Devices › Stent, superficial femoral artery
Device brand name · Stent superficial femoral artery
Innova: medical device reports filed with FDA
868 reports name it, 2005–2026. Manufacturer given most often on reports: Boston Scientific - Maple Grove. Product code NIP.
- 868
- device reports naming the brand
- 0% of all MAUDE reports · about 41 a year
- 32
- reports, 12 months to August 2026
- 33 in the 12 months before
- 53.1%
- classified as malfunction
- 51.3% across the product code
- 0.7%
- classified as death, as reported
- 6 reports · not verified by FDA
868 medical device reports received by FDA name the brand "Innova" (stent superficial femoral artery); the manufacturer given most often on reports is Boston Scientific - Maple Grove; received from July 2005 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
32 reports arrived in the 12 months to August 2026, close to the 33 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 (53.1%), injury (46.2%) and death (0.7%); 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, positioning or separation problem (35.5%), premature activation (14.3%) and fracture (11.2%). The patient problems coded most often are reocclusion, device embedded in tissue or plaque and no patient involvement. 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, positioning or separation problem | 308 | 35.5% | 7.7% |
| Premature activation | 124 | 14.3% | 5% |
| Fracturea broken bone | 97 | 11.2% | 9.5% |
| Bent | 95 | 10.9% | 1% |
| Entrapment of device | 80 | 9.2% | 2.1% |
| Stretched | 74 | 8.5% | 4% |
| Difficult to removethe device was hard to remove | 49 | 5.6% | 7.8% |
| Occlusion within devicethe device blocked | 49 | 5.6% | 3.5% |
| Material deformation | 29 | 3.3% | 8% |
| Breakthe device broke | 25 | 2.9% | 8.7% |
| Activation failure | 20 | 2.3% | 12.1% |
| Positioning failure | 15 | 1.7% | 6.9% |
| Positioning problem | 14 | 1.6% | 1% |
| Difficult or delayed positioning | 13 | 1.5% | 3.6% |
| Difficult to advance | 13 | 1.5% | 2.5% |
| Detachment of device component | 11 | 1.3% | 3.8% |
| Failure to advance | 8 | 0.9% | 2.9% |
| Malposition of device | 8 | 0.9% | 1.6% |
| Detachment of device or device componentpart of the device came off | 7 | 0.8% | 4.1% |
| Defective devicethe device was defective | 6 | 0.7% | 0.8% |
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 |
|---|---|---|
| Reocclusion | 69 | 7.9% |
| Device embedded in tissue or plaque | 26 | 3% |
| No patient involvement | 25 | 2.9% |
| Restenosis | 19 | 2.2% |
| Painpain, site not specified | 17 | 2% |
| Obstruction/occlusion | 13 | 1.5% |
| Thrombosis | 12 | 1.4% |
| Thrombosis/thrombus | 12 | 1.4% |
| Claudication | 11 | 1.3% |
| Occlusion | 8 | 0.9% |
| Perforation of vessels | 7 | 0.8% |
| Arteriosclerosis/ atherosclerosis | 6 | 0.7% |
| Deaththe patient died; cause not stated by this term | 6 | 0.7% |
| Discomfortdiscomfort | 3 | 0.3% |
| Hemorrhage/blood loss/bleeding | 3 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Innova | Product code NIP | All MAUDE reports |
|---|---|---|---|
| Reports | 868 | 10,627 | 26,136,888 |
| Share of that pool | — | 8.2% | 0% |
| Classified as death, per 1,000 reports | 7 | 18 | 9 |
| Classified as injury | 46.2% | 46.8% | 36.2% |
| Classified as malfunction | 53.1% | 51.3% | 62.3% |
| Filed by the manufacturer | 96% | 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% |
| 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 Innova reports
How many FDA reports name Innova?
868 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 32 in the latest 12 months.
What kinds of events are reported?
malfunction (53.1%), injury (46.2%) and death (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation, positioning or separation problem (35.5%), premature activation (14.3%), fracture (11.2%), bent (10.9%) and entrapment of device (9.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Innova 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.