Devices › Replacement heart-valve
Device brand name · Replacement heart valve
Carpentier-Edwards Perimount Theon Pericardial Bioprosthesis: medical device reports filed with FDA
1,643 reports name it, 2009–2026. Manufacturer given most often on reports: Edwards Lifesciences. Product code DYE.
- 1,643
- device reports naming the brand
- 0% of all MAUDE reports · about 94 a year
- 46
- reports, 12 months to August 2026
- 88 in the 12 months before
- 3%
- classified as malfunction
- 3.5% across the product code
- 3.9%
- classified as death, as reported
- 64 reports · not verified by FDA
1,643 medical device reports received by FDA name the brand "Carpentier-Edwards Perimount Theon Pericardial Bioprosthesis" (replacement heart valve); the manufacturer given most often on reports is Edwards Lifesciences; received from January 2009 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
46 reports arrived in the 12 months to August 2026, down 48% from 88 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 (92.9%), death (3.9%) and malfunction (3%); across all replacement heart-valve reports (product code DYE) death is recorded in 3.6% and malfunction in 3.5%. 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 (37.7%), gradient increase (15.2%) and calcified (12.1%). The patient problems coded most often are mitral valve stenosis, mitral regurgitation and aortic valve stenosis. 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 37,240 reports carrying product code DYE. 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 | 620 | 37.7% | 38.8% |
| Gradient increase | 249 | 15.2% | 16.5% |
| Calcified | 199 | 12.1% | 14.1% |
| Degraded | 188 | 11.4% | 12.8% |
| Fluid/blood leak | 141 | 8.6% | 6.6% |
| Incomplete coaptation | 124 | 7.5% | 4.7% |
| Perivalvular leak | 81 | 4.9% | 4.2% |
| Device stenosis | 64 | 3.9% | 7.1% |
| Difficult to open or close | 33 | 2% | 1.6% |
| Patient device interaction problem | 33 | 2% | 3.5% |
| Inadequacy of device shape and/or size | 18 | 1.1% | 1% |
| Structural problem | 17 | 1% | 0.8% |
| Intravalvular regurgitation | 16 | 1% | 3.2% |
| Deterioration of prosthesis | 9 | 0.5% | 0.6% |
| Restricted flow rate | 9 | 0.5% | 0.3% |
| Patient-device incompatibilitythe device did not suit the patient | 6 | 0.4% | 0.5% |
| Leak/splashthe device leaked | 5 | 0.3% | 0.5% |
| Defective devicethe device was defective | 4 | 0.2% | 0.2% |
| Detachment of device or device componentpart of the device came off | 4 | 0.2% | 0.2% |
| Thickening of material | 4 | 0.2% | 0.4% |
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 |
|---|---|---|
| Mitral valve stenosis | 368 | 22.4% |
| Mitral regurgitation | 210 | 12.8% |
| Aortic valve stenosis | 166 | 10.1% |
| Heart failure/congestive heart failure | 151 | 9.2% |
| Aortic regurgitation | 117 | 7.1% |
| Dyspneashortness of breath | 113 | 6.9% |
| Endocarditis | 112 | 6.8% |
| Stenosis | 92 | 5.6% |
| Regurgitation | 76 | 4.6% |
| Deaththe patient died; cause not stated by this term | 61 | 3.7% |
| Aortic insufficiency | 28 | 1.7% |
| Calcium deposits/calcification | 28 | 1.7% |
| Tricuspid regurgitation | 28 | 1.7% |
| Corneal pannus | 27 | 1.6% |
| Pulmonary regurgitation | 26 | 1.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Carpentier-Edwards Perimount Theon Pericardial Bioprosthesis | Product code DYE | All MAUDE reports |
|---|---|---|---|
| Reports | 1,643 | 37,240 | 26,136,888 |
| Share of that pool | — | 4.4% | 0% |
| Classified as death, per 1,000 reports | 39 | 36 | 9 |
| Classified as injury | 92.9% | 92.7% | 36.2% |
| Classified as malfunction | 3% | 3.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.2% | 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 DYE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis | 8,192 | 495 | 2.6% |
| Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis | 3,903 | 233 | 1% |
| Carpentier-Edwards Perimount Magna Pericardial Bioprosthesis | 3,518 | 53 | 7.7% |
| Carpentier-Edwards Perimount Rsr Pericardial Bioprosthesis | 3,288 | 13 | 3.3% |
| Mosaic Aortic Bioprosthetic Heart Valve | 3,406 | 405 | 2.8% |
| Carpentier-Edwards PERIMOUNT Plus Pericardial Bioprosthesis | 2,878 | 18 | 8.7% |
| Mosaic | 2,216 | 131 | 0.5% |
| Carpentier-Edwards Perimount Aortic Pericardial Bioprosthesis | 864 | 7 | 7.1% |
| Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprostheses | 824 | 0 | 3.8% |
| Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis | 808 | 1 | 12.9% |
| Mosaic Mitral Bioprosthetic Heart Valve | 1,534 | 154 | 6.4% |
| Ni | 32,939 | 1,587 | 1.8% |
| Carpentier-Edwards Perimount Magna Aortic Bioprosthesis | 1,324 | 11 | 27.1% |
| Carpentier-Edwards Bioprosthesis | 1,055 | 3 | 5% |
| Mosaic Porcine Heart Valve | 311 | 11 | 0.6% |
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 Carpentier-Edwards Perimount Theon Pericardial Bioprosthesis reports
How many FDA reports name Carpentier-Edwards Perimount Theon Pericardial Bioprosthesis?
1,643 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 46 in the latest 12 months.
What kinds of events are reported?
injury (92.9%), death (3.9%) and malfunction (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (37.7%), gradient increase (15.2%), calcified (12.1%), degraded (11.4%) and fluid/blood leak (8.6%). 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 Carpentier-Edwards Perimount Theon Pericardial Bioprosthesis 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.