3 Transcatheter Heath Valve next in the A to Z list
- Edwards Transfemoral Balloon Catheter next in the A to Z list
- Edwards Sapien 3 Transcatheter Heart Valve Thv next in the A to Z list
- Edwards Transfemoral Esheath Unknown next in the A to Z list
These links are for navigation. No count selected them. The page of the device type lists each brand name with product code NPT.
Official pages
- Medical Device Reporting (MDR): How to Report Medical Device ProblemsThe FDA page that tells how to report a problem with a medical device.
- MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
- Manufacturer and User Facility Device Experience (MAUDE) DatabaseThe search page of FDA for the device reports.
The site checked these addresses on . The links open in a new tab.
Cite this page
Reported Reactions. Edwards SAPIEN 3 Ultra Transcatheter Heart Valve: medical device reports that FDA received. https://reportedreactions.com/device/edwards-sapien-3-ultra-transcatheter-heart-valve/ Source: U.S. Food and Drug Administration, openFDA Device Adverse Event (MAUDE) files, release of . Reports received through .
Where the data come from
The counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. Brand names, generic names and manufacturer names are as written on the reports. The names of the product codes come from the device classification of FDA.
A report is in the count when a device in it has this brand name, after the site removes differences of punctuation and capital letters. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.
Questions
Do these reports show that Edwards SAPIEN 3 Ultra Transcatheter Heart Valve was at fault?
No. FDA says:
The submission of an MDR itself does not necessarily demonstrate that the device caused or contributed to the adverse outcome or event.
Source: FDA Center for Devices and Radiological Health, About Manufacturer and User Facility Device Experience (MAUDE) Database. Content current as of . The site read the page on .
Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
What event types do the reports record?
Death (523), injury (2,931) and malfunction (304). The event type is the classification that the reporter gave: death, injury, malfunction or other. FDA does not verify it.
Who sent these reports?
Manufacturer reports (99.7%) and voluntary reports (0.1%). These are the sources of the reports that name this brand.
Some reports come directly from user facilities (like hospitals) or device importers (distributors), while others come directly from manufacturers.
Source: openFDA, Device Adverse Event Overview. The site read the page on .
How does a person report a problem with a medical device?
FDA runs MedWatch, a program that takes voluntary reports about medical devices. The guide on how to report has the links.