Devices › Device types
FDA product code NIP · class 3 · Unknown
Stent, superficial femoral artery: medical device reports filed with FDA
10,627 reports carry this product code, 2003–2026; 30 brands with a page.
- 10,627
- reports with this product code
- 0% of all MAUDE reports
- 719
- reports, 12 months to August 2026
- 985 in the 12 months before
- 51.3%
- classified as malfunction
- 62.3% across all reports
- 1.8%
- classified as death, as reported
- 0.9% across all reports
Product code NIP is FDA's classification for "Stent, superficial femoral artery" (unknown panel), a class 3 device. 10,627 medical device reports carry this product code, 0% of the MAUDE database, from June 2003 to August 2026.
719 reports arrived in the 12 months to August 2026, down 27% from 985 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 (51.3%), injury (46.8%) and death (1.8%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Angiomed & Medizintechnik Kg | 1,996 | 18.8% |
| W L Gore & Associates | 1,992 | 18.7% |
| Abbott Vascular | 1,783 | 16.8% |
| Av-Temecula-Ct | 1,188 | 11.2% |
| Boston Scientific - Maple Grove | 514 | 4.8% |
| Biotronik Buelach Switzerland | 366 | 3.4% |
| Covidien | 314 | 3% |
| Terumo Ashitaka | 118 | 1.1% |
| Biotronik | 94 | 0.9% |
| Medtronic Ireland | 69 | 0.6% |
| Cordis De Mexico | 41 | 0.4% |
| Cordis | 38 | 0.4% |
| Ev3 | 28 | 0.3% |
| Terumo Medical | 23 | 0.2% |
| Cordis US | 20 | 0.2% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Activation failure | 1,288 | 12.1% |
| Fracturea broken bone | 1,009 | 9.5% |
| Breakthe device broke | 922 | 8.7% |
| Material deformation | 847 | 8% |
| Difficult to removethe device was hard to remove | 831 | 7.8% |
| Activation, positioning or separation problem | 816 | 7.7% |
| Positioning failure | 736 | 6.9% |
| Material separation | 667 | 6.3% |
| Premature activation | 534 | 5% |
| Detachment of device or device componentpart of the device came off | 438 | 4.1% |
| Stretched | 424 | 4% |
| Improper or incorrect procedure or method | 417 | 3.9% |
| Detachment of device component | 409 | 3.8% |
| Difficult or delayed positioning | 380 | 3.6% |
| Occlusion within devicethe device blocked | 370 | 3.5% |
| Failure to advance | 312 | 2.9% |
| Difficult or delayed activation | 308 | 2.9% |
| Difficult to advance | 265 | 2.5% |
| Material twisted/bent | 236 | 2.2% |
| Mechanical jam | 231 | 2.2% |
Questions about stent, superficial femoral artery reports
What is product code NIP?
FDA's classification code for "Stent, superficial femoral artery", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
10,627 reports through August 2026, 719 of them in the latest 12 months.
Which brands appear most often?
Supera Self-Expanding Stent System (1,718), GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface (801), Innova (782), GORE VIABAHN Endoprosthesis (766) and BioMimics 3D Vascular Stent System (581). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.