Devices › Heart-valve, allograft
Device brand name · Heart valve allograft
Cryovalve: medical device reports filed with FDA
316 reports name it, 1996–2008. Manufacturer given most often on reports: Cryolife. Product code MIE.
- 316
- device reports naming the brand
- 0% of all MAUDE reports · about 11 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 4.1%
- classified as malfunction
- 6.3% across the product code
- 5.4%
- classified as death, as reported
- 17 reports · not verified by FDA
316 medical device reports received by FDA name the brand "Cryovalve" (heart valve allograft); the manufacturer given most often on reports is Cryolife; received from November 1996 to September 2008. 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 (81.3%), other (8.9%) and death (5.4%); across all heart-valve, allograft reports (product code MIE) death is recorded in 7.6% and malfunction in 6.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are explanted (64.9%), replace (31%) and calcified (12%). The patient problems coded most often are surgical procedure, repeated, pulmonary valve replacement and aortic valve replacement. 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
No report naming Cryovalve was received in the five years to August 2026; the latest was received in September 2008.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 474 reports carrying product code MIE. 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 |
|---|---|---|---|
| Explanted | 205 | 64.9% | 45.6% |
| Replace | 98 | 31% | 27% |
| Calcified | 38 | 12% | 8.9% |
| Device remains implanted | 33 | 10.4% | 10.1% |
| Tears, rips, holes in device, device material | 29 | 9.2% | 9.1% |
| Valve(s), failure of | 20 | 6.3% | 4.2% |
| Degraded | 17 | 5.4% | 4% |
| Obstruction of flow | 17 | 5.4% | 4.9% |
| Inadequacy of device shape and/or size | 14 | 4.4% | 4.4% |
| Implant, removal of | 8 | 2.5% | 1.3% |
| Leaflet disruption, cause unknown | 7 | 2.2% | 1.5% |
| Leak/splashthe device leaked | 7 | 2.2% | 2.3% |
| Other (for use when an appropriate device code cannot be identified) | 7 | 2.2% | 2.3% |
| Repair | 6 | 1.9% | 1.9% |
| Restricted flow rate | 6 | 1.9% | 1.3% |
| Device issuea problem with the device | 5 | 1.6% | 0.8% |
| Surgical graft, failure of | 4 | 1.3% | 0.2% |
| Suture line disruption | 4 | 1.3% | 0.4% |
| Valve(s), defective | 4 | 1.3% | 0.8% |
| Contamination | 3 | 0.9% | 1.9% |
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 |
|---|---|---|
| Surgical procedure, repeated | 64 | 20.3% |
| Pulmonary valve replacement | 51 | 16.1% |
| Aortic valve replacement | 48 | 15.2% |
| Hospitalization required | 46 | 14.6% |
| Aortic insufficiency | 37 | 11.7% |
| Surgical procedure | 37 | 11.7% |
| Pulmonary valve stenosis | 34 | 10.8% |
| Calcium deposits/calcification | 30 | 9.5% |
| Stenosis | 30 | 9.5% |
| Other (for use when an appropriate patient code cannot be identified) | 28 | 8.9% |
| Aortic regurgitation | 24 | 7.6% |
| Therapy/non-surgical treatment, additional | 23 | 7.3% |
| Endocarditis | 19 | 6% |
| Pulmonary insufficiency | 18 | 5.7% |
| Aortic valve stenosis | 17 | 5.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cryovalve | Product code MIE | All MAUDE reports |
|---|---|---|---|
| Reports | 316 | 474 | 26,136,888 |
| Share of that pool | — | 66.7% | 0% |
| Classified as death, per 1,000 reports | 54 | 76 | 9 |
| Classified as injury | 81.3% | 72.8% | 36.2% |
| Classified as malfunction | 4.1% | 6.3% | 62.3% |
| Filed by the manufacturer | 100% | 91.1% | 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."
Questions about Cryovalve reports
How many FDA reports name Cryovalve?
316 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 (81.3%), other (8.9%) and death (5.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (64.9%), replace (31%), calcified (12%), device remains implanted (10.4%) and tears, rips, holes in device, device material (9.2%). 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 Cryovalve 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.