LVIS 213041-LVIS-D-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429100967), received between Jan 15, 2021 and Nov 7, 2025 — classified as 2 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem

  AS REPORTED VIA THE LVIS PAS CLINICAL STUDY: THIS FILE CAPTURES THE SECOND STENT USED IN THE CASE. DURING INDEX PROCEDURE ON (B)(6) 2017, MICROWIRE WAS THEN REMOVED AND THE FIRST OF THE TWO FLOW DIVERTING STENTS WAS THEN LOADED AND APPLIED IN THE FOLLOWING MANNER. FIRST PART OF THE STENT WAS PUSHED OUT OF THE CATHETER SUCH THAT GOOD DISTAL WALL APPOSITION WAS OBTAINED. THE REST OF THE STENT WAS THEN GENTLY PUSHED OUT OF THE CATHETER BUCKFIELD OPEN COMPLETELY IN THE SUPRA-CLINOID ICA SEGMENT, THEN "WAGGED" THE CONSTRUCT A FEW TIMES UNTIL IT OPENED FULLY AND CONTINUED DEPLOYING THE REMAINDER OF THE DEVICE. FOLLOW UP RUNS REVEAL INCOMPLETE STENT APPOSITION ALONG THE ANTERIOR OPHTHALMIC AND CLINOID SEGMENTS. WE THEN USED A J-WIRE TO BUMP THE STENT OPEN AND ALSO GAIN DISTAL ACCESS FOR THE SECOND DEVICE. FOLLOW UP ANGIOGRAPHY AFTER THIS MANEUVER REVEALED COMPLETE APPOSITION OF THE STENT BUT PERSISTENT ANEURYSM FILLING. WE THEN LOADED THE SECOND DEVICE AND STARTED DEPLOYING IT BUT, YET AGAIN, HAD TROUBLE WITH INCOMPLETE OPENING. THE ABOVE-MENTIONED PROCEDURE ¿WAGGING¿ WAS REPEATED WITH ONLY PARTIAL SUCCESS. THE DEVICE WAS CONTINUED BEING DEPLOYED BUT HAD TO REACH SHEATH IT NUMEROUS TIMES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23499333 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE LVIS PAS CLINICAL RETROSPECTIVE STUDY: DATE OF INDEX PROCEDURE: ON (B)(6) 2021. ORIGINALLY REPORTED: AE NAME: BASILAR ANEURYSM RESIDUAL/RECURRENCE. EVENT ONSET DATE: 13-NOV-2023. RELATEDNESS: UNKNOWN RELATIONSHIP. IS THE EVENT A SERIOUS ADVERSE EVENT? YES. OUTCOME: ONGOING. UPDATED AE WAS ADJUDICATED BY CEC ON (B)(6) 2025 AS STUDY DEVICE-RELATED. THE FOLLOWING UPDATED INFORMATION IS NOTED: ADJUDICATED ADVERSE EVENT TERM: ANEURYSM RETREATMENT. EVENT CATEGORY: ADVERSE EVENT. SERIOUS ADVERSE EVENT? YES. REASON(S) FOR SERIOUSNESS: MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. SEVERITY: GRADE 3: SEVERE (SAE) - SEVER OR MEDICALLY SIGNIFICANT BUT NOT IMMEDIATELY LIFE-THREATENING, HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION INDICATED. AE RELATEDNESS: STUDY DEVICE -RELATED & DISEASE RELATED. SPECIFY AE CATEGORY: NEUROLOGIC. WAS THE EVENT ASSOCIATED WITH A NEUROLOGICAL DEFICIT? NO. SPECIFY THE EVENT LOCATION: CANNOT ASCERTAIN. WAS THE EVENT A TIA? NO. WAS THE EVENT A STROKE? NO. WAS THERE A TARGET ANEURYSM REBLEED? NO. DOES THIS EVENT QUALIFY AS A CLINICAL OUTCOME?

  Patient problems: Aneurysm expansion

  MAUDE report 21886670 ↗
• MalfunctionJan 15, 2021Activation Failure

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF AN LVIS IN THE INTERNAL CAROTID ARTERY (ICA) TO TREAT A RUPTURED ANEURYSM, THE PROXIMAL MARKERS OF THE STENT DID NOT OPEN. THE MARKERS COULD NOT BE OPENED WITH THE CATHETERS. NO ADDITIONAL INTERVENTION WAS PERFORMED. FINAL ANGIOGRAPHY DEMONSTRATED A MOSTLY PATENT ICA AND THE ANEURYSM WAS SUCCESSFULLY COILED. THERE WAS NO REPORTED PATIENT INJURY OR SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11182426 ↗