Devices › Stent, superficial femoral artery, drug-eluting
Device brand name · Niu stent superficial femoral artery drug-eluting
Zilver Ptx 35 Drug-Eluting Stent: medical device reports filed with FDA
590 reports name it, 2014–2026. Manufacturer given most often on reports: Cook Ireland. Product code NIU.
- 590
- device reports naming the brand
- 0% of all MAUDE reports · about 48 a year
- 16
- reports, 12 months to August 2026
- 42 in the 12 months before
- 37.1%
- classified as malfunction
- 29.4% across the product code
- 0.7%
- classified as death, as reported
- 4 reports · not verified by FDA
590 medical device reports received by FDA name the brand "Zilver Ptx 35 Drug-Eluting Stent" (niu stent superficial femoral artery drug-eluting); the manufacturer given most often on reports is Cook Ireland; received from March 2014 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
16 reports arrived in the 12 months to August 2026, down 62% from 42 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 injury (62.2%), malfunction (37.1%) and death (0.7%); across all stent, superficial femoral artery, drug-eluting reports (product code NIU) death is recorded in 0.6% and malfunction in 29.4%. 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 (14.6%), occlusion within device (12.7%) and fracture (11.7%). The patient problems coded most often are restenosis, reocclusion and stenosis. 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 2,857 reports carrying product code NIU. 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 | 86 | 14.6% | 16.2% |
| Occlusion within devicethe device blocked | 75 | 12.7% | 16.9% |
| Fracturea broken bone | 69 | 11.7% | 11% |
| Improper or incorrect procedure or method | 44 | 7.5% | 2.7% |
| Off-label use | 37 | 6.3% | 1.9% |
| Delivery system failure | 26 | 4.4% | 1.1% |
| Activation failure | 22 | 3.7% | 3% |
| Obstruction of flow | 19 | 3.2% | 1.8% |
| Breakthe device broke | 17 | 2.9% | 1.3% |
| Difficult to removethe device was hard to remove | 16 | 2.7% | 2.4% |
| Structural problem | 16 | 2.7% | 0.8% |
| Material deformation | 11 | 1.9% | 8.4% |
| Deformation due to compressive stress | 8 | 1.4% | 1.5% |
| Insufficient device problem information | 8 | 1.4% | 1.6% |
| Physical resistance/sticking | 7 | 1.2% | 0.2% |
| Device expiration issue | 6 | 1% | 0.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 0.8% | 1.6% |
| Failure to advance | 5 | 0.8% | 1.1% |
| Stretched | 5 | 0.8% | 1.4% |
| Biocompatibility | 3 | 0.5% | 0.1% |
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 | 60 | 10.2% |
| Reocclusion | 49 | 8.3% |
| Stenosis | 39 | 6.6% |
| Occlusion | 38 | 6.4% |
| Obstruction/occlusion | 33 | 5.6% |
| Thrombosis/thrombus | 33 | 5.6% |
| Surgical procedure, additional | 29 | 4.9% |
| Thrombosis | 28 | 4.7% |
| Claudication | 15 | 2.5% |
| Foreign body in patientpart of a device left in the patient | 15 | 2.5% |
| Painpain, site not specified | 13 | 2.2% |
| Amputation | 8 | 1.4% |
| Hemorrhage/blood loss/bleeding | 6 | 1% |
| Ischemia | 6 | 1% |
| Embolism/embolus | 5 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Zilver Ptx 35 Drug-Eluting Stent | Product code NIU | All MAUDE reports |
|---|---|---|---|
| Reports | 590 | 2,857 | 26,136,888 |
| Share of that pool | — | 20.7% | 0% |
| Classified as death, per 1,000 reports | 7 | 6 | 9 |
| Classified as injury | 62.2% | 70% | 36.2% |
| Classified as malfunction | 37.1% | 29.4% | 62.3% |
| Filed by the manufacturer | 90.8% | 96.9% | 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 NIU
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| ELUVIA Drug-Eluting Vascular Stent System | 1,079 | 50 | 0.6% |
| Zilver Ptx Drug-Eluting Peripheral Stent | 727 | 9 | 0% |
| ELUVIATM Drug-Eluting Vascular Stent System | 228 | 32 | 1.8% |
| Cypher Sirolimus-Eluting Coronary Stent | 15,051 | 0 | 10.3% |
| Evolution Biliary Controlled-Release Stent - Uncovered | 194 | 20 | 0% |
| Promus PREMIER | 6,159 | 111 | 6.3% |
| Zenith Fenestrated Graft | 163 | 0 | 20.2% |
| Zilver 635 Biliary Self Expanding Metal Stent | 362 | 13 | 0% |
| Zilver Flex 35 Vascular Self-Expanding Stent | 203 | 23 | 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 Zilver Ptx 35 Drug-Eluting Stent reports
How many FDA reports name Zilver Ptx 35 Drug-Eluting Stent?
590 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 16 in the latest 12 months.
What kinds of events are reported?
injury (62.2%), malfunction (37.1%) 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 (14.6%), occlusion within device (12.7%), fracture (11.7%), improper or incorrect procedure or method (7.5%) and off-label use (6.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (90.8%) and distributor reports (9.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Zilver Ptx 35 Drug-Eluting 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.