Devices › Filter, intravascular, cardiovascular
Device brand name · Vena cava filter
Denali Femoral System: medical device reports filed with FDA
928 reports name it, 2013–2026. Manufacturer given most often on reports: Bard Peripheral Vascular. Product code DTK.
- 928
- device reports naming the brand
- 0% of all MAUDE reports · about 71 a year
- 78
- reports, 12 months to August 2026
- 64 in the 12 months before
- 55.7%
- classified as malfunction
- 29.9% across the product code
- 4.6%
- classified as death, as reported
- 43 reports · not verified by FDA
FDA's MAUDE database holds 928 reports that name the brand "Denali Femoral System" (vena cava filter), received between July 2013 and August 2026; the manufacturer given most often on reports is Bard Peripheral Vascular. Spellings of one product vary from report to report.
78 reports arrived in the 12 months to August 2026, up 22% from 64 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 malfunction (55.7%), injury (39.7%) and death (4.6%); across all filter, intravascular, cardiovascular reports (product code DTK) death is recorded in 2.4% and malfunction in 29.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device or device component (24.4%), malposition of device (22.6%) and difficult to remove (17.3%). The patient problems coded most often are pulmonary embolism, abdominal pain and death. 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 38,361 reports carrying product code DTK. 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 |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 226 | 24.4% | 7.8% |
| Malposition of device | 210 | 22.6% | 10.9% |
| Difficult to removethe device was hard to remove | 161 | 17.3% | 19.8% |
| Patient device interaction problem | 134 | 14.4% | 6.4% |
| Activation failure | 133 | 14.3% | 1.7% |
| Failure to advance | 118 | 12.7% | 1.4% |
| Activation, positioning or separation problem | 104 | 11.2% | 1.1% |
| Patient-device incompatibilitythe device did not suit the patient | 104 | 11.2% | 4.3% |
| Material deformation | 64 | 6.9% | 1.2% |
| Migration or expulsion of device | 60 | 6.5% | 9.6% |
| Positioning problem | 40 | 4.3% | 2% |
| Migrationthe device moved from where it was placed | 36 | 3.9% | 3.1% |
| Deformation due to compressive stress | 26 | 2.8% | 0.2% |
| Positioning failure | 23 | 2.5% | 1.4% |
| Breakthe device broke | 20 | 2.2% | 1% |
| Extrusion | 20 | 2.2% | 1.8% |
| Material twisted/bent | 20 | 2.2% | 0.4% |
| Obstruction of flow | 17 | 1.8% | 4.1% |
| Detachment of device component | 14 | 1.5% | 1.9% |
| Sticking | 12 | 1.3% | 0.9% |
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 |
|---|---|---|
| Pulmonary embolisma blood clot in the lung | 109 | 11.7% |
| Abdominal painstomach or belly pain | 79 | 8.5% |
| Deaththe patient died; cause not stated by this term | 44 | 4.7% |
| Thrombosis/thrombus | 31 | 3.3% |
| Painpain, site not specified | 30 | 3.2% |
| Thrombus | 28 | 3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 22 | 2.4% |
| Foreign body in patientpart of a device left in the patient | 18 | 1.9% |
| Chest painchest pain | 16 | 1.7% |
| Device embedded in tissue or plaque | 15 | 1.6% |
| Great vessel perforation | 10 | 1.1% |
| Injurya physical injury | 8 | 0.9% |
| Hematomaa collection of blood under the skin or in tissue | 7 | 0.8% |
| Thrombosis | 7 | 0.8% |
| Cardiac perforation | 6 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Denali Femoral System | Product code DTK | All MAUDE reports |
|---|---|---|---|
| Reports | 928 | 38,361 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 46 | 24 | 9 |
| Classified as injury | 39.7% | 67% | 36.2% |
| Classified as malfunction | 55.7% | 29.9% | 62.3% |
| Filed by the manufacturer | 100% | 93% | 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 DTK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Gunther Tulip Femoral Vena Cava Filter Set | 1,926 | 0 | 0.6% |
| Gunther Tulip Jugular Vena Cava Filter Set | 1,235 | 0 | 0.7% |
| G2 Filter System - Femoral | 1,122 | 0 | 3.7% |
| 466fxxxx | 936 | 0 | 1.9% |
| Cook Celect Femoral Vena Cava Filter Set | 898 | 0 | 1.3% |
| Unknown Optease Vena Cava Filter | 835 | 0 | 1.7% |
| Greenfield | 735 | 5 | 0.5% |
| Unknown Trapease | 720 | 0 | 1.7% |
| Denali Jugular System | 704 | 45 | 6.3% |
| Option Ivc Filter | 702 | 0 | 2.1% |
| Trapease Pvcf Fem/Jug 55cm Csi | 983 | 0 | 3.7% |
| Optease Retrieval Filter | 685 | 0 | 3.4% |
| Cook Celect Navalign Femoral Vena Cava Filter Set | 673 | 0 | 1.5% |
| Eclipse Filter System - Femoral | 649 | 0 | 6% |
| Recovery Filter System | 613 | 4 | 3.6% |
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 Denali Femoral System reports
How many FDA reports name Denali Femoral System?
928 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 78 in the latest 12 months.
What kinds of events are reported?
malfunction (55.7%), injury (39.7%) and death (4.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (24.4%), malposition of device (22.6%), difficult to remove (17.3%), patient device interaction problem (14.4%) and activation failure (14.3%). 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 Denali Femoral System 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.