Devices › Agent, occluding, vascular, permanent
Device brand name · Agent occluding vascular permanent
Vena Seal Closure System: medical device reports filed with FDA
1,141 reports name it, 2016–2026. Manufacturer given most often on reports: Medtronic Ireland. Product code PJQ.
- 1,141
- device reports naming the brand
- 0% of all MAUDE reports · about 110 a year
- 91
- reports, 12 months to August 2026
- 70 in the 12 months before
- 5.3%
- classified as malfunction
- 5.9% across the product code
- 1.3%
- classified as death, as reported
- 15 reports · not verified by FDA
FDA's MAUDE database holds 1,141 reports that name the brand "Vena Seal Closure System" (agent occluding vascular permanent), received between March 2016 and August 2026; the manufacturer given most often on reports is Medtronic Ireland. Spellings of one product vary from report to report.
91 reports arrived in the 12 months to August 2026, up 30% from 70 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 (93.4%), malfunction (5.3%) and death (1.3%); across all agent, occluding, vascular, permanent reports (product code PJQ) death is recorded in 1.4% and malfunction in 5.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are biocompatibility (38.6%), patient-device incompatibility (5.8%) and detachment of device or device component (1.7%). The patient problems coded most often are hypersensitivity/allergic reaction, pain and thrombosis/thrombus. 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 1,328 reports carrying product code PJQ. 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 |
|---|---|---|---|
| Biocompatibility | 440 | 38.6% | 39.4% |
| Patient-device incompatibilitythe device did not suit the patient | 66 | 5.8% | 5.6% |
| Detachment of device or device componentpart of the device came off | 19 | 1.7% | 2% |
| Migration or expulsion of device | 16 | 1.4% | 1.4% |
| Activation, positioning or separation problem | 11 | 1% | 0.9% |
| Defective devicethe device was defective | 11 | 1% | 0.8% |
| Difficult to removethe device was hard to remove | 7 | 0.6% | 0.9% |
| Obstruction of flow | 7 | 0.6% | 0.7% |
| Compatibility problem | 5 | 0.4% | 0.4% |
| Material deformation | 5 | 0.4% | 0.6% |
| Delivered as unsterile product | 4 | 0.4% | 0.5% |
| Device difficult to setup or prepare | 4 | 0.4% | 0.3% |
| Deformation due to compressive stress | 3 | 0.3% | 0.2% |
| Nonstandard device | 3 | 0.3% | 0.2% |
| Complete blockage | 2 | 0.2% | 0.2% |
| Device damaged prior to receipt by user | 2 | 0.2% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.2% | 0.2% |
| Difficult to advance | 2 | 0.2% | 0.3% |
| Difficult to insertthe device was hard to insert | 2 | 0.2% | 0.2% |
| Improper or incorrect procedure or method | 2 | 0.2% | 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 |
|---|---|---|
| Hypersensitivity/allergic reaction | 297 | 26% |
| Painpain, site not specified | 200 | 17.5% |
| Thrombosis/thrombus | 149 | 13.1% |
| Vasculitisinflammation of blood vessels | 127 | 11.1% |
| Local reaction | 118 | 10.3% |
| Rashskin rash | 117 | 10.3% |
| Swelling/ edema | 106 | 9.3% |
| Itching sensation | 102 | 8.9% |
| Inflammationinflammation | 99 | 8.7% |
| Reactiona reaction, type not specified | 87 | 7.6% |
| Thrombus | 66 | 5.8% |
| Granuloma | 57 | 5% |
| Skin inflammation/ irritation | 49 | 4.3% |
| Erythemaskin redness | 48 | 4.2% |
| Foreign body reaction | 45 | 3.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Vena Seal Closure System | Product code PJQ | All MAUDE reports |
|---|---|---|---|
| Reports | 1,141 | 1,328 | 26,136,888 |
| Share of that pool | — | 85.9% | 0% |
| Classified as death, per 1,000 reports | 13 | 14 | 9 |
| Classified as injury | 93.4% | 92.7% | 36.2% |
| Classified as malfunction | 5.3% | 5.9% | 62.3% |
| Filed by the manufacturer | 100% | 98% | 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."
Questions about Vena Seal Closure System reports
How many FDA reports name Vena Seal Closure System?
1,141 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 91 in the latest 12 months.
What kinds of events are reported?
injury (93.4%), malfunction (5.3%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
biocompatibility (38.6%), patient-device incompatibility (5.8%), detachment of device or device component (1.7%), migration or expulsion of device (1.4%) and activation, positioning or separation problem (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 Vena Seal Closure 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.