LVIS Jr. 172516-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 00842429100837), received between Oct 19, 2021 and Jun 2, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Activation Failure” (2 reports).
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
- Activation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2023Activation Failure; Activation Failure
IT WAS ORIGINALLY REPORTED DURING M1 ANEURYSM RETREATMENT, A STENOSIS WAS PRESENT AT THE LEVEL OF THE NECK. THE STRATEGY WAS TO JAIL A CATHETER, ADD COIL AND DEPLOY A STENT IN FRONT OF THE ANEURYSM NECK. THE STENT WAS PARTIALLY DEPLOYED, AND A COIL WAS INSERTED IN THE ANEURYSM SAC. THE COIL WAS DETACHED, AND THE STENT FULLY DEPLOYED. THE PHYSICIAN NOTICED THAT THE STENT WAS NOT FULLY OPEN PROXIMALLY. THE PHYSICIAN TRIED TO NAVIGATE A COMPLIANT BALLOON IN THE STENT TO OPEN THE STENT BUT NO POSSIBILITY TO ACCESS THE PROXIMAL ENTRY OF THE STENT. A TENTATIVE OF SNARE WAS DONE WITH A 2MM AND 4MM SNARE BUT NOT POSSIBLE TO GRAB THE PROXIMAL PART OF THE STENT. THE STENT WAS LEFT IN PLACE PARTIALLY OPEN WITH A GOOD FLOW IN MCA. ADDITIONAL INFORMATION RECEIVED NOTES THAT ON (B)(6) 2023, THE PATIENT HAD PRESSURE DEPENDENT NEGLECT THAT IMPROVED WITH CANGRELOR AND PERMISSIVE HTN. AS OF (B)(6) 2023, PATIENT IS BETTER AND WILL PROBABLY BE DISCHARGED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17052137 ↗InjuryOct 19, 2021Activation Failure; Activation Failure
IT WAS REPORTED THAT AFTER DEPLOYING THE LVIS JR. STENT, THE BACK HALF OF THE STENT LEADING TO THE PROXIMAL END DID NOT OPEN AND APPEARED FLATTENED OUT. THE STENT WAS REMOVED WITH A SNARE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12662138 ↗
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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