LVIS 212922-LVIS-D-HDERecalls & reported problems
Microvention, Inc. · Stent · Class f · Implant
All models of LVIS (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777026002), received between Feb 16, 2018 and Feb 16, 2018 — classified as 1 injury.
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
- Thrombosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT STENT-ASSISTED COILING OF A SUPRACLINOID LEFT INTERNAL CAROTID ARTERY ANEURYSM WAS PERFORMED. THE PATIENT WAS PREMEDICATED WITH DUAL ANTIPLATELET THERAPY (ASPIRIN AND CLOPIDOGREL). HEPARIN WAS ADMINISTERED FOLLOWING SHEATH PLACEMENT AND AT ONE-HOUR INTERVALS (9000U TOTAL). THE LVIS STENT WAS SUCCESSFULLY DEPLOYED WITHOUT INCIDENT AND COILS WERE IMPLANTED IN THE ANEURYSM. ANGIOGRAMS TAKEN AFTER COIL PLACEMENT DEMONSTRATED A SUBTLE FILLING DEFECT SUGGESTIVE OF ACUTE IN-STENT THROMBOSIS IN THE DISTAL CAVERNOUS LEFT INTERNAL CAROTID ARTERY (LICA). A 180 MCG/KG IV BOLUS OF EPTIFIBATIDE WAS ADMINISTERED. AFTER TEN (10) MINUTES, A REPEAT ANGIOGRAM NOTED NEARLY COMPLETE CLOT LYSIS. A 2 MCG/KG/MIN IV OF EPTIFIBATIDE WAS CONTINUED FOR TWELVE (12) HOURS TO MAINTAIN STENT PATENCY.
Patient problems: Thrombosis
MAUDE report 7277414 ↗
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- 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.
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