Express® LD Iliac / Biliary H74938047730130Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729579694), received between Jan 17, 2017 and Jun 2, 2023 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON THE BALLOON. DURING PREPARATION, WHEN A 7.0X30X135CM EXPRESS LD ILIAC / BILIARY STENT WAS TAKEN OUT OF THE PACKAGE, IT WAS NOTED THAT THE STENT WAS LOOSE ON THE BALLOON. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054354 ↗
• InjuryApr 25, 2023Material Rupture; Failure to Advance; Device Dislodged or Dislocated; Material Rupture; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MID COMMON ILIAC VEIN. A 7.0X30X135CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE TRYING TO CROSS THE TIGHT, AND CALCIFIC AORTIC LESION, THE STENT DISLODGED IN THE PROXIMAL LEFT COMMON ILIAC VEIN. WHEN THE PHYSICIAN INFLATED THE STENT BALLOON TO SECURE THE STENT, THE BALLOON RUPTURED AT AROUND 8-12 ATMOSPHERES. IT WAS NOTED THAT THE STENT WAS SUCCESSFULLY OPPOSE TO THE VESSEL WHERE IT WAS DISMOUNTED. THE CONTRAST WAS USED TO TAKE AN ANGIOGRAM TO ENSURE PLACEMENT, FOLLOWED BY SUCCESSFULLY PLACING ANOTHER EXPRESS LD STENT IN THE INTENDED LOCATION WITH NO ISSUES. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812332 ↗
• MalfunctionJan 5, 2023Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 7.0X30X135CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS CAUGHT ON THE SHEATH AND THE STENT WAS DEFECTIVE. SUBSEQUENTLY, ANOTHER 7.0X30X135CM EXPRESS LD STENT WAS ADVANCED. THE SECOND DEVICE WAS ALSO CAUGHT ON THE SHEATH AND DEFECTIVE. BOTH DEVICES WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109468 ↗
• MalfunctionJan 5, 2023Device Damaged by Another Device; Device-Device Incompatibility; Material Deformation; Device Damaged by Another Device; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 7.0X30X135CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS CAUGHT ON THE SHEATH AND THE STENT WAS DEFECTIVE. SUBSEQUENTLY, ANOTHER 7.0X30X135CM EXPRESS LD STENT WAS ADVANCED BUT THE DEVICE WAS ALSO CAUGHT ON THE SHEATH AND WAS ALSO DEFECTIVE. BOTH DEVICES WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109340 ↗
• MalfunctionJun 1, 2022Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10-MAY 2022. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT SUBCLAVIAN ARTERY. A 7.0X30X135CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING INTRODUCTION, IT WAS FOUND THAT THE 7FR INTRODUCER SHEATH WAS FOLDED AND THE SHAFT WAS KINKED AFTER PASSING THROUGH THE KNOB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14568472 ↗
• InjuryMay 5, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH ILIAC STENOSIS. THE >90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC ARTERY. A 7.0 X 30 X 135CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. BUT THE STENT FAILED TO CROSS THE LESION. UPON REMOVAL THE STENT BECAME DISLODGED AS IT WAS HUNG IN PART OF THE LESION. THE BALLOON DELIVERY SYSTEM WAS REMOVED, AND A SMALLER IN SIZE STERLING BALLOON CATHETER WAS INSERTED OVER THE .018 NON-BOSTON SCIENTIFIC GUIDEWIRE. THE STERLING WAS UTILIZED TO INFLATE INSIDE THE UNDEPLOYED STENT WHICH DEPLOYED IT PROPERLY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287998 ↗
• MalfunctionJan 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY. A 7.0X30X135CM EXPRESS LD ILIAC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE PHYSICIAN FELT THAT THE STENT WAS MOVING ON THE BALLOON UPON ADVANCING THE STENT SYSTEM. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13210735 ↗
• MalfunctionJul 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS BUT SEVERELY CALCIFIED LEFT SUBCLAVIAN VESSEL. A 7.0X30X135CM EXPRESS LD ILIAC/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT CAME OFF AND IT WAS REMOVED THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235984 ↗
• InjuryMay 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED VIA ATTACHED MEDWATCH MW5100114. THE TARGET LESION WAS LOCATED IN THE MESENTERIC ARTERY. A 7.0X30X135CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT BROKE OFF THE BALLOON AND TRAVELED INTO THE AORTA AND LANDED IN THE OCCLUDED LEFT ILIAC VESSEL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11777875 ↗
