LVIS 214049-LVIS-D-PMARecalls & reported problems
Microvention, Inc. · Stent · Class 3 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429100981), received between Nov 6, 2019 and Jul 21, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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
- Difficult to Fold, Unfold or Collapse1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2023Premature Separation; Premature Separation
IT WAS REPORTED THE PHYSICIAN INTENT WAS TO PLACE THE STENT IN THE DISTAL LICA. DURING THE UNSHEATHING PROCESS, THE DEVICE UNEXPECTEDLY FULLY DEPLOYED IN THE WRONG PORTION OF THE VESSEL. PHYSICIAN THEN USED A SNARE TO RECAPTURE AND RETRIEVE THE DEVICE WITHOUT INCIDENT. THE PHYSICIAN DECIDED TO COIL THE ANEURYSM INSTEAD. PATIENT RECOVERED FROM PROCEDURE SATISFACTORILY AND NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17368568 ↗InjuryNov 6, 2019Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
A USER FACILITY MEDWATCH REPORT PROVIDED TO THE MANUFACTURER STATED, "THERE WAS INCOMPLETE EXPANSION OF THE LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT (LVIS) INTRALUMINAL SUPPORT DEVICE WHICH PROMOTED ACCUMULATION OF THROMBUS AT THE DISSECTION SITE AND WITH INABILITY TO TRAVERSE THE DEVICE TO AFFECT DEPLOYMENT."
Patient problems: Thrombus
MAUDE report 9288740 ↗
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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