Device manufacturer, as written on reports
Heart Valves Santa Ana: medical device reports filed with FDA
1,018 reports name it as the manufacturer of the device involved, 2011–2022.
- 1,018
- reports naming it as manufacturer
- 0% of all MAUDE reports
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 3.7%
- classified as malfunction
- 62.3% across all reports
- 6.2%
- classified as death, as reported
- 0.9% across all reports
1,018 medical device reports received by FDA give Heart Valves Santa Ana as the manufacturer of the device involved, 0% of the MAUDE database, from October 2011 to December 2022. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
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 (90%), death (6.2%) and malfunction (3.7%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."
Brands named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| Mosaic Aortic Bioprosthetic Heart Valve | Replacement heart-valve | 135 | 405 | 2.8% |
| Freestyle Aortic Root Bioprosthesis | Heart-valve, non-allograft tissue | 79 | 202 | 6% |
| Mosaic Mitral Bioprosthetic Heart Valve | Heart-valve, non-allograft tissue | 67 | 154 | 6.4% |
| Mosaic | Replacement heart-valve | 64 | 131 | 0.5% |
| Evolut R Transcatheter Aortic Valve | Aortic valve, prosthesis, percutaneously delivered | 53 | 521 | 9.6% |
| Melody Transcather Pulmonary | Pulmonary valve prosthesis percutaneously delivered | 53 | 0 | 4% |
| Contegra | Pulmonic valved conduit | 39 | 43 | 2.4% |
| Corevalve Transcatheter Aortic Valve | Aortic valve, prosthesis, percutaneously delivered | 35 | 60 | 9.6% |
| CG Future Band | Ring, annuloplasty | 28 | 131 | 1.1% |
| Evolut Pro Plus Valve | Aortic valve, prosthesis, percutaneously delivered | 26 | 780 | 12.8% |
| Hancock | Heart-valve, non-allograft tissue | 24 | 22 | 1.5% |
| Evolut Pro Transcatheter Aortic Valve | Aortic valve, prosthesis, percutaneously delivered | 23 | 422 | 11% |
| Corevalve 29mm Aortic Valve | Aortic valve, prosthesis, percutaneously delivered | 19 | 0 | 6.4% |
| Accutrak Delivery Catheter System | Aortic valve, prosthesis, percutaneously delivered | 15 | 0 | 8% |
| Corevalve 31mm Aortic Valve | Aortic valve, prosthesis, percutaneously delivered | 15 | 0 | 4.1% |
| Melody Transcatheter Pulmonary Valve | Pulmonary valve prosthesis percutaneously delivered | 12 | 106 | 5.7% |
| Mosaic Porcine Heart Valve | Replacement heart-valve | 11 | 11 | 0.6% |
| Corevalve 26mm Aortic Valve | Aortic valve, prosthesis, percutaneously delivered | 10 | 0 | 7.5% |
| Enveo Pro Delivery System | Aortic valve, prosthesis, percutaneously delivered | 10 | 27 | 9.6% |
| Freestyle | Glucose dehydrogenase, glucose | 10 | 26 | 0.1% |
| Medtronic Transcatheter Valve | Aortic valve, prosthesis, percutaneously delivered | 10 | 262 | 7.2% |
| Corevalve | Aortic valve, prosthesis, percutaneously delivered | 9 | 0 | 9.1% |
| Enveo R Delivery System | Aortic valve, prosthesis, percutaneously delivered | 9 | 6 | 9.9% |
| Evolut Pro Plus Dcs | Aortic valve, prosthesis, percutaneously delivered | 8 | 76 | 13.8% |
| Medtronic Hall Prosthetic Heart Valve | Heart-valve, mechanical | 6 | 0 | 19.8% |
| Corevalve Revalving System | Aortic valve, prosthesis, percutaneously delivered | 5 | 0 | 5.2% |
| Melody Transcather Pulmonary Valve | Pulmonary valve prosthesis percutaneously delivered | 4 | 0 | 5.5% |
| Avalus Aortic Tissue Valve | Heart-valve, non-allograft tissue | 3 | 133 | 11% |
| Confida Brecker Curve Guidewire | Wire, guide, catheter | 2 | 36 | 40.3% |
| Evolut Fx Valve | Aortic valve, prosthesis, percutaneously delivered | 2 | 851 | 14.1% |
Brands with a page on this site, 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."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| LWR | Heart-valve, non-allograft tissue | 495 | 48.6% |
| NPT | Aortic valve, prosthesis, percutaneously delivered | 253 | 24.9% |
| KRH | Ring, annuloplasty | 111 | 10.9% |
| NPV | Pulmonary valve prosthesis percutaneously delivered | 61 | 6% |
| MWH | Pulmonic valved conduit | 55 | 5.4% |
| DYE | Replacement heart-valve | 23 | 2.3% |
| LWQ | Heart-valve, mechanical | 13 | 1.3% |
| DQX | Wire, guide, catheter | 2 | 0.2% |
| GKN | Timer, clot, automated | 2 | 0.2% |
| LDF | Electrode, pacemaker, temporary | 2 | 0.2% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Heart Valves Santa Ana reports
How many FDA device reports name Heart Valves Santa Ana as manufacturer?
1,018 reports through August 2026, 0 of them in the latest 12 months.
Which of its brands appear most often?
Mosaic Aortic Bioprosthetic Heart Valve (135), Freestyle Aortic Root Bioprosthesis (79), Mosaic Mitral Bioprosthetic Heart Valve (67), Mosaic (64) and Evolut R Transcatheter Aortic Valve (53).
Which device types does it report on?
heart-valve, non-allograft tissue (48.6%), aortic valve, prosthesis, percutaneously delivered (24.9%), ring, annuloplasty (10.9%) and pulmonary valve prosthesis percutaneously delivered (6%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."
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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.