Devices › Dilator, vessel, for percutaneous catheterization
Device brand name · Cardiology vascular access dre
Si Avanti Plus: medical device reports filed with FDA
253 reports name it, 2002–2016. Manufacturer given most often on reports: Cordis De Mexico. Product code DRE.
- 253
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 66.4%
- classified as malfunction
- 40.9% across the product code
- 0.8%
- classified as death, as reported
- 2 reports · not verified by FDA
253 medical device reports received by FDA name the brand "Si Avanti Plus" (cardiology vascular access dre); the manufacturer given most often on reports is Cordis De Mexico; received from April 2002 to September 2016. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 malfunction (66.4%), injury (32.4%) and death (0.8%); across all dilator, vessel, for percutaneous catheterization reports (product code DRE) death is recorded in 5.8% and malfunction in 40.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are obstruction of flow (31.2%), material separation (10.3%) and packaging problem (7.9%). The patient problems coded most often are device embedded in tissue or plaque, hematoma and pseudoaneurysm. 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 Si Avanti Plus 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 3,180 reports carrying product code DRE. 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 |
|---|---|---|---|
| Obstruction of flow | 79 | 31.2% | 2.5% |
| Material separation | 26 | 10.3% | 8.8% |
| Packaging problem | 20 | 7.9% | 1.8% |
| Device contamination with chemical or other material | 18 | 7.1% | 2.7% |
| Detachment of device component | 17 | 6.7% | 3.3% |
| Breakthe device broke | 12 | 4.7% | 6.5% |
| Fracturea broken bone | 11 | 4.3% | 8.1% |
| Stretched | 7 | 2.8% | 0.5% |
| Difficult to removethe device was hard to remove | 6 | 2.4% | 5.1% |
| Foreign material | 6 | 2.4% | 0.3% |
| Other (for use when an appropriate device code cannot be identified) | 6 | 2.4% | 0.9% |
| Occlusion within devicethe device blocked | 4 | 1.6% | 0.1% |
| Unraveled material | 4 | 1.6% | 1.2% |
| Difficult to flush | 3 | 1.2% | 0.1% |
| No pressure | 3 | 1.2% | 0.1% |
| Out-of-box failure | 3 | 1.2% | 0.1% |
| Device contaminated during manufacture or shipping | 2 | 0.8% | 0.2% |
| Device, removal of (non-implant) | 2 | 0.8% | 0.3% |
| Sterility | 2 | 0.8% | 0.1% |
| Component falling | 1 | 0.4% | 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 |
|---|---|---|
| Device embedded in tissue or plaque | 11 | 4.3% |
| Hematomaa collection of blood under the skin or in tissue | 11 | 4.3% |
| Pseudoaneurysm | 10 | 4% |
| Hemorrhage/blood loss/bleeding | 7 | 2.8% |
| Therapy/non-surgical treatment, additional | 7 | 2.8% |
| Surgical procedure, additional | 4 | 1.6% |
| Foreign body, removal of | 3 | 1.2% |
| Injurya physical injury | 3 | 1.2% |
| No patient involvement | 3 | 1.2% |
| Occlusion | 3 | 1.2% |
| Other (for use when an appropriate patient code cannot be identified) | 3 | 1.2% |
| Surgical procedure | 3 | 1.2% |
| Allergic reactionan allergic reaction | 2 | 0.8% |
| Bleeding | 2 | 0.8% |
| Chillschills or shivering | 2 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Si Avanti Plus | Product code DRE | All MAUDE reports |
|---|---|---|---|
| Reports | 253 | 3,180 | 26,136,888 |
| Share of that pool | — | 8% | 0% |
| Classified as death, per 1,000 reports | 8 | 58 | 9 |
| Classified as injury | 32.4% | 52.7% | 36.2% |
| Classified as malfunction | 66.4% | 40.9% | 62.3% |
| Filed by the manufacturer | 100% | 93.6% | 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 DRE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| VersaCross Connect LAAC Access Solution | 1,111 | 371 | 6% |
| VersaCross Connect Access Solution for FARADRIVE | 569 | 280 | 1.9% |
| Spectranetics Tightrail Rotating Dilator Sheath | 171 | 0 | 21.1% |
| Micropuncture Transitionless Stiffened Cannula Access Set | 404 | 19 | 0% |
| Micropuncture Transitionless Access Set | 380 | 19 | 0.3% |
| Super Sheath Introducer Sheath | 169 | 1 | 0% |
| AngioDynamics | 174 | 14 | 1.7% |
| VersaCross Access Solution | 418 | 144 | 7.9% |
| Merit Custom Kit | 1,590 | 13 | 0.1% |
| Evolution Biliary Controlled-Release Stent - Fully Covered | 600 | 99 | 0.2% |
| Peritoneal Dialysis Catheter | 264 | 55 | 2.3% |
| Arrow | 830 | 65 | 3.4% |
| Edwards Sapien Transcatheter Heart Valve | 1,947 | 7 | 14.3% |
| Edwards SAPIEN XT Transcatheter Heart Valve | 2,249 | 48 | 7.6% |
| Flexor Raabe Guiding Sheath | 539 | 30 | 1.1% |
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 Si Avanti Plus reports
How many FDA reports name Si Avanti Plus?
253 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?
malfunction (66.4%), injury (32.4%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
obstruction of flow (31.2%), material separation (10.3%), packaging problem (7.9%), device contamination with chemical or other material (7.1%) and detachment of device component (6.7%). 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 Si Avanti Plus 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.