Devices › Pancreatic stent, covered, metallic, removable
Device brand name · Pancreatic stent covered metallic removable
AXIOS Stent and Electrocautery Enhanced Delivery System: medical device reports filed with FDA
1,559 reports name it, 2021–2026. Manufacturer given most often on reports: Boston Scientific. Product code PCU.
- 1,559
- device reports naming the brand
- 0% of all MAUDE reports · about 292 a year
- 495
- reports, 12 months to August 2026
- 333 in the 12 months before
- 48.9%
- classified as malfunction
- 44% across the product code
- 3.5%
- classified as death, as reported
- 55 reports · not verified by FDA
1,559 medical device reports received by FDA name the brand "AXIOS Stent and Electrocautery Enhanced Delivery System" (pancreatic stent covered metallic removable); the manufacturer given most often on reports is Boston Scientific; received from March 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
495 reports arrived in the 12 months to August 2026, up 49% from 333 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 (48.9%), injury (47.5%) and death (3.5%); across all pancreatic stent, covered, metallic, removable reports (product code PCU) death is recorded in 3% and malfunction in 44%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are positioning failure (21%), activation, positioning or separation problem (20.7%) and positioning problem (20.5%). The patient problems coded most often are hemorrhage/blood loss/bleeding, perforation and abdominal pain. 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 2,148 reports carrying product code PCU. 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 |
|---|---|---|---|
| Positioning failure | 328 | 21% | 16.1% |
| Activation, positioning or separation problem | 322 | 20.7% | 16.6% |
| Positioning problem | 320 | 20.5% | 21.5% |
| Activation failure | 312 | 20% | 14.9% |
| Migrationthe device moved from where it was placed | 115 | 7.4% | 6.8% |
| Breakthe device broke | 80 | 5.1% | 6.1% |
| Entrapment of device | 69 | 4.4% | 4.2% |
| Electrical /electronic property probleman electrical or electronic problem | 67 | 4.3% | 3.5% |
| Device stenosis | 63 | 4% | 2.5% |
| Difficult or delayed positioning | 60 | 3.8% | 3.9% |
| Detachment of device or device componentpart of the device came off | 59 | 3.8% | 4.5% |
| Premature activation | 54 | 3.5% | 6.5% |
| Difficult to removethe device was hard to remove | 43 | 2.8% | 4.5% |
| Difficult to advance | 41 | 2.6% | 2.3% |
| Material integrity problema problem with the device material | 36 | 2.3% | 2.6% |
| Material deformation | 34 | 2.2% | 2% |
| Failure to conduct | 25 | 1.6% | 1.2% |
| Retraction problem | 23 | 1.5% | 0.6% |
| Difficult or delayed activation | 21 | 1.3% | 0.6% |
| Human-device interface problem | 18 | 1.2% | 1.3% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 125 | 8% |
| Perforation | 77 | 4.9% |
| Abdominal painstomach or belly pain | 38 | 2.4% |
| Biliary leak | 24 | 1.5% |
| Fever | 24 | 1.5% |
| Vomitingbeing sick | 23 | 1.5% |
| Cholangitis | 22 | 1.4% |
| Fistula | 22 | 1.4% |
| Inflammationinflammation | 18 | 1.2% |
| Peritonitis | 16 | 1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 15 | 1% |
| Obstruction/occlusion | 15 | 1% |
| Painpain, site not specified | 13 | 0.8% |
| Sepsisa severe body-wide response to infection | 12 | 0.8% |
| Erosion | 11 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | AXIOS Stent and Electrocautery Enhanced Delivery System | Product code PCU | All MAUDE reports |
|---|---|---|---|
| Reports | 1,559 | 2,148 | 26,136,888 |
| Share of that pool | — | 72.6% | 0% |
| Classified as death, per 1,000 reports | 35 | 30 | 9 |
| Classified as injury | 47.5% | 52.8% | 36.2% |
| Classified as malfunction | 48.9% | 44% | 62.3% |
| Filed by the manufacturer | 100% | 98.4% | 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 PCU
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Axios Stent And Delivery System | 484 | 0 | 4.3% |
| Axios? | 582 | 224 | 1.5% |
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 AXIOS Stent and Electrocautery Enhanced Delivery System reports
How many FDA reports name AXIOS Stent and Electrocautery Enhanced Delivery System?
1,559 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 495 in the latest 12 months.
What kinds of events are reported?
malfunction (48.9%), injury (47.5%) and death (3.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
positioning failure (21%), activation, positioning or separation problem (20.7%), positioning problem (20.5%), activation failure (20%) and migration (7.4%). 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 AXIOS Stent and Electrocautery Enhanced Delivery 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.