Devices › Heart-valve, mechanical
Device brand name · Heart valve
Bjork-Shiley 60 Degree Convexo-Concave: medical device reports filed with FDA
165 reports name it, 1996–2006. Manufacturer given most often on reports: Shiley. Product code LWQ.
- 165
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 5.5%
- classified as malfunction
- 10.3% across the product code
- 27.3%
- classified as death, as reported
- 45 reports · not verified by FDA
FDA's MAUDE database holds 165 reports that name the brand "Bjork-Shiley 60 Degree Convexo-Concave" (heart valve), received between September 1996 and December 2006; the manufacturer given most often on reports is Shiley. Spellings of one product vary from report to report.
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 (67.3%), death (27.3%) and malfunction (5.5%); 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 explanted (53.3%), replace (32.7%) and implant, removal of (30.9%). The patient problems coded most often are death, surgical procedure, repeated and hospitalization required. 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
No report naming Bjork-Shiley 60 Degree Convexo-Concave was received in the five years to August 2026; the latest was received in December 2006.
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 |
|---|---|---|---|
| Explanted | 88 | 53.3% | 24.9% |
| Replace | 54 | 32.7% | 18% |
| Implant, removal of | 51 | 30.9% | 1.9% |
| Strut fracture | 33 | 20% | 0.8% |
| Perivalvular leak | 15 | 9.1% | 4.8% |
| Valve(s), failure of | 14 | 8.5% | 2.6% |
| Device remains implanted | 13 | 7.9% | 2.7% |
| Paravalvular leak(s) | 12 | 7.3% | 4.1% |
| Fracturea broken bone | 11 | 6.7% | 3.6% |
| Migration or expulsion of device | 10 | 6.1% | 0.5% |
| Other (for use when an appropriate device code cannot be identified) | 10 | 6.1% | 2.2% |
| Detachment of device component | 7 | 4.2% | 0.5% |
| Reflux within device | 7 | 4.2% | 0.4% |
| Leak/splashthe device leaked | 6 | 3.6% | 2.1% |
| Component missing | 5 | 3% | 0.2% |
| Disengaged | 5 | 3% | 0.1% |
| Material separation | 5 | 3% | 1.1% |
| Valve(s), defective | 4 | 2.4% | 0.7% |
| Breakthe device broke | 2 | 1.2% | 1.3% |
| Loose | 2 | 1.2% | 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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 39 | 23.6% |
| Surgical procedure, repeated | 37 | 22.4% |
| Hospitalization required | 34 | 20.6% |
| Mitral valve replacement | 34 | 20.6% |
| Leak(s), perivalvular | 26 | 15.8% |
| Therapy/non-surgical treatment, additional | 25 | 15.2% |
| Aortic valve replacement | 24 | 14.5% |
| Other (for use when an appropriate patient code cannot be identified) | 19 | 11.5% |
| Surgical procedure | 13 | 7.9% |
| Mitral regurgitation | 11 | 6.7% |
| Corneal pannus | 10 | 6.1% |
| Thrombosis | 10 | 6.1% |
| Aortic insufficiency | 8 | 4.8% |
| Cardiogenic shockshock from the heart failing to pump | 8 | 4.8% |
| Dyspneashortness of breath | 8 | 4.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bjork-Shiley 60 Degree Convexo-Concave | Product code LWQ | All MAUDE reports |
|---|---|---|---|
| Reports | 165 | 7,097 | 26,136,888 |
| Share of that pool | — | 2.3% | 0% |
| Classified as death, per 1,000 reports | 273 | 127 | 9 |
| Classified as injury | 67.3% | 75.7% | 36.2% |
| Classified as malfunction | 5.5% | 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 |
|---|---|---|---|
| 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% |
| 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% |
| 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 Bjork-Shiley 60 Degree Convexo-Concave reports
How many FDA reports name Bjork-Shiley 60 Degree Convexo-Concave?
165 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (67.3%), death (27.3%) and malfunction (5.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (53.3%), replace (32.7%), implant, removal of (30.9%), strut fracture (20%) and perivalvular leak (9.1%). 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 Bjork-Shiley 60 Degree Convexo-Concave 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.