Devices › Heart-valve, non-allograft tissue
Device brand name · Heart-valve non-allograft tissue
Freestyle Aortic Root Bioprosthesis: medical device reports filed with FDA
2,344 reports name it, 1996–2026. Manufacturer given most often on reports: Medtronic Heart Valves Division. Product code LWR.
- 2,344
- device reports naming the brand
- 0% of all MAUDE reports · about 79 a year
- 202
- reports, 12 months to August 2026
- 237 in the 12 months before
- 4.2%
- classified as malfunction
- 4.9% across the product code
- 6%
- classified as death, as reported
- 141 reports · not verified by FDA
FDA's MAUDE database holds 2,344 reports that name the brand "Freestyle Aortic Root Bioprosthesis" (heart-valve non-allograft tissue), received between October 1996 and August 2026; the manufacturer given most often on reports is Medtronic Heart Valves Division. Spellings of one product vary from report to report.
202 reports arrived in the 12 months to August 2026, down 15% from 237 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 (89.8%), death (6%) and malfunction (4.2%); across all heart-valve, non-allograft tissue reports (product code LWR) death is recorded in 8% and malfunction in 4.9%. 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 (50.9%), intravalvular regurgitation (13.4%) and patient device interaction problem (8.5%). The patient problems coded most often are aortic valve insufficiency/ regurgitation, aortic valve stenosis and aortic regurgitation. 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 25,638 reports carrying product code LWR. 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 | 1,192 | 50.9% | 25.2% |
| Intravalvular regurgitation | 315 | 13.4% | 4.4% |
| Patient device interaction problem | 199 | 8.5% | 3.5% |
| Gradient increase | 134 | 5.7% | 6.1% |
| Calcified | 110 | 4.7% | 5.7% |
| Device stenosis | 99 | 4.2% | 4.1% |
| Explanted | 79 | 3.4% | 12.8% |
| Material split, cut or torn | 79 | 3.4% | 3.6% |
| Replace | 65 | 2.8% | 5.1% |
| Perivalvular leak | 61 | 2.6% | 6% |
| Other (for use when an appropriate device code cannot be identified) | 52 | 2.2% | 1.6% |
| Degraded | 45 | 1.9% | 3.7% |
| Device remains implanted | 43 | 1.8% | 0.7% |
| Incomplete coaptation | 35 | 1.5% | 3.1% |
| Structural problem | 34 | 1.5% | 0.7% |
| Inadequacy of device shape and/or size | 30 | 1.3% | 2.2% |
| Material separation | 22 | 0.9% | 0.4% |
| Tears, rips, holes in device, device material | 22 | 0.9% | 1.7% |
| Material deformation | 19 | 0.8% | 0.9% |
| Torn material | 19 | 0.8% | 1.3% |
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 insufficiency/ regurgitation | 575 | 24.5% |
| Aortic valve stenosis | 375 | 16% |
| Aortic regurgitation | 227 | 9.7% |
| Aortic insufficiency | 216 | 9.2% |
| Calcium deposits/calcification | 138 | 5.9% |
| Endocarditis | 133 | 5.7% |
| Deaththe patient died; cause not stated by this term | 98 | 4.2% |
| Non specific ekg/ECG changes | 93 | 4% |
| Pseudoaneurysm | 80 | 3.4% |
| Cusp tear | 75 | 3.2% |
| Stroke/cva | 74 | 3.2% |
| Dyspneashortness of breath | 61 | 2.6% |
| Heart block | 59 | 2.5% |
| Atrial fibrillationan irregular heart rhythm | 54 | 2.3% |
| Hemorrhage/blood loss/bleeding | 51 | 2.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Freestyle Aortic Root Bioprosthesis | Product code LWR | All MAUDE reports |
|---|---|---|---|
| Reports | 2,344 | 25,638 | 26,136,888 |
| Share of that pool | — | 9.1% | 0% |
| Classified as death, per 1,000 reports | 60 | 80 | 9 |
| Classified as injury | 89.8% | 86.2% | 36.2% |
| Classified as malfunction | 4.2% | 4.9% | 62.3% |
| Filed by the manufacturer | 99.9% | 95.7% | 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 LWR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Edwards INSPIRIS RESILIA Aortic Valve | 2,035 | 599 | 0.8% |
| Sjm Trifecta Valve | 1,525 | 0 | 8.1% |
| Perceval Sutureless Aortic Heart Valve | 1,473 | 18 | 9.1% |
| Mosaic Aortic Bioprosthetic Heart Valve | 3,406 | 405 | 2.8% |
| Carpentier-Edwards Perimount Pericardial Bioprosthesis | 978 | 1 | 10% |
| Carpentier-Edwards Bioprosthesis | 1,055 | 3 | 5% |
| Mosaic Mitral Bioprosthetic Heart Valve | 1,534 | 154 | 6.4% |
| Carpentier-Edwards PERIMOUNT Plus Pericardial Bioprosthesis | 2,878 | 18 | 8.7% |
| Carpentier-Edwards Perimount Magna Aortic Bioprosthesis | 1,324 | 11 | 27.1% |
| Carpentier-Edwards Perimount Rsr Pericardial Bioprosthesis | 3,288 | 13 | 3.3% |
| Trifecta GT Valve | 674 | 66 | 9.5% |
| EDWARDS INTUITY ELITE Valve System | 677 | 62 | 2.2% |
| Avalus Aortic Tissue Valve | 652 | 133 | 11% |
| INSPIRIS RESILIA Aortic Valve | 532 | 87 | 0.4% |
| Epic Stented Porcine Heart Valve W/Flexfit System | 450 | 0 | 7.1% |
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 Freestyle Aortic Root Bioprosthesis reports
How many FDA reports name Freestyle Aortic Root Bioprosthesis?
2,344 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 202 in the latest 12 months.
What kinds of events are reported?
injury (89.8%), death (6%) and malfunction (4.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (50.9%), intravalvular regurgitation (13.4%), patient device interaction problem (8.5%), gradient increase (5.7%) and calcified (4.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Freestyle Aortic Root 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.