LVIS 212931-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
- 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 00842429100936), received between Apr 2, 2026 and Apr 2, 2026 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Headache1
- Obstruction/Occlusion1
- Stroke/CVA1
- Thrombosis/Thrombus1
- Transient Ischemic Attack1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY THERE ARE 3 AE'S HAVE BEEN REPORTED FOR SUBJECT (B)(6) AT SITE USA-06. AN AE HAS BEEN REPORTED FOR SUBJECT (B)(6) AT SITE USA-06. BELOW AE WAS ADJUDICATED ON 10MAR2026 AS STUDY DEVICE-RELATED, STUDY PROCEDURE-RELATED STUDY: LVIS PAS (RETROSPECTIVE STUDY): AE #1 NAME: TRANSIENT OCCLUSION OF RIGHT MCA. EVENT ONSET DATE: 31-OCT-2018. EVENT DESCRIPTION: TRANSIENT OCCLUSION OF RIGTH MCA WITH RESTORATION OF NORMAL FLOW AFTER INFUSION THERAPY FOR THROMBOLYSIS. DATE OF INDEX PROCEDURE: (B)(6) 2018 IS THE EVENT A SERIOUS ADVERSE EVENT: NO. OUTCOME: RESOLVED WITHOUT SEQUELAE. DOES THE EVENT MEET CRITERIA FOR AN UNANTICIPATED ADVERSE DEVICE EFFECT: NO. THE PATIENT OUTCOME WAS BASED ON DISCHARGE SUMMARY ON (B)(6) 2018 PATIENT WORKED WITH PT/OT AND DID WELL ENOUGH TO BE DISCHARGED HOME WITH SUPERVISION. HAS HEADACHES WHICH WILL BE MANAGED CONSERVATIVELY. BELOW AE # 4 WAS ADJUDICATED ON (B)(6) 2026 AS STUDY DEVICE-RELATED, STUDY PROCEDURE-RELATED. STUDY: LVIS PAS (RETROSPECTIVE STUDY): AE #4 NAME: HYPOPERFUSION. EVENT ONSET DATE: 14-MAR-2019. EVENT DESCRIPTION: HYPOPERFUSION EVENT RELATED TO RIGHT CAROTID OCCLUSION. PRESENTED AS A MINOR STROKE WITH
Patient problems: Headache; Obstruction/Occlusion; Stroke/CVA; Thrombosis/Thrombus; Transient Ischemic Attack
MAUDE report 24772272 ↗
Other Intracranial Coil-Assist Stent devices
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- 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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