• InjuryMar 1, 2021Material Rupture; Activation Failure; Migration; Material Rupture; Activation Failure; Migration

  IT WAS REPORTED THAT BALLOON RUPTURE, INSUFFICIENT STENT APPOSTION AND STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT OSTIAL CAROTID ARTERY. A 7.0X30X135CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN DEPLOYING THE STENT THE BALLOON RUPTURED. THE STENT WAS INSUFFICIENTLY APPOSED AND SHAPED LIKE A DOG BONE. UPON REMOVAL OF THE BALLOON, THE STENT SLID AT ABOUT 1 CM INTO THE AORTA. THE PHYSICIAN USED A BALLOON CATHETER IN AN ATTEMPT TO POSITION THE STENT DEEPER INSIDE THE CAROTID AND OUT OF THE AORTA BUT THE THE STENT WOULD NOT ADVANCE. THE STENT IS PLACED INTO THE OSTIUM AND IS PROTRUDING 1 CM INTO THE AORTA. THE STENT IS COVERING THE LESION AND SUCCESSFULLY RESTORED FLOW TO 100%. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS REPORTED. THE PATIENT WAS FINE AND WAS DISCHARGED. IT WAS FURTHER REPORTED THAT THE 60-65% STENOSED TARGET LESION WAS TORTUOUS AND AND CALCIFIED. THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 2-3 ATMOSPHERES. IT WAS FURTHER REPORTED THAT THE STENT WAS PULLED INTO THE AORTA WHEN THE BALLOON WAS REMOVED AND THAT IT WAS THE LESION THAT HELD THE STENT INTO PLACE PREVENTING IT FROM FALLING COMPLETELY OUT OF THE OSTIUM OF

  Patient problems: Embolism/Embolus; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11394639 ↗
• InjuryJun 11, 2020Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT BALLOON RUPTURE AND SERIOUS DAMAGE TO THE VESSEL OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC ARTERY. A 7.0X30X135CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. THE FRONT SIDE OF THE DEVICE WAS DEPLOYED AND ATTACHED TO THE VESSEL; HOWEVER, WHEN THE BALLOON WAS INFLATED AT 2 ATMOSPHERES, THE BALLOON RUPTURED. DURING REMOVAL OF THE DEVICE, IT WAS NOTICED THAT THE VESSEL WAS SERIOUSLY DAMAGED. THE PHYSICIAN USED A SNARE WIRE TO RETRIEVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 10143942 ↗
• InjuryJan 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT EXTERNAL ILIAC ARTERY. A 7.0X30X135CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. IT WAS NOTED TO BE THE WRONG LENGTH STENT. THE STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE STENT CAME OFF THE BALLOON. A SMALLER BALLOON WAS THEN USED TO DILATE THE DISLODGED STENT AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS NON-TORTUOUS AND MODERATELY CALCIFIED. THE STENT FELL OFF THE BALLOON WHILE TRYING TO RETRIEVE THE UNDEPLOYED SYSTEM FROM THE BODY AND THE STENT WAS DEPLOYED WHERE IT LODGED. ADDITIONAL STENTING WAS DONE TO TREAT THE TARGET LESION AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591757 ↗
• InjuryOct 17, 2018Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 7.0X30X135CM EXPRESS LD ILIAC / BILIARY WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 8 ATMOSPHERES THE BALLOON RUPTURED DURING INITIAL INFLATION. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT AS THE STENT WAS NOT COMPLETELY DEPLOYED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7974499 ↗
• InjuryFeb 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT GROIN. THE IN-STENT RESTENOSED TARGET LESION WAS LOCATED IN THE LEFT ILIAC ARTERY . A 7.0X30X135CM EXPRESS® LD ILIAC/BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF OF THE STENT DELIVERY BALLOON. THE DISLODGED STENT WAS CRUSHED AGAINST THE VESSEL WALL AND ANOTHER WAS IMPLANTED. THE PROCEDURE WAS THEN COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6329029 ↗
• InjuryJan 17, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUBCLAVIAN ARTERY. A 7.0X30X135CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING ADVANCEMENT, THE STENT CAME OFF THE BALLOON. THE DEVICE WAS PULLED OUT AND THE STENT WAS REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6256010 ↗