LVIS Junior 172524-LVISJRecalls & reported problems
Microvention, Inc. · Low-Profile Visualized Intraluminal Support · Class f · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811425029909), received between Jun 28, 2016 and Jun 28, 2016 — classified as 1 death.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Aneurysm1
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJun 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REPORTED TO BE A (B)(6) YEAR OLD FEMALE WITH A HISTORY OF PREVIOUSLY TREATED SAH (2). ONE ANEURYSM HAD BEEN COILED AND ONE CLIPPED. NO ADDITIONAL INFORMATION PROVIDED FOR THESE PREVIOUS TREATMENTS. THE PATIENT WAS CURRENTLY BEING TREATED FOR A WIDE NECK ANEURYSM PROXIMAL TO THE M1/A1 BIFURCATION IN THE DISTAL CEREBRAL CAROTID ARTERY. THE TREATMENT PLAN WAS TO DEPLOY A STENT AT THE BIFURCATION TO PRESERVE EASY ACCESS TO THE M1 AND A1. THE FIRST TWO DEPLOYMENTS WERE UNSUCCESSFUL DUE TO LOSING CATHETER ACCESS AND PARTIAL STENT OPENING. THESE DEVICES WERE WITHDRAWN AS INDICATED. THE INTENDED LANDING SPOT DID NOT SEEM TO BE POSSIBLE, SO A NEW LANDING ZONE IN THE M1 WAS CHOSEN. THE LVIS JR 3.5X23 WAS INSERTED. THE STENT WAS DEPLOYED ACROSS THE NECK OF THE ANEURYSM WITH A SECOND MICROCATHETER POSITIONED IN THE ANEURYSM. THE STENT WAS BUTTRESSED AT THE NECK TO PROVIDE MAXIMUM COVERAGE AND THE STENT WAS DEPLOYED. THE ANEURYSM WAS COILED SUCCESSFULLY. MULTIPLE CT RUNS WERE TAKEN THROUGHOUT THE PROCEDURE AND NO COMPLICATIONS WERE OBSERVED. FOLLOWING THE SUCCESSFUL COMPLETION OF THE CASE, REMOVAL OF THE SHEATH, AND CLOSURE OF THE FEMORAL ARTERY THE PATIENT PRESENTED WITH SYMPTO
Patient problems: Aneurysm; Death
MAUDE report 5755948 ↗
Other Intracranial Neurovascular Stent devices
- CERENOVUS ENTERPRISE ENF402312Medos International Sàrl · intracranial neurovascular stent1 death90 reports
- PulseRider Aneurysm Neck Reconstruction Device 201-DMedos International Sàrl · Intracranial Neurovascular Stent2 deaths74 reports
- CERENOVUS ENTERPRISE ENF402300Medos International Sàrl · intracranial neurovascular stent2 deaths66 reports
- CERENOVUS ENTERPRISE ENF403012Medos International Sàrl · intracranial neurovascular stent1 death42 reports
- CERENOVUS ENTERPRISE ENF452212Medos International Sàrl · intracranial neurovascular stent41 reports
- CERENOVUS ENTERPRISE ENF401600Medos International Sàrl · intracranial neurovascular stent36 reports
- CERENOVUS ENTERPRISE ENF401612Medos International Sàrl · intracranial neurovascular stent36 reports
- CERENOVUS ENTERPRISE ENF452812Medos International Sàrl · intracranial neurovascular stent31 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.
How reports and recalls are matched · Editorial policy · Report an error on this page