LifeStar® Biliary Stent VIUS14060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519005690), received between Feb 19, 2019 and May 18, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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.

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 18, 2020Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT APPROXIMATELY THREE YEAR AFTER STENT PLACEMENT IN THE RENAL VEINS, THE STENT ALLEGEDLY KINKED AND PROTRUDED THROUGH THE VEIN WALL. IT WAS FURTHER REPORTED THAT THE STENT HAD TO BE REMOVED ALONG WITH SECTIONS OF THE RENAL VEIN DUE TO THE DAMAGE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Great Vessel Perforation

  MAUDE report 10067855 ↗
• MalfunctionFeb 19, 2019Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT AFTER SUCCESSFULLY IMPLANTING THE BILIARY STENT TO TREAT STENOSIS IN A CURVED RIGHT INNOMINATE VEIN VIA ACCESS THROUGH A RIGHT BRACHIOBASILIC FISTULA AND UPON REMOVAL OF THE POST DILATATING PTA BALLOON, THE STENT ALLEGEDLY WAS PULLED BACK WITH THE BALLOON AND COLLAPSED. IT WAS FURTHER REPORTED THAT A STENT GRAFT WAS USED TO COVER THE COLLAPSED STENT AND BALLOON DILATATION WAS PERFORMED TO APOSE THE STENTS TO THE VESSEL WALL. ANOTHER DEVICE WAS USED TO COVER THE TARGET LESION AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351315 ↗