Devices › Stents, drains and dilators for the biliary ducts
Device brand name · Self expanding stents nio
Smart Control Nitinol Stent System: medical device reports filed with FDA
1,438 reports name it, 2002–2016. Manufacturer given most often on reports: Cordis De Mexico. Product code FGE.
- 1,438
- device reports naming the brand
- 0% of all MAUDE reports · about 60 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 48.5%
- classified as malfunction
- 69% across the product code
- 1.7%
- classified as death, as reported
- 24 reports · not verified by FDA
FDA's MAUDE database holds 1,438 reports that name the brand "Smart Control Nitinol Stent System" (self expanding stents nio), received between September 2002 and September 2016; the manufacturer given most often on reports is Cordis De Mexico. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (49.7%), malfunction (48.5%) and death (1.7%); across all stents, drains and dilators for the biliary ducts reports (product code FGE) death is recorded in 1.1% and malfunction in 69%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are premature activation (14.6%), occlusion within device (13.1%) and difficult or delayed positioning (9.9%). The patient problems coded most often are reocclusion, therapy/non-surgical treatment, additional and hospitalization required. 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
No report naming Smart Control Nitinol Stent System was received in the five years to August 2026; the latest was received in September 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 33,832 reports carrying product code FGE. 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 | 210 | 14.6% | 3.9% |
| Occlusion within devicethe device blocked | 189 | 13.1% | 1.9% |
| Difficult or delayed positioning | 143 | 9.9% | 2.7% |
| Inaccurate delivery | 110 | 7.6% | 0.5% |
| Material separation | 102 | 7.1% | 1.5% |
| Fracturea broken bone | 71 | 4.9% | 3.1% |
| Replace | 69 | 4.8% | 2.4% |
| Activation, positioning or separation problem | 68 | 4.7% | 3.1% |
| Device remains implanted | 62 | 4.3% | 2.1% |
| Other (for use when an appropriate device code cannot be identified) | 61 | 4.2% | 1.1% |
| Difficult to removethe device was hard to remove | 51 | 3.5% | 5.8% |
| Inadequacy of device shape and/or size | 46 | 3.2% | 0.4% |
| Material frayed | 42 | 2.9% | 0.2% |
| Torn material | 31 | 2.2% | 0.4% |
| Breakthe device broke | 30 | 2.1% | 9.7% |
| Device, removal of (non-implant) | 30 | 2.1% | 1% |
| Tip breakage | 30 | 2.1% | 0.5% |
| Detachment of device component | 28 | 1.9% | 2.6% |
| Shaft break | 28 | 1.9% | 0.2% |
| Migration or expulsion of device | 26 | 1.8% | 3.3% |
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 | 214 | 14.9% |
| Therapy/non-surgical treatment, additional | 113 | 7.9% |
| Hospitalization required | 48 | 3.3% |
| Thrombosis | 46 | 3.2% |
| Stenosis | 45 | 3.1% |
| Foreign body, removal of | 28 | 1.9% |
| Deaththe patient died; cause not stated by this term | 23 | 1.6% |
| Occlusion | 23 | 1.6% |
| Surgical procedure, additional | 22 | 1.5% |
| Vascular system (circulation), impaired | 22 | 1.5% |
| No patient involvement | 20 | 1.4% |
| Nonresorbable materials, unretrieved in body | 19 | 1.3% |
| Surgical procedure aborted/stopped | 19 | 1.3% |
| Treatment with medication(s) | 17 | 1.2% |
| Other (for use when an appropriate patient code cannot be identified) | 16 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Smart Control Nitinol Stent System | Product code FGE | All MAUDE reports |
|---|---|---|---|
| Reports | 1,438 | 33,832 | 26,136,888 |
| Share of that pool | — | 4.3% | 0% |
| Classified as death, per 1,000 reports | 17 | 11 | 9 |
| Classified as injury | 49.7% | 29% | 36.2% |
| Classified as malfunction | 48.5% | 69% | 62.3% |
| Filed by the manufacturer | 100% | 97.5% | 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 FGE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Mustang | 5,969 | 491 | 0.3% |
| Hurricane RX | 1,227 | 51 | 0.2% |
| Cre Pro | 985 | 341 | 0.1% |
| Advanix Biliary | 872 | 75 | 0.9% |
| WallFlex Biliary RX Stent System | 774 | 25 | 2.2% |
| Absolute Pro .035 Self Expanding Stent System | 858 | 38 | 0.2% |
| Zimmon Biliary Stent | 665 | 45 | 0% |
| Evolution Biliary Controlled-Release Stent - Fully Covered | 600 | 99 | 0.2% |
| WallFlex Biliary | 834 | 56 | 1.8% |
| Zimmon Biliary Stent Set | 530 | 34 | 0% |
| Express LD Vascular | 520 | 47 | 0% |
| Extractor Rx Retrieval Balloon | 499 | 0 | 0.6% |
| Flexima Biliary | 485 | 34 | 0% |
| Zilver 635 Biliary Self Expanding Metal Stent | 362 | 13 | 0% |
| Express Vascular SD | 383 | 28 | 0.8% |
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 Smart Control Nitinol Stent System reports
How many FDA reports name Smart Control Nitinol Stent System?
1,438 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (49.7%), malfunction (48.5%) and death (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
premature activation (14.6%), occlusion within device (13.1%), difficult or delayed positioning (9.9%), inaccurate delivery (7.6%) and material separation (7.1%). 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 Smart Control Nitinol Stent System 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.