LifeStent® XL Vascular & Biliary Stent EX061003CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04049519001272), received between Oct 6, 2016 and Sep 21, 2022 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY COMPRESSED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460469 ↗
• InjuryApr 11, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT AT SOME POINT DURING IMPLANTATION OF A 6X100 VASCULAR AND BILIARY STENT IN THE ILIAC ARTERY, ALLEGEDLY AN INTERNAL PORTION OF THE CATHETER CAME OFF AND WAS RETAINED IN THE PATIENTS AORTA. THIS WAS DISCOVERED TWO YEARS AFTER STENT PLACEMENT WHEN THE PATIENT WAS HAVING AN OPEN AORTIC BI-FEMORAL BYPASS. A SMALL PLASTIC TUBE LIKE STRUCTURE WAS FOUND BY THE SURGEON IN CALCIFICATION AND CLOT, AND REMOVED FROM THE PATIENT. REPORTEDLY THE STRUCTURE IS NOT RADIOPAQUE AND UNABLE TO BE SEEN UNDER FLUOROSCOPIC EXAMINATION OR ON CT. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8507209 ↗
• MalfunctionMar 18, 2019Device Dislodged or Dislocated

  AT SOME POINT DURING THE USE OF A LIFESTENT XL VASCULAR AND BILIARY STENT IN THE FEMORAL ARTERY, AN INTERNAL PORTION OF THE CATHETER CAME OFF AND WAS RETAINED IN THE PT'S AORTA. THIS WAS DISCOVERED ON (B)(6) 2019 WHEN PT WAS HAVING AN OPEN AORTIC BI FEMORAL BYPASS. A SMALL PLASTIC TUBE LIKE STRUCTURE WAS FOUND BY THE SURGEON IN CALCIFICATION AND CLOT. THIS TUBE LIKE STRUCTURE WAS RETAINED AND EXAMINED. THE STRUCTURE IS NOT RADIOPAQUE AND UNABLE TO BE SEEN UNDER FLUOROSCOPIC EXAMINATION OR ON CT. A SIMILAR LIFESTENT XL 6 X 100 130 WAS EXAMINED AND FOUND TO CONTAIN A SIMILAR TUBE LIKE STRUCTURE ON THE INNER LUMEN OF THE STENT GUIDE. THE SURGEON WAS ABLE TO BREAK OFF THIS INNER LUMEN STRUCTURE USING SIGNIFICANT FORCE ON THE LIKE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 8432743 ↗
• MalfunctionFeb 15, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DISTAL RADIOPAQUE MARKERS WERE ALLEGEDLY NOT VISIBLE UNDER FLUOROSCOPY. THEREFORE, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8345435 ↗
• MalfunctionSep 4, 2018Malposition of Device; Material Twisted/Bent; Malposition of Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE VASCULAR STENT ALLEGEDLY JUMPED AND TWISTED AS IT WAS BEING USED TO BRIDGE A GAP AND COVER A LESION FROM A 200MM VASCULAR STENT THAT WAS PLACED AND MAL-POSITIONED DURING PLACEMENT. REPORTEDLY, A BALLOON EXPANDABLE STENT WAS USED TO STRAIGHTEN THE VASCULAR STENT, BRIDGED THE GAP, COVERED THE LESION, AND COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7844668 ↗
• MalfunctionSep 4, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE VASCULAR STENT ALLEGEDLY JUMPED APPROXIMATELY 10CM FORWARD AS IT WAS BEING DEPLOYED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH AN ANTEGRADE APPROACH. IT WAS FURTHER REPORTED THAT AN ADDITIONAL 100MM VASCULAR STENT WAS USED HOWEVER, THE STENT ALSO JUMPED AND TWISTED DURING DEPLOYMENT, MISPLACING THIS VASCULAR STENT FURTHER. THEREFORE, A BALLOON EXPANDABLE STENT WAS THEN USED TO STRAIGHTEN THE 100MM VASCULAR STENT, BRIDGED THE GAP, COVERED THE LESION, AND COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7844665 ↗
• MalfunctionJun 19, 2017Difficult to Remove; Detachment of Device or Device Component; Positioning Problem; Difficult to Remove; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT POST DEPLOYMENT OF THE STENT IN THE SFA VIA FEMORAL ACCESS, THE STENT DELIVERY SYSTEM BECAME HUNG UP. REPORTEDLY, THE TRACKING PATH WAS CALCIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6650230 ↗
• InjuryMay 31, 2017Break; Detachment of Device or Device Component; Device Operates Differently Than Expected; Break; Detachment of Device or Device Component; Device Operates Differently Than Expected

  IT WAS REPORTED THAT POST IMPLANTATION OF THE STENT IN A PRE-DILATED LESION IN THE ILIAC ARTERY VIA ACCESS THROUGH THE COMMON FEMORAL ARTERY, THE STENT WAS FOUND TO BE ELONGATED TO 200 MM. IT WAS FURTHER REPORTED THAT DURING RETRACTION OF THE GUIDE WIRE, RESISTANCE WAS FELT AND THE DISTAL TIP OF THE DELIVERY SYSTEM BROKE OFF (THE DISPOSITION OF THE FRAGMENT IS UNKNOWN; REPORTEDLY IT IS NOT IN THE PATIENT'S BODY). AS REPORTED, AN ADDITIONAL SMALL STENT VIA A SECOND ACCESS WAS PLACED AT THE TRANSITION TO THE A. PROFUNDA. THE PATIENT HAD TO BE HOSPITALIZED OVERNIGHT FOR OBSERVATION.

  Patient problems: No Known Impact Or Consequence To Patient; Vascular System (Circulation), Impaired

  MAUDE report 6602442 ↗
• InjuryApr 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER DEPLOYMENT IN THE POPLITEAL ARTERY, THE LENGTH OF THE STENT WAS MEASURED TO BE 80 MM INSTEAD OF 100 MM AS INDICATED ON THE PRODUCT LABEL. AN ADDITIONAL STENT OF 80 MM LENGTH WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE DISTAL MARKER WAS HARD TO SEE UNDER IMAGING PRIOR TO DEPLOYMENT OF THE STENT IN THE POPLITEAL ARTERY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6508682 ↗
• MalfunctionFeb 8, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY DURING AN ILIAC STENTING PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6311879 ↗
• MalfunctionOct 6, 2016Fracture; Fracture

  IT WAS REPORTED THAT THE VASCULAR STENT WAS SUSPECTED TO BE FRACTURED 12 MONTHS POST IMPLANTATION IN THE LEFT MIDDLE SFA FOR TREATMENT OF A TOTAL OCCLUSION. REPORTEDLY, THE SEVERELY CALCIFIED LESION HAD BEEN PRE-DILATED WITH A 5 MM AND A 6 MM BALLOON. FOR POST-DILATION, TWO DRUG-ELUTED BALLOONS (6 MM) AND A CONVENTIONAL BALLOON (7 MM) WERE USED. THERE WAS A RESIDUAL STENOSIS OF 20 % POST INITIAL INTERVENTION. NO ADDITIONAL TREATMENT WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6002731 ↗