LifeStent® XL Vascular & Biliary Stent EX071203CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04049519001319), received between Mar 1, 2016 and Sep 10, 2021 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2021Loss of or Failure to Bond; Break; Positioning Failure; Premature Activation; Loss of or Failure to Bond; Break; Positioning Failure; Premature Activation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY AND THE HOUSING SHEATH WOULD NOT COME BACK TO DEPLOY THE STENT. IT WAS FURTHER REPORTED THAT THE STENT WAS DEPLOYED IN THE SHEATH AND THE PHYSICIAN DECIDED TO REMOVE THE SYSTEM UPON REMOVING THE DEPLOYMENT SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453009 ↗
• MalfunctionJun 3, 2021Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929151 ↗
• InjuryOct 21, 2019Fracture; Difficult to Remove; Misfire; Fracture; Difficult to Remove; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE STENT ALLEGEDLY PARTIALLY DEPLOYED AND FRACTURED IN HALF. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULT RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT BUT A SEGMENT OF THE FRACTURED STENT WAS REMOVED WITHOUT INCIDENT. AN ATTEMPT WAS MADE TO RETRIEVE THE REMAINING FRAGMENT WAS UNSUCCESSFUL. REPORTEDLY, ANOTHER STENT ALONG WITH ADDITIONAL BALLOON DILATATION WAS USED TO APOSE THE REMAINING STENT FRAGMENT TO THE VESSEL WALL AND COVER THE LESION TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTEDLY STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9215224 ↗
• InjuryNov 2, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED DURING DEPLOYMENT IN PROXIMAL COMMON ILIAC VIA BILATERAL GROIN, THE STENT WAS ALLEGEDLY JUMPED INTO DISTAL AORTA. IT WAS FURTHER REPORTED THAT PATIENT WAS SCHEDULED FOR SURGERY TO RETRIEVE THE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8035515 ↗
• MalfunctionMay 17, 2017Break; Difficult or Delayed Positioning; Device Operates Differently Than Expected; Break; Difficult or Delayed Positioning; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE DELIVERY SYSTEM TO A SEVERELY CALCIFIED LESION IN THE EXTERNAL ILIAC ARTERY VIA THE RIGHT GROIN AND DURING DEPLOYMENT OF THE STENT, RESISTANCE WAS FELT. THEREFORE, THE DELIVERY SYSTEM WAS PULLED BACK AND THE STENT WAS DEPLOYED BUT APPEARED TO BE FORESHORTENED. AN ADDITIONAL STENT WAS PLACED IN OVERLAP WITH THE FIRST STENT TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6572074 ↗
• InjuryMar 1, 2016Material Torqued; Material Twisted/Bent; Collapse; Positioning Failure; Material Rupture; Material Torqued; Material Twisted/Bent

  IT WAS REPORTED THAT POST DEPLOYMENT OF THE VASCULAR STENT IN THE LEFT SFA, THE STENT ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT A GUIDE WIRE WAS RAN THROUGH THE MIDDLE OF THE STENT AND A BALLOON CATHETER WAS USED TO OPEN THE STENT, BUT THE BALLOON RUPTURED AND THE ATTEMPT WAS UNSUCCESSFUL. REPORTEDLY, ANOTHER VASCULAR STENT WAS ADVANCED TO THE SITE AND WAS SUCCESSFULLY DEPLOYED WITHIN THE FIRST STENT. THERE WAS NO REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5471722 ↗