Devices › Aortic valve, prosthesis, percutaneously delivered
Device brand name · Aortic valve prosthesis percutaneously delivered
Edwards Expandable Introducer Sheath Set: medical device reports filed with FDA
621 reports name it, 2014–2024. Manufacturer given most often on reports: Edwards Lifesciences. Product code NPT.
- 621
- device reports naming the brand
- 0% of all MAUDE reports · about 52 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 18.8%
- classified as malfunction
- 15.2% across the product code
- 2.9%
- classified as death, as reported
- 18 reports · not verified by FDA
FDA's MAUDE database holds 621 reports that name the brand "Edwards Expandable Introducer Sheath Set" (aortic valve prosthesis percutaneously delivered), received between July 2014 and February 2024; the manufacturer given most often on reports is Edwards Lifesciences. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in 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 (78.3%), malfunction (18.8%) and death (2.9%); 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 material split, cut or torn (6.6%), material separation (5.3%) and torn material (4.7%). The patient problems coded most often are vascular dissection, injury and intimal dissection. 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 |
|---|---|---|---|
| Material split, cut or torn | 41 | 6.6% | 1.2% |
| Material separation | 33 | 5.3% | 1.1% |
| Torn material | 29 | 4.7% | 0.3% |
| Difficult to removethe device was hard to remove | 25 | 4% | 2.3% |
| Difficult to insertthe device was hard to insert | 23 | 3.7% | 0.4% |
| Difficult to advance | 22 | 3.5% | 1.2% |
| Split | 21 | 3.4% | 0% |
| Physical resistance/sticking | 19 | 3.1% | 0.5% |
| Physical resistance | 15 | 2.4% | 0% |
| Material rupture | 11 | 1.8% | 0.8% |
| Insufficient device problem information | 9 | 1.4% | 10.2% |
| Delamination | 8 | 1.3% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 8 | 1.3% | 0.2% |
| Failure to advance | 8 | 1.3% | 0.7% |
| Breakthe device broke | 6 | 1% | 0.2% |
| Leak/splashthe device leaked | 6 | 1% | 1% |
| Material deformation | 6 | 1% | 1.6% |
| Detachment of device or device componentpart of the device came off | 5 | 0.8% | 0.9% |
| Activation, positioning or separation problem | 4 | 0.6% | 0.2% |
| Deformation due to compressive stress | 4 | 0.6% | 0.2% |
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 |
|---|---|---|
| Vascular dissection | 211 | 34% |
| Injurya physical injury | 86 | 13.8% |
| Intimal dissection | 52 | 8.4% |
| Rupturethe device burst | 41 | 6.6% |
| Perforation of vessels | 23 | 3.7% |
| Blood loss | 22 | 3.5% |
| Hemorrhage/blood loss/bleeding | 19 | 3.1% |
| Vascular system (circulation), impaired | 14 | 2.3% |
| Occlusion | 12 | 1.9% |
| Deaththe patient died; cause not stated by this term | 11 | 1.8% |
| Hematomaa collection of blood under the skin or in tissue | 11 | 1.8% |
| Calcium deposits/calcification | 10 | 1.6% |
| Pseudoaneurysm | 9 | 1.4% |
| Stenosis | 8 | 1.3% |
| Perforation | 7 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Edwards Expandable Introducer Sheath Set | Product code NPT | All MAUDE reports |
|---|---|---|---|
| Reports | 621 | 79,063 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 29 | 101 | 9 |
| Classified as injury | 78.3% | 74.6% | 36.2% |
| Classified as malfunction | 18.8% | 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 |
|---|---|---|---|
| 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% |
| 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% |
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 Expandable Introducer Sheath Set reports
How many FDA reports name Edwards Expandable Introducer Sheath Set?
621 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (78.3%), malfunction (18.8%) and death (2.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material split, cut or torn (6.6%), material separation (5.3%), torn material (4.7%), difficult to remove (4%) and difficult to insert (3.7%). 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 Edwards Expandable Introducer Sheath Set 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.