Devices › System, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
Device brand name · Vascular covered stent
Covera Vascular Covered Stent: medical device reports filed with FDA
338 reports name it, 2019–2026. Manufacturer given most often on reports: Angiomed & Medizintechnik Kg. Product code PFV.
- 338
- device reports naming the brand
- 0% of all MAUDE reports · about 46 a year
- 42
- reports, 12 months to August 2026
- 65 in the 12 months before
- 57.4%
- classified as malfunction
- 68.3% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 338 reports that name the brand "Covera Vascular Covered Stent" (vascular covered stent), received between March 2019 and August 2026; the manufacturer given most often on reports is Angiomed & Medizintechnik Kg. Spellings of one product vary from report to report.
42 reports arrived in the 12 months to August 2026, down 35% from 65 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 (57.4%), injury (42.3%) and death (0.3%); across all system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment reports (product code PFV) death is recorded in 1.1% and malfunction in 68.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material deformation (21.6%), misfire (17.5%) and break (16.3%). The patient problems coded most often are restenosis, stenosis 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 2,762 reports carrying product code PFV. 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 |
|---|---|---|---|
| Material deformation | 73 | 21.6% | 6.4% |
| Misfire | 59 | 17.5% | 30.3% |
| Breakthe device broke | 55 | 16.3% | 13.5% |
| Positioning failure | 54 | 16% | 31.4% |
| Loss of or failure to bond | 29 | 8.6% | 2.7% |
| Obstruction of flow | 24 | 7.1% | 4.8% |
| Activation failure | 19 | 5.6% | 6.1% |
| Fracturea broken bone | 15 | 4.4% | 20.8% |
| Malposition of device | 13 | 3.8% | 3.2% |
| Detachment of device or device componentpart of the device came off | 9 | 2.7% | 6.8% |
| Difficult to removethe device was hard to remove | 6 | 1.8% | 3.1% |
| Difficult or delayed positioning | 5 | 1.5% | 2.8% |
| Packaging problem | 5 | 1.5% | 0.4% |
| Device contamination with chemical or other material | 4 | 1.2% | 0.1% |
| Device damaged prior to receipt by user | 4 | 1.2% | 0.2% |
| Failure to advance | 3 | 0.9% | 1.3% |
| Migration or expulsion of device | 3 | 0.9% | 1.2% |
| Deformation due to compressive stress | 2 | 0.6% | 0.3% |
| Difficult to advance | 2 | 0.6% | 1.6% |
| Insufficient device problem information | 2 | 0.6% | 1.7% |
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 |
|---|---|---|
| Restenosis | 76 | 22.5% |
| Stenosis | 17 | 5% |
| Thrombosis/thrombus | 17 | 5% |
| Painpain, site not specified | 11 | 3.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 10 | 3% |
| Aneurysm | 9 | 2.7% |
| Obstruction/occlusion | 8 | 2.4% |
| Swelling/ edema | 8 | 2.4% |
| Foreign body in patientpart of a device left in the patient | 5 | 1.5% |
| Ischemia | 5 | 1.5% |
| Hemorrhage/blood loss/bleeding | 4 | 1.2% |
| Bacterial infectiona bacterial infection | 2 | 0.6% |
| Coughcough | 1 | 0.3% |
| Fistula | 1 | 0.3% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Covera Vascular Covered Stent | Product code PFV | All MAUDE reports |
|---|---|---|---|
| Reports | 338 | 2,762 | 26,136,888 |
| Share of that pool | — | 12.2% | 0% |
| Classified as death, per 1,000 reports | 3 | 11 | 9 |
| Classified as injury | 42.3% | 30.6% | 36.2% |
| Classified as malfunction | 57.4% | 68.3% | 62.3% |
| Filed by the manufacturer | 99.7% | 99.4% | 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 PFV
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Fluency Plus Vascular Stent Graft | 736 | 64 | 0.4% |
| Fluency Plus Endovascular Stent Graft | 635 | 35 | 0.6% |
| Gore Viabahn Endoprosthesis - 3 | 354 | 0 | 3.1% |
| GORE VIABAHN Endoprosthesis | 985 | 18 | 5.8% |
| GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface | 906 | 174 | 2.1% |
| Flair Endovascular Stent Graft | 375 | 0 | 0.3% |
| GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface | 341 | 91 | 0.6% |
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 Covera Vascular Covered Stent reports
How many FDA reports name Covera Vascular Covered Stent?
338 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 42 in the latest 12 months.
What kinds of events are reported?
malfunction (57.4%), injury (42.3%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material deformation (21.6%), misfire (17.5%), break (16.3%), positioning failure (16%) and loss of or failure to bond (8.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Covera Vascular Covered Stent 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.