Express® LD Iliac / Biliary H74938046760750Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729392231), received between Mar 7, 2018 and Jul 6, 2021 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2021Migration; Migration

  IT WAS REPORTED THAT DEVICE MIGRATION OCCURRED AND SURGICAL INTERVENTION WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE ILIOFEMORAL ARTERY. A 7.0X60X75CM AND A 7.0X40X75CM EXPRESS LD ILIAC / BILIARY STENTS WERE IMPLANTED FOR TREATMENT. HOWEVER, DURING WITHDRAWAL, DEVICE MIGRATION OCCURRED AND THE SURGICAL FEMORALE CUT DOWN WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PATIENT COMPLICATIONS REPORTED. THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122628 ↗
• MalfunctionJun 30, 2021Difficult to Advance; Material Deformation; Material Integrity Problem; Difficult to Advance; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 7.0X60X75CM EXPRESS LD ILIAC / BILIARY WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT THE STENT STRUTS WERE FLARED AND WAS NOT ABLE TO ADVANCE INTO THE SHEATH. WHEN THE PHYSICIAN TRIED TO ADVANCED THE DEVICE, THE DISTAL TIP WAS BUCKLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096245 ↗
• InjuryJun 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN NON-TORTUOUS AND SEVERELY CALCIFIED LEFT ILIAC ARTERY. A 7.0 X 60 X 75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED. HOWEVER, DURING PROCEDURE THE STENT DETACHED FROM STENT DELIVERY SYSTEM (SDS). THE PHYSICIAN REMOVED THE SDS INTACT. AN ARTERIAL ACCESS WAS THEN PERFORMED VIA IPSILATERAL GROIN APPROACH. AFTER A 018 GUIDEWIRE WAS CROSSED THE LESION, A 8 X 27MM EXPRESS LD WAS DEPLOYED. DILATATION WAS PERFORMED WITH A 6 X 40 STERLING BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970938 ↗
• MalfunctionJun 26, 2020Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON INVESTIGATION COMPLETED ON 19JUN2020. IT WAS REPORTED THAT ADVANCING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 7.0X60X75CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED FOR USE. HOWEVER, THE PHYSICIAN COULD NOT ADVANCE THE STENT THROUGH THE SHEATH DUE TO SEVERE SCARRING AT THE ENTRY SITE. BOTH THE DEVICE AND THE SHEATH WAS REMOVED AND ANOTHER 7FR SHEATH WAS USED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, INVESTIGATION REVEALED STENT DAMAGE AND STENT MOVED ON BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10200079 ↗
• InjuryFeb 26, 2019Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH MW5083153, THAT THE STENT BROKE. AN EXPRESS LD 7.0X60X75CM STENT WAS SELECTED FOR A PROCEDURE IN THE PATIENT'S LEG. ON (B)(6) 2013, THE PATIENT PRESENTED WITH A LIFE THREATENING BLOOD CLOT. THE PATIENT WAS ADMITTED FOR EMERGENCY SURGERY. THE EXPRESS LD STENT AND A NON-BSC STENT WERE IMPLANTED. BOTH STENTS BROKE SOMETIME BETWEEN THEN AND 2015. THE PATIENT UNDERWENT ANOTHER EMERGENCY SURGERY FOR ARTERIAL TRANSPLANT AND GRAFT. THAT PROCEDURE FAILED LAST YEAR AND THE PATIENT HAD A LEG AMPUTATION IN 2017.

  Patient problems: No Code Available

  MAUDE report 8370559 ↗
• MalfunctionDec 17, 2018Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED STENT DAMAGE OCCURRED. A 7.0X60X75CM EXPRESS LD ILIAC / BILIARY WAS SELECTED FOR USE IN THE RIGHT COMMON ILIAC. THE DEVICE WOULD NOT CROSS THE LESION. WHEN THE DEVICE WAS ATTEMPTED TO BE REMOVED, IT WOULD NOT COME OFF THE SHEATH BUT THROUGH THE SHEATH. UPON REMOVAL, DAMAGE WAS OBSERVED ON THE EDGE OF THE STENT. ANOTHER OF THE SAME DEVICE ALONG WITH A LONGER SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8170238 ↗
• MalfunctionMar 7, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT BALLOON SEPARATION OCCURRED. A 7.0X60X75CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT A LESION. HOWEVER, WHILE INSIDE THE SHEATH, THE BALLOON MATERIAL CAME OFF THE SHAFT OF THE CATHETER AND IT DETACHED COMPLETELY OFF THE SYSTEM. THE DEVICE WAS RETRIEVED WITHOUT PROBLEMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO SEQUELAE WITH THE PATIENT AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321306 ↗