LVIS Junior 172530-LVISJRecalls & reported problems
Microvention, Inc. · Low-Profile Visualized Intraluminal Support · Class f · Implant
Data updated Oct 18, 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 00811425029916), received between Jun 24, 2016 and Jun 24, 2016 — classified as 1 death.
The most frequently reported specific device problem is “Device Issue” (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.
Most reported problems
Device problems
- Device Issue1
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 24, 2016Device Issue; Device Issue
THE PATIENT WAS REPORTED TO BE AN (B)(6) FEMALE WITH A HISTORY OF INTERMITTENT VISION CHANGES SUGGESTIVE OF POSTERIOR CIRCULATION TIA. IMAGING REVEALED AN APPROXIMATELY 9.7 X 6.2 X 6.9 MM SACCULAR ANEURYSM ARISES SUPERIORLY FROM THE P1 SEGMENT OF THE RIGHT POSTERIOR CEREBRAL ARTERY. THERE IS A WIDE NECK TO THE ANEURYSM MEASURING 6.4 MM IN DIAMETER. ON 5/20/2016- REPORTED TREATMENT DESCRIPTION: FOLLOWING ACCESS, THE PATIENT DEMONSTRATED WITH AN APPROXIMATELY 6X10 MM SIZED BROAD-BASED RIGHT P1 SEGMENT ANEURYSM. AN UNSUCCESSFUL ATTEMPT WAS MADE TO INTRODUCE THE 7 MM COIL. HOWEVER, THIS WAS NOT SUCCESSFUL DUE TO THE BROAD NECK OF THE ANEURYSM. SUBSEQUENTLY IT WAS DECIDED TO PLACE THE STENT ACROSS THE ANEURYSM. THE STENT WAS SUCCESSFULLY DEPLOYED. POST STENTING ANGIOGRAM DOES NOT DEMONSTRATE ANY COMPLICATION. FOUR EMBOLIZATION COILS WERE PLACED SUCCESSFULLY. MULTIPLE CONTROL ANGIOGRAMS WERE PERFORMED. THERE ARE NO THROMBOEMBOLIC COMPLICATIONS. THE FINAL ANGIOGRAM DEMONSTRATES NO THROMBOEMBOLIC COMPLICATIONS. THE GUIDING CATHETER WAS REMOVED. THE PATIENT WAS SUCCESSFULLY EXTUBATED. THE IMMEDIATE NEURO EXAMINATION DOES NOT DEMONSTRATE ANY NEW NEUROLOGICAL DEFICITS. THE PATIENT WAS TRANSFE
Patient problems: Aneurysm; Death
MAUDE report 5748744 ↗
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- 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 ENF401612Medos International Sàrl · intracranial neurovascular stent36 reports
- CERENOVUS ENTERPRISE ENF401600Medos 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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