LifeStent® Vascular & Biliary Stent EX060603CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04049519001203), received between Mar 1, 2016 and Aug 11, 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.

• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A STENT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED WITH A EXTREME PAIN, RASH, SWELLING AND ALLERGIC REACTION. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Rash; Swelling/ Edema

  MAUDE report 12307009 ↗
• InjuryMar 20, 2019Difficult or Delayed Positioning; Material Deformation; Difficult or Delayed Positioning; Material Deformation

  IT WAS REPORTED THAT DURING AN ATTEMPT TO TREAT STENOSIS IN THE RIGHT MID-SUPERFICIAL FEMORAL ARTERY (SFA) VIA CONTRALATERAL APPROACH THROUGH THE LEFT FEMORAL ARTERY THERE WAS ALLEGED DIFFICULTY TO DEPLOY THE STENT. THEREFORE, THE HEALTHCARE PROVIDER DECIDED TO RETRACT THE DELIVERY SYSTEM THROUGH THE INTRODUCER SHEATH CAUSING THE STENT TO ALLEGEDLY ELONGATE. IT WAS FURTHER ALLEGED THAT AS THE DELIVERY SYSTEM WAS PULLED BACK, THE PROXIMAL END OF THE STENT DEPLOYED, BUT DID NOT FULLY COVER THE LESION. THEREFORE, A SECOND STENT WAS REQUIRED THROUGH NEW ACCESS (RIGHT FEMORAL ARTERY) TO COVER THE INTENDED LESION. THE PATIENT WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8438962 ↗
• InjuryApr 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN UNKNOWN PERIOD OF TIME POST DEPLOYMENT OF THE STENT, THE PATIENT EXPERIENCED PAIN AND SWELLING OF THE LEFT LEG. REPORTEDLY, THE PATIENT WOULD HAVE AN ALLERGY TO NICKEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Swelling

  MAUDE report 6471244 ↗
• MalfunctionJan 5, 2017Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY DURING TREATMENT. THE DELIVERY SYSTEM WAS REMOVED WITH NO ISSUES AND ANOTHER STENT DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6225785 ↗
• MalfunctionDec 12, 2016Break; Premature Activation; Failure to Advance; Break; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT DURING ADVANCEMENT OF A 0.035" GUIDE WIRE THROUGH THE STENT DELIVERY SYSTEM, THE STENT BECAME PREMATURELY DEPLOYED. REPORTEDLY, THERE WERE NO RETRACTION ISSUES. ANOTHER DEVICE WAS USED WITH THE SAME GUIDE WIRE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 6166458 ↗
• MalfunctionMar 1, 2016Failure to Advance; Mechanical Jam

  IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS ADVANCED AND HALF WAY IT GOT STUCK. THIS DEVICE WAS THE SECOND ONE WHICH WAS USED IN THIS PATIENT AND BOTH DEVICES FAILED IN THE SAME WAY. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00062.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5470432 ↗