Devices › Heart-valve, non-allograft tissue
Device brand name · Tissue heart valve
Perceval Sutureless Aortic Heart Valve: medical device reports filed with FDA
1,473 reports name it, 2016–2026. Manufacturer given most often on reports: Livanova Canada. Product code LWR.
- 1,473
- device reports naming the brand
- 0% of all MAUDE reports · about 142 a year
- 18
- reports, 12 months to August 2026
- 33 in the 12 months before
- 2.3%
- classified as malfunction
- 4.9% across the product code
- 9.1%
- classified as death, as reported
- 134 reports · not verified by FDA
1,473 medical device reports received by FDA name the brand "Perceval Sutureless Aortic Heart Valve" (tissue heart valve); the manufacturer given most often on reports is Livanova Canada; received from February 2016 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
18 reports arrived in the 12 months to August 2026, down 45% from 33 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 (88.3%), death (9.1%) and malfunction (2.3%); 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 (27.4%), perivalvular leak (18.3%) and patient-device incompatibility (12.4%). The patient problems coded most often are aortic insufficiency, aortic valve stenosis and aortic valve insufficiency/ 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 | 404 | 27.4% | 25.2% |
| Perivalvular leak | 270 | 18.3% | 6% |
| Patient-device incompatibilitythe device did not suit the patient | 183 | 12.4% | 2.5% |
| Degraded | 135 | 9.2% | 3.7% |
| Inadequacy of device shape and/or size | 117 | 7.9% | 2.2% |
| Incomplete coaptation | 67 | 4.5% | 3.1% |
| Leak/splashthe device leaked | 66 | 4.5% | 2.1% |
| Calcified | 55 | 3.7% | 5.7% |
| Device dislodged or dislocated | 55 | 3.7% | 0.4% |
| Collapse | 54 | 3.7% | 0.3% |
| Gradient increase | 50 | 3.4% | 6.1% |
| Malposition of device | 46 | 3.1% | 0.5% |
| Difficult to fold, unfold or collapse | 33 | 2.2% | 0.1% |
| Material too rigid or stiff | 28 | 1.9% | 0.4% |
| Material deformation | 27 | 1.8% | 0.9% |
| Migrationthe device moved from where it was placed | 26 | 1.8% | 0.2% |
| Positioning failure | 21 | 1.4% | 0.1% |
| Difficult to open or close | 18 | 1.2% | 0.5% |
| Detachment of device or device componentpart of the device came off | 15 | 1% | 0.4% |
| Off-label use | 14 | 1% | 0.3% |
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 insufficiency | 185 | 12.6% |
| Aortic valve stenosis | 163 | 11.1% |
| Aortic valve insufficiency/ regurgitation | 158 | 10.7% |
| Complete heart block | 157 | 10.7% |
| Aortic regurgitation | 138 | 9.4% |
| Endocarditis | 97 | 6.6% |
| Deaththe patient died; cause not stated by this term | 80 | 5.4% |
| Dyspneashortness of breath | 44 | 3% |
| Heart failure/congestive heart failure | 30 | 2% |
| Hemorrhage/blood loss/bleeding | 29 | 2% |
| Thrombocytopenialow platelets | 27 | 1.8% |
| Abscessa collection of pus | 24 | 1.6% |
| Calcium deposits/calcification | 22 | 1.5% |
| Arrhythmia | 21 | 1.4% |
| Heart block | 17 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Perceval Sutureless Aortic Heart Valve | Product code LWR | All MAUDE reports |
|---|---|---|---|
| Reports | 1,473 | 25,638 | 26,136,888 |
| Share of that pool | — | 5.7% | 0% |
| Classified as death, per 1,000 reports | 91 | 80 | 9 |
| Classified as injury | 88.3% | 86.2% | 36.2% |
| Classified as malfunction | 2.3% | 4.9% | 62.3% |
| Filed by the manufacturer | 72.4% | 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 |
|---|---|---|---|
| Freestyle Aortic Root Bioprosthesis | 2,344 | 202 | 6% |
| Edwards INSPIRIS RESILIA Aortic Valve | 2,035 | 599 | 0.8% |
| Sjm Trifecta Valve | 1,525 | 0 | 8.1% |
| 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 Perceval Sutureless Aortic Heart Valve reports
How many FDA reports name Perceval Sutureless Aortic Heart Valve?
1,473 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 18 in the latest 12 months.
What kinds of events are reported?
injury (88.3%), death (9.1%) and malfunction (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (27.4%), perivalvular leak (18.3%), patient-device incompatibility (12.4%), degraded (9.2%) and inadequacy of device shape and/or size (7.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (72.4%) and distributor reports (27.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Perceval Sutureless Aortic 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.