Express® LD Iliac / Biliary H74938047920130Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729392491), received between May 29, 2019 and Jul 15, 2020 — classified as 2 injuries, 1 malfunction.

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

• InjuryJul 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN A VEIN. A 9.0X30X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE GUIDING CATHETER WAS PULLED, THE STENT BECAME STUCK AND SLID OUT. A WALLSTENT WAS USED TO FIX THE EXPRESS LD ILIAC STENT AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279129 ↗
• InjuryJul 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON ILIAC ARTERY. A 9.0X30X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT BUT THE PHYSICIAN DECIDED NOT TO DEPLOY THE STENT. HOWEVER, AS THE PHYSICIAN TAKING THE STENT OUT OF THE BODY, IT SLID OFF THE BALLOON CATHETER. A 6X20 CHARGER BALLOON CATHETER WAS PLACED TO DEPLOY THE STENT AND THE PROCEDURE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT IMAGES WERE PERFORMED WHILE POSITIONING THE 9.0X30X135 CM EXPRESS LD. THE PHYSICIAN WAS INTENDING TO USE THE STENT TO EXTEND THE 7 X 57 EXPRESS LD TO RIGHT COMMON ILIAC/ DISTAL AORTA. HOWEVER, THE PHYSICIAN DECIDED THE INITIAL STENT (7 X 57 EXPRESS LD) PLACED IN THE RIGHT COMMON ILIAC ARTERY WAS SUFFICIENT, SO DECIDED NOT TO DEPLOY THE ADDITIONAL STENT. WHEN THE 9.0X30X135 CM EXPRESS LD WAS PULLED BACK THROUGH THE 7 X 57 STENT, IT WAS CAUGHT BY STENT STRUTS AND SLID OFF THE DEPLOYMENT BALLOON CATHETER INTO THE RIGHT COMMON ILIAC ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8827038 ↗
• MalfunctionMay 29, 2019Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 9.0X30X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED; HOWEVER, WHILE ADVANCING THROUGH A GUIDE CATHETER, RESISTANCE WAS ENCOUNTERED AND THE STENT DETACHED WITH THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8650299 ↗