Devices › Stent, superficial femoral artery
Device brand name · Vascular stent
Lifestent XL Vascular Stent: medical device reports filed with FDA
267 reports name it, 2015–2026. Manufacturer given most often on reports: Angiomed & Medizintechnik Kg. Product code NIP.
- 267
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 20
- reports, 12 months to August 2026
- 61 in the 12 months before
- 49.4%
- classified as malfunction
- 51.3% across the product code
- 0.7%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 267 reports that name the brand "Lifestent XL Vascular Stent" (vascular stent), received between June 2015 and July 2026; the manufacturer given most often on reports is Angiomed & Medizintechnik Kg. Spellings of one product vary from report to report.
20 reports arrived in the 12 months to August 2026, down 67% from 61 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 (49.8%), malfunction (49.4%) 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 fracture (40.1%), material twisted/bent (27.3%) and break (13.1%). The patient problems coded most often are restenosis, stenosis and occlusion. 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 |
|---|---|---|---|
| Fracturea broken bone | 107 | 40.1% | 9.5% |
| Material twisted/bent | 73 | 27.3% | 2.2% |
| Breakthe device broke | 35 | 13.1% | 8.7% |
| Occlusion within devicethe device blocked | 34 | 12.7% | 3.5% |
| Material deformation | 27 | 10.1% | 8% |
| Misfire | 27 | 10.1% | 1.2% |
| Positioning failure | 21 | 7.9% | 6.9% |
| Obstruction of flow | 18 | 6.7% | 1.6% |
| Difficult to removethe device was hard to remove | 17 | 6.4% | 7.8% |
| Material torqued | 12 | 4.5% | 0.6% |
| Difficult or delayed positioning | 9 | 3.4% | 3.6% |
| Activation failure | 8 | 3% | 12.1% |
| Detachment of device or device componentpart of the device came off | 8 | 3% | 4.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 7 | 2.6% | 1.3% |
| Failure to advance | 7 | 2.6% | 2.9% |
| Insufficient device problem information | 3 | 1.1% | 1.6% |
| Loss of or failure to bond | 3 | 1.1% | 0.4% |
| Malposition of device | 3 | 1.1% | 1.6% |
| Dent in material | 2 | 0.7% | 0% |
| Difficult to advance | 2 | 0.7% | 2.5% |
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 |
|---|---|---|
| Restenosis | 28 | 10.5% |
| Stenosis | 26 | 9.7% |
| Occlusion | 22 | 8.2% |
| Reocclusion | 22 | 8.2% |
| Painpain, site not specified | 18 | 6.7% |
| Thrombosis/thrombus | 17 | 6.4% |
| Vascular system (circulation), impaired | 14 | 5.2% |
| Obstruction/occlusion | 12 | 4.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 11 | 4.1% |
| Thrombus | 6 | 2.2% |
| Ischemia | 5 | 1.9% |
| Claudication | 3 | 1.1% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.7% |
| Thrombosis | 2 | 0.7% |
| Arteriosclerosis/ atherosclerosis | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lifestent XL Vascular Stent | Product code NIP | All MAUDE reports |
|---|---|---|---|
| Reports | 267 | 10,627 | 26,136,888 |
| Share of that pool | — | 2.5% | 0% |
| Classified as death, per 1,000 reports | 7 | 18 | 9 |
| Classified as injury | 49.8% | 46.8% | 36.2% |
| Classified as malfunction | 49.4% | 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% |
| 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% |
| 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 Lifestent XL Vascular Stent reports
How many FDA reports name Lifestent XL Vascular Stent?
267 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 20 in the latest 12 months.
What kinds of events are reported?
injury (49.8%), malfunction (49.4%) and death (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (40.1%), material twisted/bent (27.3%), break (13.1%), occlusion within device (12.7%) and material deformation (10.1%). 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 Lifestent XL Vascular 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.