Stent LEV4027-PMARecalls & reported problems
Microvention, Inc. · LVIS EVO · Class 3 · Implant
All models of Stent (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429117897), received between Dec 10, 2024 and Dec 10, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Activation Failure” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2024Activation Failure; Activation Failure
AS REPORTED: THE MD WAS PERFORMING A STENT/COIL OF AN ICA TERMINUS ANEURYSM USING AND LVIS 4 MM X 27 MM STENT. THE STENT WAS PREPPED ACCORDING TO IFU INSTRUCTION AND OBSERVED DISTAL OPENING. A HEADWAY 17 WAS PREPPED AND INSERTED INTO A SOFIA 6F-125CM CATHETER, ZOOM TRACKSTAR WAS USED AS A GUIDE. THE HEADWAY 17 WAS TRACKED OVER A SYNCHRO SOFT GUIDEWIRE TO THE DISTAL PORTION OF THE PCOMM VESSEL 2.54 MM IN DIAMETER, NO ACA WAS PRESENT. THE STENT WAS THEN LOADED INTO THE HEADWAY 17 AND ADVANCED WITHOUT ISSUE TO THE DISTAL PCOMM. AN SL10 WAS ALSO INSERTED INTO THE SOFIA 6F-125 CM AND ADVANCED OVER A SYNCHRO SOFT GUIDEWIRE AND INSERTED INTO THE MID REGION OF THE ANEURYSM TO BE JAILED INTO POSITION. THE MD PROCEEDED TO UNSHEATH THE STENT AND OPENING OF THE DISTAL STENT WAS OBSERVED AND CONTINUED ACROSS THE NECK OF THE ANEURYSM AND INTO THE ICA, MEASURING 3.79 MM. UNSHEATHING OF THE STENT INTO THE ICA WAS OBSERVED WITH INITIAL OPENING OF THE STENT IN STRAIGHT SEGMENT, THEN STARTING TO RIBBON AROUND THE PROXIMAL CURVE OF THE ICA. MANIPULATION OF THE STENT WAS ATTEMPTED IN AN EFFORT TO OPEN THE STENT, WHICH WAS UNSUCCESSFUL. RESHEATHING OF THE STENT WAS ADVISED AND DONE TO THE PROXIMAL NECK
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20895721 ↗
Other Intracranial coil-assist stent devices
- Neuroform Atlas M003UZAS30240Stryker Corporation · Intracranial coil-assist stent13 reports
- Neuroform Atlas M003UZAS30210Stryker Corporation · Intracranial coil-assist stent12 reports
- Neuroform Atlas M003UZAS45210Stryker Corporation · Intracranial coil-assist stent11 reports
- Neuroform Atlas M003UZAS45300Stryker Corporation · Intracranial coil-assist stent10 reports
- Neuroform Atlas M003UZAS40210Stryker Corporation · Intracranial coil-assist stent9 reports
- Stent LEV3018-PMAMicrovention, Inc. · Intracranial coil-assist stent7 reports
- Neuroform Atlas M003UZAS40240Stryker Corporation · Intracranial coil-assist stent1 death6 reports
- Neuroform Atlas M003UZAS30150Stryker Corporation · Intracranial coil-assist stent6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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