Devices › Heart-valve, mechanical
Device brand name · Heart-valve mechanical
Open Pivot Mechanical Heart Valve: medical device reports filed with FDA
222 reports name it, 2010–2026. Manufacturer given most often on reports: Medtronic. Product code LWQ.
- 222
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 12
- reports, 12 months to August 2026
- 19 in the 12 months before
- 6.3%
- classified as malfunction
- 10.3% across the product code
- 5%
- classified as death, as reported
- 11 reports · not verified by FDA
222 medical device reports received by FDA name the brand "Open Pivot Mechanical Heart Valve" (heart-valve mechanical); the manufacturer given most often on reports is Medtronic; received from November 2010 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
12 reports arrived in the 12 months to August 2026, down 37% from 19 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 (88.7%), malfunction (6.3%) and death (5%); across all heart-valve, mechanical reports (product code LWQ) death is recorded in 12.7% and malfunction in 10.3%. 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 (26.1%), incomplete coaptation (10.4%) and patient device interaction problem (7.7%). The patient problems coded most often are non specific ekg/ECG changes, stroke/cva and mitral valve stenosis. 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 7,097 reports carrying product code LWQ. 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 | 58 | 26.1% | 14.4% |
| Incomplete coaptation | 23 | 10.4% | 5.2% |
| Patient device interaction problem | 17 | 7.7% | 2.8% |
| Detachment of device or device componentpart of the device came off | 8 | 3.6% | 1.6% |
| Mechanical jam | 8 | 3.6% | 0.8% |
| Inadequacy of device shape and/or size | 6 | 2.7% | 2.7% |
| Perivalvular leak | 6 | 2.7% | 4.8% |
| Breakthe device broke | 4 | 1.8% | 1.3% |
| Device stenosis | 3 | 1.4% | 0.8% |
| Gradient increase | 3 | 1.4% | 2.3% |
| Structural problem | 3 | 1.4% | 0.2% |
| Detachment of device component | 2 | 0.9% | 0.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.9% | 1.5% |
| Difficult to open or close | 2 | 0.9% | 1.1% |
| Fracturea broken bone | 2 | 0.9% | 3.6% |
| Improper or incorrect procedure or method | 2 | 0.9% | 0.6% |
| Intravalvular regurgitation | 2 | 0.9% | 0.7% |
| Material fragmentation | 2 | 0.9% | 0.2% |
| Biocompatibility | 1 | 0.5% | 1.1% |
| Defective devicethe device was defective | 1 | 0.5% | 0.1% |
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 |
|---|---|---|
| Non specific ekg/ECG changes | 9 | 4.1% |
| Stroke/cva | 7 | 3.2% |
| Mitral valve stenosis | 6 | 2.7% |
| Atrial fibrillationan irregular heart rhythm | 5 | 2.3% |
| Corneal pannus | 5 | 2.3% |
| Deaththe patient died; cause not stated by this term | 5 | 2.3% |
| Thrombosis/thrombus | 5 | 2.3% |
| Hemorrhage/blood loss/bleeding | 4 | 1.8% |
| Thrombus | 4 | 1.8% |
| Heart block | 3 | 1.4% |
| Low blood pressure/ hypotension | 3 | 1.4% |
| Mitral regurgitation | 3 | 1.4% |
| Pericardial effusionfluid around the heart | 3 | 1.4% |
| Bradycardiaslow heart rate | 2 | 0.9% |
| Complete heart block | 2 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Open Pivot Mechanical Heart Valve | Product code LWQ | All MAUDE reports |
|---|---|---|---|
| Reports | 222 | 7,097 | 26,136,888 |
| Share of that pool | — | 3.1% | 0% |
| Classified as death, per 1,000 reports | 50 | 127 | 9 |
| Classified as injury | 88.7% | 75.7% | 36.2% |
| Classified as malfunction | 6.3% | 10.3% | 62.3% |
| Filed by the manufacturer | 99.1% | 92.6% | 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 LWQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Aortic Ap | 409 | 44 | 2.7% |
| Standard Cuff | 329 | 0 | 10.6% |
| Regent Heart Valve with Flex Cuff | 268 | 65 | 5.2% |
| Sjm Masters Series Mechanical Heart Valve | 259 | 0 | 12.4% |
| Sjm Regent Heart Valve W/Flex Cuff | 246 | 0 | 13% |
| Medtronic Hall Prosthetic Heart Valve | 207 | 0 | 19.8% |
| Sjm Mechanical Heart Valve | 178 | 0 | 7.9% |
| Bjork-Shiley 60 Degree Convexo-Concave | 165 | 0 | 27.3% |
| Trifecta | 227 | 115 | 8.8% |
| Mosaic Aortic Bioprosthetic Heart Valve | 3,406 | 405 | 2.8% |
| Trifecta Stented Tissue Valve | 290 | 0 | 7.9% |
| Carpentier-Edwards Perimount Pericardial Bioprosthesis | 978 | 1 | 10% |
| Shiley | 12,236 | 1,513 | 1.1% |
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 Open Pivot Mechanical Heart Valve reports
How many FDA reports name Open Pivot Mechanical Heart Valve?
222 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 12 in the latest 12 months.
What kinds of events are reported?
injury (88.7%), malfunction (6.3%) and death (5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (26.1%), incomplete coaptation (10.4%), patient device interaction problem (7.7%), detachment of device or device component (3.6%) and mechanical jam (3.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Open Pivot Mechanical 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.