Devices › Stents, drains and dilators for the biliary ducts
Device brand name · Fge catheter biliary diagnostic - biliary stent - metal
Zilver 635 Biliary Self Expanding Metal Stent: medical device reports filed with FDA
362 reports name it, 2014–2026. Manufacturer given most often on reports: Cook Ireland. Product code FGE.
- 362
- device reports naming the brand
- 0% of all MAUDE reports · about 29 a year
- 13
- reports, 12 months to August 2026
- 32 in the 12 months before
- 71.8%
- classified as malfunction
- 69% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
362 medical device reports received by FDA name the brand "Zilver 635 Biliary Self Expanding Metal Stent" (fge catheter biliary diagnostic - biliary stent - metal); the manufacturer given most often on reports is Cook Ireland; received from February 2014 to June 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
13 reports arrived in the 12 months to August 2026, down 59% from 32 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 (71.8%) and injury (28.2%); 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 improper or incorrect procedure or method (21.5%), activation, positioning or separation problem (17.1%) and off-label use (15.2%). The patient problems coded most often are obstruction/occlusion, inflammation and abscess. 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 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 |
|---|---|---|---|
| Improper or incorrect procedure or method | 78 | 21.5% | 4% |
| Activation, positioning or separation problem | 62 | 17.1% | 3.1% |
| Off-label use | 55 | 15.2% | 1.9% |
| Breakthe device broke | 50 | 13.8% | 9.7% |
| Premature activation | 29 | 8% | 3.9% |
| Activation failure | 22 | 6.1% | 1.3% |
| Fracturea broken bone | 21 | 5.8% | 3.1% |
| Delivery system failure | 15 | 4.1% | 0.2% |
| Material deformation | 13 | 3.6% | 3.9% |
| Material twisted/bent | 8 | 2.2% | 1.1% |
| Dent in material | 7 | 1.9% | 1% |
| Material separation | 7 | 1.9% | 1.5% |
| Migrationthe device moved from where it was placed | 6 | 1.7% | 1.5% |
| Partial blockage | 6 | 1.7% | 0.6% |
| Detachment of device or device componentpart of the device came off | 5 | 1.4% | 3.3% |
| Failure to advance | 5 | 1.4% | 2.2% |
| Material integrity problema problem with the device material | 4 | 1.1% | 0.6% |
| Device damaged prior to usethe device was damaged before use | 3 | 0.8% | 1% |
| Mechanical problema mechanical problem | 3 | 0.8% | 0% |
| Activation problem | 2 | 0.6% | 0% |
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 |
|---|---|---|
| Obstruction/occlusion | 29 | 8% |
| Inflammationinflammation | 20 | 5.5% |
| Abscessa collection of pus | 12 | 3.3% |
| Occlusion | 10 | 2.8% |
| Cholangitis | 9 | 2.5% |
| Foreign body in patientpart of a device left in the patient | 6 | 1.7% |
| Jaundiceyellowing of the skin or eyes | 6 | 1.7% |
| Hemorrhage/blood loss/bleeding | 5 | 1.4% |
| Pancreatitisinflammation of the pancreas | 5 | 1.4% |
| Unintended radiation exposure | 4 | 1.1% |
| Abdominal painstomach or belly pain | 3 | 0.8% |
| Itching sensation | 3 | 0.8% |
| Sepsisa severe body-wide response to infection | 3 | 0.8% |
| Device embedded in tissue or plaque | 2 | 0.6% |
| Perforation | 2 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Zilver 635 Biliary Self Expanding Metal Stent | Product code FGE | All MAUDE reports |
|---|---|---|---|
| Reports | 362 | 33,832 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 11 | 9 |
| Classified as injury | 28.2% | 29% | 36.2% |
| Classified as malfunction | 71.8% | 69% | 62.3% |
| Filed by the manufacturer | 96.1% | 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% |
| Smart Control Nitinol Stent System | 1,438 | 0 | 1.7% |
| 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% |
| 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 Zilver 635 Biliary Self Expanding Metal Stent reports
How many FDA reports name Zilver 635 Biliary Self Expanding Metal Stent?
362 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 13 in the latest 12 months.
What kinds of events are reported?
malfunction (71.8%) and injury (28.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
improper or incorrect procedure or method (21.5%), activation, positioning or separation problem (17.1%), off-label use (15.2%), break (13.8%) and premature activation (8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96.1%) and distributor reports (3.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Zilver 635 Biliary Self Expanding Metal 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.