Devices › Stent, superficial femoral artery
Device brand name · Stent superficial femoral artery
GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface: medical device reports filed with FDA
906 reports name it, 2009–2026. Manufacturer given most often on reports: W L Gore & Associates. Product code NIP.
- 906
- device reports naming the brand
- 0% of all MAUDE reports · about 53 a year
- 174
- reports, 12 months to August 2026
- 210 in the 12 months before
- 50%
- classified as malfunction
- 51.3% across the product code
- 2.1%
- classified as death, as reported
- 19 reports · not verified by FDA
FDA's MAUDE database holds 906 reports that name the brand "GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface" (stent superficial femoral artery), received between May 2009 and August 2026; the manufacturer given most often on reports is W L Gore & Associates. Spellings of one product vary from report to report.
174 reports arrived in the 12 months to August 2026, down 17% from 210 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 (50%), injury (47.9%) and death (2.1%); across all stent, superficial femoral artery reports (product code NIP) death is recorded in 1.8% and malfunction in 51.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are activation failure (35.9%), complete blockage (5.5%) and detachment of device or device component (5.4%). The patient problems coded most often are obstruction/occlusion, thrombosis/thrombus and clinical endoleak. 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 10,627 reports carrying product code NIP. 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 |
|---|---|---|---|
| Activation failure | 325 | 35.9% | 12.1% |
| Complete blockage | 50 | 5.5% | 0.8% |
| Detachment of device or device componentpart of the device came off | 49 | 5.4% | 4.1% |
| Breakthe device broke | 41 | 4.5% | 8.7% |
| Material separation | 41 | 4.5% | 6.3% |
| Migrationthe device moved from where it was placed | 40 | 4.4% | 1.3% |
| Patient-device incompatibilitythe device did not suit the patient | 40 | 4.4% | 0.9% |
| Physical resistance/sticking | 35 | 3.9% | 1.9% |
| Obstruction of flow | 34 | 3.8% | 1.6% |
| Device stenosis | 31 | 3.4% | 0.7% |
| Insufficient device problem information | 24 | 2.6% | 1.6% |
| Separation failure | 18 | 2% | 0.3% |
| Partial blockage | 15 | 1.7% | 0.5% |
| Loss of or failure to bond | 14 | 1.5% | 0.4% |
| Material fragmentation | 14 | 1.5% | 0.3% |
| Activation problem | 13 | 1.4% | 0.5% |
| Device endoleak | 12 | 1.3% | 0.3% |
| Malposition of device | 12 | 1.3% | 1.6% |
| Premature activation | 11 | 1.2% | 5% |
| Difficult or delayed activation | 10 | 1.1% | 2.9% |
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 |
|---|---|---|
| Obstruction/occlusion | 128 | 14.1% |
| Thrombosis/thrombus | 62 | 6.8% |
| Clinical endoleak | 33 | 3.6% |
| Stenosis | 32 | 3.5% |
| Pseudoaneurysm | 22 | 2.4% |
| Foreign body in patientpart of a device left in the patient | 18 | 2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 16 | 1.8% |
| Occlusion | 12 | 1.3% |
| Perforation of vessels | 12 | 1.3% |
| Hemorrhage/blood loss/bleeding | 11 | 1.2% |
| Stroke/cva | 10 | 1.1% |
| Vascular dissection | 9 | 1% |
| Aneurysm | 8 | 0.9% |
| Failure of implant | 8 | 0.9% |
| Ischemia stroke | 8 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface | Product code NIP | All MAUDE reports |
|---|---|---|---|
| Reports | 906 | 10,627 | 26,136,888 |
| Share of that pool | — | 8.5% | 0% |
| Classified as death, per 1,000 reports | 21 | 18 | 9 |
| Classified as injury | 47.9% | 46.8% | 36.2% |
| Classified as malfunction | 50% | 51.3% | 62.3% |
| Filed by the manufacturer | 100% | 97.8% | 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 NIP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Supera Self-Expanding Stent System | 1,726 | 0 | 0.9% |
| Innova | 868 | 32 | 0.7% |
| GORE VIABAHN Endoprosthesis | 985 | 18 | 5.8% |
| BioMimics 3D Vascular Stent System | 581 | 10 | 0% |
| Supera | 517 | 159 | 4.6% |
| Lifestent Solo Vascular Stent System | 396 | 0 | 0% |
| Everflex Self-Expanding Peripheral Stent With Entrust Delivery System Long | 385 | 26 | 0.5% |
| LifeStent Vascular Stent | 341 | 7 | 2.9% |
| LifeStent 5F Vascular Stent | 333 | 54 | 0.6% |
| GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface | 341 | 91 | 0.6% |
| Lifestent XL Vascular Stent | 267 | 20 | 0.7% |
| Supera Peripheral Stent System | 236 | 3 | 3.4% |
| Innova? Vascular | 203 | 15 | 2% |
| Everflex Self-Expanding Peripheral Stent With Entrust Delivery System Standard | 197 | 16 | 2% |
| Lifestent Vascular Stent System | 201 | 0 | 0.5% |
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 GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface reports
How many FDA reports name GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface?
906 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 174 in the latest 12 months.
What kinds of events are reported?
malfunction (50%), injury (47.9%) and death (2.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation failure (35.9%), complete blockage (5.5%), detachment of device or device component (5.4%), break (4.5%) and material separation (4.5%). 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 GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface 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.