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Device brand name · Endovascular suturing system
Endo Anchor System - Heli-Fx Aaa: medical device reports filed with FDA
1,063 reports name it, 2015–2026. Manufacturer given most often on reports: Medtronic Ireland. Product code OTD.
- 1,063
- device reports naming the brand
- 0% of all MAUDE reports · about 97 a year
- 50
- reports, 12 months to August 2026
- 68 in the 12 months before
- 37.4%
- classified as malfunction
- 36.5% across the product code
- 10.4%
- classified as death, as reported
- 111 reports · not verified by FDA
FDA's MAUDE database holds 1,063 reports that name the brand "Endo Anchor System - Heli-Fx Aaa" (endovascular suturing system), received between July 2015 and August 2026; the manufacturer given most often on reports is Medtronic Ireland. Spellings of one product vary from report to report.
50 reports arrived in the 12 months to August 2026, down 26% from 68 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 (52.1%), malfunction (37.4%) and death (10.4%); across all endovascular suturing system reports (product code OTD) death is recorded in 10.6% and malfunction in 36.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are leak/splash (42.3%), device dislodged or dislocated (7.3%) and fracture (6.9%). The patient problems coded most often are injury, death and device embedded in tissue or plaque. 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 1,189 reports carrying product code OTD. 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 450 | 42.3% | 40.8% |
| Device dislodged or dislocated | 78 | 7.3% | 7.7% |
| Fracturea broken bone | 73 | 6.9% | 6.7% |
| Breakthe device broke | 47 | 4.4% | 4.5% |
| Activation, positioning or separation problem | 43 | 4% | 3.8% |
| Malposition of device | 39 | 3.7% | 4.2% |
| Device damaged by another device | 31 | 2.9% | 2.8% |
| Device difficult to setup or prepare | 31 | 2.9% | 2.9% |
| Material deformation | 16 | 1.5% | 1.5% |
| Misfire | 15 | 1.4% | 1.3% |
| Device contamination with chemical or other material | 14 | 1.3% | 1.2% |
| Component missing | 13 | 1.2% | 1.3% |
| Device displays incorrect message | 13 | 1.2% | 1.1% |
| Migration or expulsion of device | 12 | 1.1% | 1.3% |
| Difficult to insertthe device was hard to insert | 9 | 0.8% | 1.2% |
| Insufficient device problem information | 9 | 0.8% | 1.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 8 | 0.8% | 0.8% |
| Positioning problem | 6 | 0.6% | 0.7% |
| Difficult to removethe device was hard to remove | 5 | 0.5% | 0.8% |
| Defective devicethe device was defective | 3 | 0.3% | 0.3% |
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 |
|---|---|---|
| Injurya physical injury | 222 | 20.9% |
| Deaththe patient died; cause not stated by this term | 81 | 7.6% |
| Device embedded in tissue or plaque | 50 | 4.7% |
| Painpain, site not specified | 49 | 4.6% |
| Rupturethe device burst | 41 | 3.9% |
| Blood loss | 40 | 3.8% |
| Renal failurekidney failure | 29 | 2.7% |
| Ischemia | 27 | 2.5% |
| Anemialow red blood cells | 26 | 2.4% |
| Hemorrhage/blood loss/bleeding | 24 | 2.3% |
| Aneurysm | 23 | 2.2% |
| Fever | 23 | 2.2% |
| Low blood pressure/ hypotension | 21 | 2% |
| Obstruction/occlusion | 18 | 1.7% |
| Vascular dissection | 14 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endo Anchor System - Heli-Fx Aaa | Product code OTD | All MAUDE reports |
|---|---|---|---|
| Reports | 1,063 | 1,189 | 26,136,888 |
| Share of that pool | — | 89.4% | 0% |
| Classified as death, per 1,000 reports | 104 | 106 | 9 |
| Classified as injury | 52.1% | 52.5% | 36.2% |
| Classified as malfunction | 37.4% | 36.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.2% | 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."
Questions about Endo Anchor System - Heli-Fx Aaa reports
How many FDA reports name Endo Anchor System - Heli-Fx Aaa?
1,063 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 50 in the latest 12 months.
What kinds of events are reported?
injury (52.1%), malfunction (37.4%) and death (10.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (42.3%), device dislodged or dislocated (7.3%), fracture (6.9%), break (4.4%) and activation, positioning or separation problem (4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Endo Anchor System - Heli-Fx Aaa 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.