LVIS Jr. 172537-LVISJ-C-PMARecalls & reported problems
Microvention, Inc. · Stent · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429100868), received between Dec 3, 2021 and Dec 3, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Problem” (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
- Activation Problem1
Patient problems
- Ruptured Aneurysm1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2021Activation Problem; Activation Problem
IT WAS REPORTED THAT AN LVIS JR. STENT WAS USED TO TREAT A BASILAR TIP ANEURYSM AFTER IT WAS COILED. THE DISTAL TINES OF THE STENT DID NOT OPEN AND A BALLOON WAS USED TO OPEN THEM. DURING THE SECOND INFLATION ATTEMPT, THE ANEURYSM RUPTURED. THE STENT WAS LEFT IMPLANTED.
Patient problems: Ruptured Aneurysm
MAUDE report 12929808 ↗
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- 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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