Stent LEV3522-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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429117835), received between Feb 25, 2025 and Feb 7, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Stroke/CVA2
- Speech Disorder1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2026Migration
IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A BASILAR ANEURYSM. THE STENT WAS DEPLOYED FROM THE LEFT PCA INTO THE BASILAR ARTERY USING A MICROCATHETER AND THE STENT DEPLOYED ADEQUATELY. THE PHYSICIAN LEFT THE PUSHER WIRE IN THE STENT AND THE MICROCATHETER BELOW THE STENT. DURING AN INJECTION, THE PUSHER WIRE AND THE MICROCATHETER MOVED UP PUSHING THE PROXIMAL STENT ALL THE WAY INTO THE ANEURYSM. ATTEMPTS TO SNARE THE STENT WERE UNSUCCESSFUL. A COMPETITOR STENT WAS THEN DEPLOYED INTO THE RIGHT PCA INTO THE BASILAR ARTERY. THE PHYSICIAN THEN COILED THE ANEURYSM AND WAS FOLLOWED BY PLACEMENT OF AN ADDITIONAL STENT AND FURTHER COILING. THE PATIENT LATER DEVELOPED A STROKE THAT EVENING. ADDITIONAL CLARIFYING INFORMATION PROVIDED INDICATED THAT DURING A DSA RUN, THE PUSHER WIRE AND MICROCATHETER MOVED FORWARD PUSHING THE STENT INTO THE ANEURYSM. THE PATIENT HAS BEEN ON INTEGRILIN SINCE THAT DAY AS THEY BELIEVE THROMBUS IS IN THE STENT AND IS CURRENTLY IN THE ICU.
Patient problems: Stroke/CVA; Thrombosis/Thrombus
MAUDE report 24285451 ↗InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD A CRANIOPLASTY. THE PATIENT STILL HAS APHASIA AND IS RECEIVING SPEECH THERAPY. THE EVENT DATE WAS PROVIDED AS AUGUST 21, 2024.
Patient problems: Speech Disorder; Stroke/CVA
MAUDE report 21465574 ↗
Other Intracranial coil-assist stent devices
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- 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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