Devices › Heart-valve, mechanical
Device brand name · Heart-valve mechanical
Aortic Ap: medical device reports filed with FDA
409 reports name it, 2010–2026. Manufacturer given most often on reports: Medtronic. Product code LWQ.
- 409
- device reports naming the brand
- 0% of all MAUDE reports · about 26 a year
- 44
- reports, 12 months to August 2026
- 40 in the 12 months before
- 5.6%
- classified as malfunction
- 10.3% across the product code
- 2.7%
- classified as death, as reported
- 11 reports · not verified by FDA
FDA's MAUDE database holds 409 reports that name the brand "Aortic Ap" (heart-valve mechanical), received between November 2010 and July 2026; the manufacturer given most often on reports is Medtronic. Spellings of one product vary from report to report.
44 reports arrived in the 12 months to August 2026, up 10% from 40 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 (91.7%), malfunction (5.6%) and death (2.7%); 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 (27.6%), inadequacy of device shape and/or size (18.3%) and incomplete coaptation (14.7%). The patient problems coded most often are obstruction/occlusion, non specific ekg/ECG changes and heart block. 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 | 113 | 27.6% | 14.4% |
| Inadequacy of device shape and/or size | 75 | 18.3% | 2.7% |
| Incomplete coaptation | 60 | 14.7% | 5.2% |
| Patient device interaction problem | 38 | 9.3% | 2.8% |
| Mechanical jam | 15 | 3.7% | 0.8% |
| Perivalvular leak | 15 | 3.7% | 4.8% |
| Detachment of device or device componentpart of the device came off | 14 | 3.4% | 1.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 14 | 3.4% | 1.5% |
| Gradient increase | 11 | 2.7% | 2.3% |
| Fracturea broken bone | 10 | 2.4% | 3.6% |
| Intravalvular regurgitation | 10 | 2.4% | 0.7% |
| Patient-device incompatibilitythe device did not suit the patient | 8 | 2% | 1.2% |
| Difficult to open or close | 5 | 1.2% | 1.1% |
| Material separation | 4 | 1% | 1.1% |
| Device stenosis | 3 | 0.7% | 0.8% |
| Material split, cut or torn | 3 | 0.7% | 0.3% |
| Entrapment of device | 2 | 0.5% | 0.4% |
| Improper or incorrect procedure or method | 2 | 0.5% | 0.6% |
| Leak/splashthe device leaked | 2 | 0.5% | 2.1% |
| Material fragmentation | 2 | 0.5% | 0.2% |
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 |
|---|---|---|
| Obstruction/occlusion | 15 | 3.7% |
| Non specific ekg/ECG changes | 13 | 3.2% |
| Heart block | 12 | 2.9% |
| Aortic valve stenosis | 9 | 2.2% |
| Deaththe patient died; cause not stated by this term | 9 | 2.2% |
| Occlusion | 9 | 2.2% |
| Aortic valve insufficiency/ regurgitation | 8 | 2% |
| Endocarditis | 8 | 2% |
| Aortic regurgitation | 7 | 1.7% |
| Calcium deposits/calcification | 6 | 1.5% |
| Valvular insufficiency/ regurgitation | 5 | 1.2% |
| Aortic insufficiency | 4 | 1% |
| Cardiac arrestthe heart stopped | 4 | 1% |
| Atrial fibrillationan irregular heart rhythm | 3 | 0.7% |
| Atrial flutter | 3 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Aortic Ap | Product code LWQ | All MAUDE reports |
|---|---|---|---|
| Reports | 409 | 7,097 | 26,136,888 |
| Share of that pool | — | 5.8% | 0% |
| Classified as death, per 1,000 reports | 27 | 127 | 9 |
| Classified as injury | 91.7% | 75.7% | 36.2% |
| Classified as malfunction | 5.6% | 10.3% | 62.3% |
| Filed by the manufacturer | 100% | 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 |
|---|---|---|---|
| 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% |
| Open Pivot Mechanical Heart Valve | 222 | 12 | 5% |
| 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 Aortic Ap reports
How many FDA reports name Aortic Ap?
409 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 44 in the latest 12 months.
What kinds of events are reported?
injury (91.7%), malfunction (5.6%) and death (2.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (27.6%), inadequacy of device shape and/or size (18.3%), incomplete coaptation (14.7%), patient device interaction problem (9.3%) and mechanical jam (3.7%). 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 Aortic Ap 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.