Devices › Transcatheter septal occluder
Device brand name · Mlv / occluder transcatheter septal
Gore Helex Septal Occluder: medical device reports filed with FDA
279 reports name it, 2007–2024. Manufacturer given most often on reports: W L Gore & Associates. Product code MLV.
- 279
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 5.4%
- classified as malfunction
- 37.8% across the product code
- 0.4%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 279 reports that name the brand "Gore Helex Septal Occluder" (mlv / occluder transcatheter septal), received between January 2007 and August 2024; the manufacturer given most often on reports is W L Gore & Associates. 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 (94.3%), malfunction (5.4%) and death (0.4%); across all transcatheter septal occluder reports (product code MLV) death is recorded in 2.8% and malfunction in 37.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration or expulsion of device (27.6%), insufficient device problem information (10%) and explanted (7.5%). The patient problems coded most often are embolism, surgical procedure and therapy/non-surgical treatment, additional. 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 6,948 reports carrying product code MLV. 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 |
|---|---|---|---|
| Migration or expulsion of device | 77 | 27.6% | 14.5% |
| Insufficient device problem information | 28 | 10% | 3.8% |
| Explanted | 21 | 7.5% | 4% |
| Device dislodged or dislocated | 20 | 7.2% | 2.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 20 | 7.2% | 1.5% |
| Malposition of device | 17 | 6.1% | 1.1% |
| Fracturea broken bone | 15 | 5.4% | 0.5% |
| Replace | 15 | 5.4% | 1.3% |
| Device, removal of (non-implant) | 14 | 5% | 1.5% |
| Difficult to removethe device was hard to remove | 13 | 4.7% | 1.6% |
| Detachment of device component | 12 | 4.3% | 0.9% |
| Device remains implanted | 12 | 4.3% | 1.2% |
| Breakthe device broke | 10 | 3.6% | 0.6% |
| Difficult to position | 8 | 2.9% | 0.7% |
| Entrapment of device | 6 | 2.2% | 0.4% |
| Leak/splashthe device leaked | 6 | 2.2% | 0.5% |
| Defective devicethe device was defective | 4 | 1.4% | 0.2% |
| Improper or incorrect procedure or method | 4 | 1.4% | 1.4% |
| Inadequacy of device shape and/or size | 4 | 1.4% | 2.3% |
| Occlusion within devicethe device blocked | 4 | 1.4% | 0.4% |
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 |
|---|---|---|
| Embolism | 48 | 17.2% |
| Surgical procedure | 18 | 6.5% |
| Therapy/non-surgical treatment, additional | 18 | 6.5% |
| Hospitalization required | 13 | 4.7% |
| Thrombus | 12 | 4.3% |
| Surgical procedure, additional | 11 | 3.9% |
| Atrial fibrillationan irregular heart rhythm | 10 | 3.6% |
| Treatment with medication(s) | 9 | 3.2% |
| Cardiac tamponade | 8 | 2.9% |
| Embolus | 8 | 2.9% |
| Improved patient condition | 8 | 2.9% |
| Stroke/cva | 7 | 2.5% |
| Surgical procedure, repeated | 7 | 2.5% |
| Arrhythmia | 6 | 2.2% |
| Complete heart block | 6 | 2.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Gore Helex Septal Occluder | Product code MLV | All MAUDE reports |
|---|---|---|---|
| Reports | 279 | 6,948 | 26,136,888 |
| Share of that pool | — | 4% | 0% |
| Classified as death, per 1,000 reports | 4 | 28 | 9 |
| Classified as injury | 94.3% | 58.1% | 36.2% |
| Classified as malfunction | 5.4% | 37.8% | 62.3% |
| Filed by the manufacturer | 98.9% | 97.4% | 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 MLV
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Amplatzer Septal Occluder | 3,495 | 406 | 2.4% |
| Amplatzer PFO Occluder | 598 | 42 | 2.8% |
| GORE CARDIOFORM Septal Occluder | 535 | 80 | 1.3% |
| Amplatzer Talisman PFO Occluder | 426 | 125 | 0.9% |
| Amplatzer Cribriform Occluder | 279 | 0 | 0.4% |
| GORE CARDIOFORM ASD Occluder | 274 | 57 | 0.7% |
| Amplatzer Multi-Fenestrated Septal Occluder - Cribriform | 255 | 63 | 0.4% |
| Amplatzer Muscular VSD Occluder | 242 | 44 | 9.1% |
| Amplatzer Duct Occluder | 513 | 83 | 2.1% |
| Amplatzer Torqvue Delivery System | 208 | 29 | 7.2% |
| GORE DrySeal Flex Introducer Sheath | 1,177 | 283 | 5.3% |
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 Gore Helex Septal Occluder reports
How many FDA reports name Gore Helex Septal Occluder?
279 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 (94.3%), malfunction (5.4%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration or expulsion of device (27.6%), insufficient device problem information (10%), explanted (7.5%), device dislodged or dislocated (7.2%) and device operates differently than expected (7.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.9%) and voluntary reports (0.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Gore Helex Septal Occluder 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.