Devices › Replacement heart-valve
Device brand name · Tissue heart valve
Mitroflow Aortic Pericardial Heart Valve: medical device reports filed with FDA
328 reports name it, 2008–2023. Manufacturer given most often on reports: Sorin Group Canada. Product code DYE.
- 328
- device reports naming the brand
- 0% of all MAUDE reports · about 18 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.8%
- classified as malfunction
- 3.5% across the product code
- 16.8%
- classified as death, as reported
- 55 reports · not verified by FDA
328 medical device reports received by FDA name the brand "Mitroflow Aortic Pericardial Heart Valve" (tissue heart valve); the manufacturer given most often on reports is Sorin Group Canada; received from April 2008 to August 2023. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (59.8%), other (21.6%) and death (16.8%); 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 (31.4%), calcified (22.3%) and gradient increase (11.9%). The patient problems coded most often are aortic valve stenosis, calcium deposits/calcification and death. 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 | 103 | 31.4% | 38.8% |
| Calcified | 73 | 22.3% | 14.1% |
| Gradient increase | 39 | 11.9% | 16.5% |
| Material deformation | 32 | 9.8% | 0.2% |
| Occlusion within devicethe device blocked | 20 | 6.1% | 0.1% |
| Degraded | 19 | 5.8% | 12.8% |
| Material too rigid or stiff | 18 | 5.5% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 14 | 4.3% | 0.1% |
| Material disintegration | 14 | 4.3% | 0% |
| Incomplete coaptation | 13 | 4% | 4.7% |
| Perivalvular leak | 8 | 2.4% | 4.2% |
| Leak/splashthe device leaked | 6 | 1.8% | 0.5% |
| Torn material | 3 | 0.9% | 0.3% |
| Inadequacy of device shape and/or size | 2 | 0.6% | 1% |
| Material integrity problema problem with the device material | 2 | 0.6% | 0.1% |
| Device contamination with chemical or other material | 1 | 0.3% | 0% |
| Device inoperablethe device could not be used | 1 | 0.3% | 0% |
| Difficult to fold, unfold or collapse | 1 | 0.3% | 0% |
| Difficult to removethe device was hard to remove | 1 | 0.3% | 0% |
| Explanted | 1 | 0.3% | 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 |
|---|---|---|
| Aortic valve stenosis | 65 | 19.8% |
| Calcium deposits/calcification | 51 | 15.5% |
| Deaththe patient died; cause not stated by this term | 42 | 12.8% |
| Aortic insufficiency | 28 | 8.5% |
| Dyspneashortness of breath | 16 | 4.9% |
| Stenosis | 16 | 4.9% |
| Endocarditis | 15 | 4.6% |
| Aortic regurgitation | 14 | 4.3% |
| Heart failure | 7 | 2.1% |
| Thrombus | 5 | 1.5% |
| Bacterial infectiona bacterial infection | 4 | 1.2% |
| Failure of implant | 4 | 1.2% |
| Stroke/cva | 4 | 1.2% |
| Abscessa collection of pus | 3 | 0.9% |
| Cardiac arrestthe heart stopped | 3 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Mitroflow Aortic Pericardial Heart Valve | Product code DYE | All MAUDE reports |
|---|---|---|---|
| Reports | 328 | 37,240 | 26,136,888 |
| Share of that pool | — | 0.9% | 0% |
| Classified as death, per 1,000 reports | 168 | 36 | 9 |
| Classified as injury | 59.8% | 92.7% | 36.2% |
| Classified as malfunction | 1.8% | 3.5% | 62.3% |
| Filed by the manufacturer | 97% | 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 Theon Pericardial Bioprosthesis | 1,643 | 46 | 3.9% |
| 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% |
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 Mitroflow Aortic Pericardial Heart Valve reports
How many FDA reports name Mitroflow Aortic Pericardial Heart Valve?
328 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 (59.8%), other (21.6%) and death (16.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (31.4%), calcified (22.3%), gradient increase (11.9%), material deformation (9.8%) and occlusion within device (6.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97%), voluntary reports (2.1%) and distributor reports (0.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Mitroflow Aortic Pericardial 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.