Stent LEV3528-PMARecalls & reported problems
Microvention, Inc. · LVIS EVO · Class 3 · Implant
All models of Stent (63)
Data updated Oct 18, 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 00842429117842), received between Mar 7, 2025 and Mar 7, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Open or Close” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close1
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.
InjuryMar 7, 2025Difficult to Open or Close; Difficult to Open or Close
AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY: RELATIONSHIP TO STUDY DEVICE: THE WEB IS NOT RELATED (LVIS EVO IS NOT THE STUDY DEVICE). RELATIONSHIP TO STUDY PROCEDURE: NOT RELATED RELATIONSHIP TO LVIS EVO: CAUSAL NOTE: THIS IS NARROWING IN THE LVIS EVO STENT WHICH WAS PLACED FOR NON-TARGET ANEURYSM. EVENT TERM : FOCAL NARROWING WITHIN LVIS EVO STENT. AE OUTCOME : RECOVERED/RESOLVED. RECOVERED/RESOLVED: DATE OF RESOLUTION : (B)(6) 2025. ADDITIONAL INFORMATION INDICATED: A 3.5MMX28MM LVIS EVO WAS DEPLOYED ACROSS THE NECK OF A NON-TARGET (R ACA A1-A2 JUNCTION) ANEURYSM. A FOCAL AREA OF NARROWING WAS NOTED WITHIN THE MIDPORTION OF THE LVIS EVO STENT WAS TREATED BY PLACING A NEUROFORM ATLAS ACROSS THE NARROWING RESULTING IN EXCELLENT WALL TO STENT APPOSITION AND RESOLUTION OF THE MID-STENT NARROWING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21554577 ↗
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 M003UZAS30150Stryker Corporation · Intracranial coil-assist stent6 reports
- Neuroform Atlas M003UZAS40240Stryker Corporation · Intracranial coil-assist stent1 death6 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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