LVIS Jr. 172524-LVISJ-C-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429100844), received between Feb 15, 2019 and Aug 31, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionAug 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT OF A WIDE NECK BASILAR ANUERYSM USING A Y-STENT TECHNIQUE. THE 1ST LVIS JR STENT WAS PLACED IN THE RIGHT PCA AND LANDED THE STENT PROXIMALLY IN THE BASILAR ARTERY. A 45 DEGREE ANGLED MICROCATHETER WAS USED TO DELIVER THE 2ND LVIS JR IN THE LEFT PCA ARTERY USING A TRANS-CELL APPROACH THROUGH THE 1ST DEPLOYED LVIS JR STENT. AFTER THE 2ND STENT WAS DEPLOYED IN A Y CONFIGURATION, THE MICROCATHETER HAD WHAT APPEARED TO BE A LOT OF FORWARD LOAD IN IT CAUSING THE MICROCATHETER AND STENT TO ADVANCE DISTALLY THROUGH THE 2ND DEPLOYED LVIS JR STENT BODY. THE PHYSICIAN PULLED THE MICROCATHETER PROXIMALLY IN THE BASILAR ARTERY AND ATTEMPTED TO USE THE LEAD WIRE FROM THE PUSHER TO CROSS THE Y STENTS. WHEN HE PULLED THE IMPLANT PUSHER TO REMOVE THE LEAD WIRE IT APPEARED TO GET ENTANGLED IN THE 2ND LVIS JR STENT. IT WAS THOUGHT THAT JUST THE IMPLANT LEAD WIRE WAS PULLED BACK THROUGH AND INTO THE PROXIMAL BASILAR ARTERY, BUT WHEN THE WIRE WAS REMOVED, THE 2ND LVIS JR CAME OUT OF THE PATIENT ALONG WITH THE PUSHER WIRE. THE LEFT PCA ARTERY WAS RE-ACCESSED WITH A MICROCATHETER AND DEPLOYED ANOTHER 3.5 X 23 LVIS JR STENT. THIS ATTEMPT WAS SUCCESSFUL. THERE WAS NO R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15332533 ↗
• InjuryFeb 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A LEFT-SIDE, POSTERIOR COMMUNICATING ANEURYSM, THE TIP OF THE DELIVERY WIRE OF THE LVIS JR STENT DETACHED IN THE INTERNAL CAROTID ARTERY AT THE NECK OF THE BLISTER ANEURYSM. THIS WAS NOTICED AFTER THE REMAINDER OF THE LVIS STENT WAS RE-SHEATHED AND REMOVED FROM THE BODY. ANOTHER LVIS JR. STENT WAS THEN PLACED TO SECURE THE DETACHED SEGMENT OF THE STENT TO THE WALL OF THE VESSEL. THERE WAS NO REPORTED INJURY AND THE PATIENT WAS NOTED TO BE IN FAIR CONDITION POST-PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8346185 ↗