LVIS Jr. 172020-LVISJ-C-PMARecalls & reported problems
Microvention, Inc. · Stent · Class 3 · Implant
Data updated Oct 18, 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 00842429100813), received between Jul 31, 2018 and May 8, 2019 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Thrombus2
- Neurological Deficit/Dysfunction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY TWO (2) HOURS POST STENT-IMPLANTATION, THE PATIENT PRESENTED WITH NEUROLOGICAL DECLINE AND LEFT HEMISPHERE SYNDROME. CTA DEMONSTRATED A THROMBOTIC OCCLUSION OF THE UPPER BRANCH OF THE STENT CONSTRUCT. THE PATIENT WAS TREATED WITH IA INTEGRELIN. THE EVENT WAS RESOLVED WITHOUT SEQUELAE THREE (3) DAYS LATER. THE PATIENT WAS REPORTED TO HAVE MADE A COMPLETE RECOVERY.
Patient problems: Neurological Deficit/Dysfunction; Thrombus
MAUDE report 8593173 ↗InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOUR (4) COILS WERE SUCCESSFULLY IMPLANTED IN AN A2 CALLOSOMARGINAL ANEURYSM. AFTER IMPLANTATION OF A SUBSEQUENT STENT, THE PATIENT DEVELOPED A CLOT WITHIN THE DISTAL PORTION OF THE STENT, WHICH SHUT DOWN DISTAL FLOW IN THE VESSEL. REOPRO WAS ADMINISTERED, AND THE CLOT RESOLVED. THE PATIENT WAS REPORTED TO HAVE WOKEN UP WITH NO SYMPTOMS, AND IS DOING GREAT.
Patient problems: Thrombus
MAUDE report 7737762 ↗
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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