LVIS 213015-LVIS-D-HDERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812636022208), received between Sep 14, 2016 and Oct 15, 2025 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (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.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY THAT THE SUBJECT UNDERWENT SURGICAL PROCEDURE OF COILING FOR "RECANALIZATION OF TARGET ANEURYSM" APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE. INDEX PROCEDURE WAS (B)(6) 2018 AND THE SUBJECT UNDERWENT SUCCESSFUL BALLOON ASSISTED, LVIS STENT ASSISTED COIL EMBOLIZATION OF A RUPTURED POSTERIOR COMMUNICATING ARTERY. IT WAS REPORTED THAT THE SUBJECT OUTCOME WAS "METASTASIS" DIAGNOSED ON (B)(6) 2021 WITH OUTCOME OF DEATH ON (B)(6) 2021. THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2021 WITH COMPLAINTS OF CONSTIPATION, VERY POOR PER ORAL INTAKE. METASTASIS LED TO ABDOMINAL ASCITES AND CONSTIPATION COMPLICATED BY ACUTE KIDNEY INJURY, HYPERKALEMIA, HYPONATREMIA AND SEPSIS. THE PATIENT MEDICAL HISTORY IS REPORTED AS: HYPERTENSION, CHRONIC ANEMIA, HISTORY OF HOSPITALIZATION FOR EVALUATION OF MULTIPLE LUNG NODULES AND LIVER MASS.

  Patient problems: Aneurysm expansion

  MAUDE report 23306337 ↗
• MalfunctionNov 22, 2024Structural Problem; Structural Problem

  AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: INCOMPLETE OPEN OF THE LVIS DEVICE PROXIMAL TO THE ANEURYSM. AFTER THE DEPLOYMENT OF THE STENT, IT APPEARED THAT THE PROXIMAL END OF THE STENT DID NOT OPEN FULLY. THE EVENT (INCOMPLETE OPENING OF THE LVIS) OCCURRED AFTER DETACHMENT OF THE STENT. SUBJECT WITH INDEX PROCEDURE WAS NOTED TO HAVE INCOMPLETE OPENING OF THE LVIS DEVICE PROXIMAL TO THE ANEURYSM. AFTER THE DEPLOYMENT OF THE STENT, IT APPEARED THAT THE PROXIMAL END OF THE STENT DID NOT OPEN FULLY. SITE REPORTED THE DEVICE MALFUNCTION OCCURRED DURING INTRA-PROCEDURE STAGE OF THE INDEX PROCEDURE. THE EVENT WAS NOT ASSOCIATED WITH ANY ADVERSE EVENT. IT DID NOT REQUIRE ANY TREATMENT/INTERVENTION AS A RESULT OF THE MALFUNCTION/DEFICIENCY. SUBJECT STATUS AFTER THE INDEX PROCEDURE OF LVIS: ON THE DAY OF INDEX PROCEDURE, PATIENT WAS FOUND TO BE HEMIPARETIC ON THE LEFT ARM AND LEG. WEAKNESS IMPROVED QUICKLY, MINIMAL WEAKNESS WAS AT DISCHARGE. NO TREATMENT WAS REQUIRED. SUBJECT WAS DISCHARGE FROM HOSPITAL A DAY AFTER INDEX PROCEDURE. SITE REPORTED THE ADVERSE EVENT AS: LEFT SIDED WEAKNESS - MODERATE SEVERITY, NOT A SERIOUS ADVERSE EVENT, UNKNOWN RELATEDNESS TO DEVICE/INDEX PROCEDURE, WI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758615 ↗
• DeathSep 14, 2016Mechanical Problem; Difficult to Open or Close

  IT WAS REPORTED THE PATIENT PRESENTED WITH A RUPTURED SAH. IT WAS DETERMINED THAT THE RIGHT ARTERY WAS THE VESSEL THAT MOST LIKELY RUPTURED DUE TO PREVIOUS IMAGING. A DUO 156 WAS JAILED IN THE ANEURYSM. THIS WAS SUBSEQUENTLY REMOVED. A 4.5 X23 LVIS DEVICE WAS PLACED THROUGH A HEADWAY 21 MICROCATHETER. IT WAS ADVANCED AND PROPERLY POSITIONED FOR DEPLOYMENT WITH NO ISSUES. THE DISTAL END OF STENT OPENED WITHOUT ISSUES. UPON GOING AROUND THE CURVE THE STENT WOULD NOT OPEN. THE STENT WAS RESHEATHED AND ANOTHER ATTEMPT WAS MADE. SAME ISSUE OCCURRED AT EXACTLY THE SAME SPOT IN THE CURVATURE OF THE VESSEL. STENT WAS RESHEATHED AND REMOVED FROM PATIENT. A SECOND LVIS DEVICE WAS ATTEMPTED. THE MICROCATHETER AND STENT WERE PLACED PROPERLY AND DEPLOYMENT WAS ATTEMPTED AGAIN. THE STENT WAS DEPLOYING DISTALLY BUT APPEARED NOT TO BE OPENING ALL THE WAY. DURING SECOND ATTEMPT, THE COMPONENTS OF THE STENT CAME APART. THE STENT WAS RESHEATHED AND REMOVED. IT APPEARS THE EXPOSED GUIDE CAUSED A RUPTURE OF THE SECOND ANEURYSM. TO CONTROL THE BLEEDING AN ARTERY HAD TO BE PERMANENTLY OCCLUDED, THUS BLOCKING BLOOD FLOW TO AREAS OF THE BRAIN FED BY THIS ARTERY. THE THIRD ATTEMPT WAS MADE WITH AN ENTERPRIS

  Patient problems: Aneurysm; Death

  MAUDE report 5950521 ↗