Devices › Stent, superficial femoral artery
Device brand name · Stent superficial femoral artery
Innova? Vascular: medical device reports filed with FDA
203 reports name it, 2018–2026. Manufacturer given most often on reports: Boston Scientific. Product code NIP.
- 203
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 15
- reports, 12 months to August 2026
- 15 in the 12 months before
- 76.8%
- classified as malfunction
- 51.3% across the product code
- 2%
- classified as death, as reported
- 4 reports · not verified by FDA
203 medical device reports received by FDA name the brand "Innova? Vascular" (stent superficial femoral artery); the manufacturer given most often on reports is Boston Scientific; received from January 2018 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
15 reports arrived in the 12 months to August 2026, close to the 15 of 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 (76.8%), injury (21.2%) and death (2%); 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 premature activation (43.3%), activation, positioning or separation problem (15.8%) and material deformation (13.8%). The patient problems coded most often are foreign body in patient, no patient involvement 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 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 |
|---|---|---|---|
| Premature activation | 88 | 43.3% | 5% |
| Activation, positioning or separation problem | 32 | 15.8% | 7.7% |
| Material deformation | 28 | 13.8% | 8% |
| Entrapment of device | 24 | 11.8% | 2.1% |
| Fracturea broken bone | 17 | 8.4% | 9.5% |
| Failure to advance | 16 | 7.9% | 2.9% |
| Difficult to removethe device was hard to remove | 15 | 7.4% | 7.8% |
| Difficult to advance | 13 | 6.4% | 2.5% |
| Positioning problem | 11 | 5.4% | 1% |
| Defective devicethe device was defective | 7 | 3.4% | 0.8% |
| Material integrity problema problem with the device material | 7 | 3.4% | 0.1% |
| Device-device incompatibility | 5 | 2.5% | 0.3% |
| Difficult to insertthe device was hard to insert | 5 | 2.5% | 0.4% |
| Activation failure | 4 | 2% | 12.1% |
| Breakthe device broke | 4 | 2% | 8.7% |
| Deformation due to compressive stress | 3 | 1.5% | 0.7% |
| Detachment of device or device componentpart of the device came off | 3 | 1.5% | 4.1% |
| Device dislodged or dislocated | 3 | 1.5% | 0.9% |
| Difficult or delayed positioning | 3 | 1.5% | 3.6% |
| Activation problem | 2 | 1% | 0.5% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 6 | 3% |
| No patient involvement | 6 | 3% |
| Deaththe patient died; cause not stated by this term | 4 | 2% |
| Device embedded in tissue or plaque | 2 | 1% |
| Obstruction/occlusion | 2 | 1% |
| Perforation of vessels | 2 | 1% |
| Device overstimulation of tissue | 1 | 0.5% |
| Discomfortdiscomfort | 1 | 0.5% |
| Painpain, site not specified | 1 | 0.5% |
| Reocclusion | 1 | 0.5% |
| Restenosis | 1 | 0.5% |
| Thrombosis | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Innova? Vascular | Product code NIP | All MAUDE reports |
|---|---|---|---|
| Reports | 203 | 10,627 | 26,136,888 |
| Share of that pool | — | 1.9% | 0% |
| Classified as death, per 1,000 reports | 20 | 18 | 9 |
| Classified as injury | 21.2% | 46.8% | 36.2% |
| Classified as malfunction | 76.8% | 51.3% | 62.3% |
| Filed by the manufacturer | 98% | 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% |
| GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface | 906 | 174 | 2.1% |
| 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% |
| 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 Innova? Vascular reports
How many FDA reports name Innova? Vascular?
203 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 15 in the latest 12 months.
What kinds of events are reported?
malfunction (76.8%), injury (21.2%) and death (2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
premature activation (43.3%), activation, positioning or separation problem (15.8%), material deformation (13.8%), entrapment of device (11.8%) and fracture (8.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Innova? Vascular 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.