LVIS Junior 172516-LVISJRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811425029893), received between Jul 28, 2017 and May 26, 2018 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LVIS JR. WAS IMPLANTED DURING STENT-ASSISTED COILING OF AN ANEURYSM AT THE RIGHT MCA BIFURCATION. THERE WAS NO REPORTED DIFFICULTY DEPLOYING THE STENT AT THE TREATMENT SITE. DURING THE PROCEDURE, AN IN-STENT THROMBUS DEVELOPED AND A BALLOON WAS USED FOR TREATMENT. COILS WERE SUCCESSFULLY PLACED IN THE ANEURYSM AND THE THROMBUS WAS COMPLETELY RESOLVED BY THE END OF THE PROCEDURE. THE PATIENT WAS PLACED ON (B)(6) AS DUAL ANTIPLATELET THERAPY (DAPT), POST-PROCEDURE. ON (B)(6) 2018, APPROXIMATELY ONE MONTH AFTER THE PROCEDURE, THE PATIENT HAD A 20-MINUTE EPISODE OF LEFT ARM NUMBNESS AND DID NOT HAVE THE ABILITY TO USE HER ARM DURING THAT TIME. FIVE DAYS LATER ON (B)(6) 2018, THE PATIENT HAD A SECOND EPISODE WITH THE SAME SYMPTOMS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DETAILED IMAGING STUDIES WERE PERFORMED. IT WAS REPORTED THAT THERE WAS NO EVIDENCE BY IMAGING OF EMBOLI OR RESTRICTED BLOOD FLOW. THE PATIENT'S (B)(6) DOSAGE WAS INCREASED. A REVIEW OF IMAGES PROVIDED BY THE CUSTOMER INDICATED THE STENT DID NOT APPEAR TO BE FULLY APPOSED TO THE VESSEL WALL. THE PATIENT IS REPORTED TO BE STABLE AND HAS NOT HAD ANY RECURRENCE OF SYMPTOMS SINCE HER LAST EPISO

  Patient problems: Numbness; Thrombus

  MAUDE report 7547162 ↗
• DeathJul 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON A WIDE-NECK BASILAR ARTERY ANEURYSM OM (B)(6) 2017. FIVE COILS WERE PLACED IN THE ANEURYSM, ASSISTED BY A BALLOON. ALL COILS WERE IMPLANTED IN THE INTENDED LOCATION. AFTER PLACEMENT OF THE COILS, THE LVIS JR. STENT WAS SUCCESSFULLY DEPLOYED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED DIFFICULTY DEPLOYING THE STENT. SOMETIME AFTER THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL (ADMISSION DATE NOT PROVIDED) AND IMAGING DEMONSTRATED IN-STENT THROMBUS. ONE WEEK PRIOR TO THE PROCEDURE, THE PATIENT'S PRU WAS 190. AT THAT TIME, THE PATIENT WAS PLACED ON A DOUBLE DOSE OF PLAVIX. THE PRU ON THE DAY OF THE PROCEDURE WAS 191. THE PATIENT DIED ON (B)(6) 2017. THE PRU WAS NOT CHECKED ON THE DATE OF THE PATIENT'S DEATH. THE CAUSE OF THE DEATH IS UNKNOWN.

  Patient problems: Death; Thrombus

  MAUDE report 6752843 ↗