LVIS 212517-LVIS-D-HDERecalls & reported problems
Microvention, Inc. · Stent · Class f · Implant
All models of LVIS (17)
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 00812636022185), received between Dec 15, 2023 and Feb 23, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Ischemia Stroke1
- Numbness1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY THAT THE FOLLOWING AE FOR AN LVIS SUBJECT WAS ADJUDICATED BY CEC STUDY DEVICE-RELATED: LEFT MCA ISCHEMIC STROKE ON POD 293. THE PATIENT REPORTED THAT THEIR PENMANSHIP HAS BEEN AFFECTED BY RIGHT HAND NUMBNESS. THE LEFT MCA ISCHEMIC STROKE WAS TREATED WITH PLAVIX AND COUMADIN. BASED ON THE REVIEW OF DISCHARGE NOTE, SUBJECT HAD ONGOING SYMPTOMS OF RIGHT-HAND NUMBNESS AS OF THEIR DISCHARGE DATE (B)(6) 2021.
Patient problems: Ischemia Stroke; Numbness
MAUDE report 24424478 ↗InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH A LVIS PAS CLINICAL TRIAL, DURING THE INDEX PROCEDURE IMMEDIATELY AFTER THE 3RD COIL WAS PLACED, THE SURGICAL TEAM NOTICED PROGRESSIVE NARROWING IN THE MIDPORTION OF THE STENT WITH IRREGULAR MARGINS SUGGESTIVE OF THROMBUS FORMATION. A REPEAT ANGIOGRAPHY WAS PERFORMED, AND IT CONFIRMED THE THROMBUS FORMATION. THE PATIENT WAS TREATED WITH INTEGRILIN INTRAARTERIALLY OVER 5 MINUTES. POST-INTEGRILIN ANGIOGRAPHY DEMONSTRATED IMPROVED FLOW ACROSS THE STENT, WITH PERSISTENT NONOCCLUSIVE THROMBUS WITHIN THE MIDPORTION. ADDITIONAL INTEGRILIN WAS ADMINISTERED AND FLOW WAS IMPROVED FURTHER. THE THROMBUS IS STATED TO BE RELATED TO THE STUDY DEVICE AND INDEX PROCEDURE. THE THROMBUS RESOLVED WITHOUT SEQUELAE.
Patient problems: Thrombosis/Thrombus
MAUDE report 18337946 ↗
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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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