LifeStar® Biliary Stent VIUS14080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04049519005706), received between Feb 16, 2017 and Aug 11, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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

• MalfunctionAug 11, 2021Obstruction of Flow; Detachment of Device or Device Component; Obstruction of Flow; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST DEVICE IMPLANT, THE STENT ALLEGEDLY DETACHED INTO A FRAGMENT RESULTING IN DISTAL BOWEL OBSTRUCTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12305759 ↗
• InjuryAug 10, 2021Fracture; Migration or Expulsion of Device; Detachment of Device or Device Component; Fracture; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY BROKE OFF , MIGRATED AND RESULTED IN BOWEL OBSTRUCTION. IT WAS FURTHER REPORTED THAT SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE BROKEN STENT. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12299627 ↗
• MalfunctionFeb 16, 2017Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN THE RIGHT ILIAC VEIN, THE STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT'S BODY OVER A 0.035" GUIDE WIRE. AMONGST ADVANCEMENT INSIDE THE PATIENT, THE DELIVERY SYSTEM COULD NOT BE ADVANCED ANY FURTHER TO THE DESIRED LOCATION AS THERE WAS RESISTANCE BETWEEN THE GUIDE WIRE AND THE INNER LUMEN OF THE SYSTEM. THE DEVICE WAS REMOVED AND ANOTHER STENT OF THE SAME BRAND WAS USED TO FINISH THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6335910 ↗