LVIS 212928-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
- 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 00816777026019), received between Oct 28, 2024 and Sep 11, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Activation Failure” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Failure1
- Adverse Event Without Identified Device or Use Problem1
- Retraction Problem1
Patient problems
- Extravasation1
- No Clinical Signs, Symptoms or Conditions1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MalfunctionOct 28, 2024Retraction Problem; Activation Failure; Retraction Problem; Activation Failure
AS REPORTED THROUGH THE CLINICAL STUDY LVIS PAS: AE/EVENT TERM: DIFFICULTY GETTING THE PROXIMAL ASPECT OF THE DEVICE TO OPEN DUE TO SEVERE TORTUOSITY. INDEX PROCEDURE SUMMARY: DURING THE INDEX PROCEDURE ON (B)(6) 2018 TO TREAT LARGE, WIDE-NECKED OPHTHALMIC ICA ANEURYSM, LVIS 4X28 WAS DEPLOYED FROM THE ICA TERMINUS, ACROSS THE NECK OF THE ANEURYSM WHERE THE DEVICE WAS PACKED IN, AND ULTIMATELY INTO THE CAVERNOUS SEGMENT OF THE ICA. GIVEN SEVERE TORTUOSITY, SOME DIFFICULTY OCCURRED WITH GETTING THE PROXIMAL ASPECT OF THE DEVICE TO OPEN. IT WAS DECIDED TO COMPLETE THE COILING PORTION OF THE PROCEDURE TO ADDRESS THE PROXIMAL ASPECT OF THE DEVICE WITHOUT HAVING AN ADJACENT MICROCATHETER PRESENT. AFTER FULLY DEPLOYING AND DETACHING THE 9X30, COILING PROCEED WITH 5 ADDITIONAL AXIUM COILS AS FOLLOWS: 7X30 3D, 6X20 3D PRIME, 5X15 3D PRIME, 4X12 3D PRIME, 3X10 3D. THE ECHELON WAS THEN REMOVED. A SCEPTER XC 4X11 BALLOON WAS ADVANCED OVER A SYNCHRO WIRE IN AN ATTEMPT TO ANGIOPLASTY THE PROXIMAL ASPECT OF THE LVIS. GIVEN THE ACUITY OF THE ANGLES, COULD NOT SELECT THE INTERIOR OF THE DEVICE; HOWEVER, MANIPULATED THE BALLOON ALONGSIDE DEVICE. THIS PROVIDED ENOUGH FORWARD FORCE TO PUSH THE PROXIMA
Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus
MAUDE report 20553177 ↗
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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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