Express® LD Iliac / Biliary H74938047760130Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729392453), received between Apr 11, 2018 and Jun 1, 2022 — classified as 4 injuries, 6 malfunctions.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2022Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DIFFICULTY REMOVAL AND STENT DISLODGEMENT OCCURRED RESULTING TO A SURGICAL INTERVENTION. THE TARGET LESION WAS LOCATED IN ILIAC ARTERY. A 7.0X60X135 CM EXPRESS LD BILIARY STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, WHEN TRIED TO REMOVE THE DEVICE, THE SHEATH WAS PULLED OUT ACCIDENTALLY AND THE PROCEDURE WAS ABORTED. A WEEK LATER, THE PATIENT WAS BROUGHT BACK TO DEPLOY THE STENT AGAIN BUT UNDER FLUOROSCOPY, IT WAS NOTICED THAT THE UNDEPLOYED STENT HAD COME OFF THE BALLOON AND WAS STILL IN THE PATIENT AT THE GROIN. THE PATIENT WAS THEN SENT TO ANOTHER HOSPITAL FOR SURGICAL REMOVAL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14570024 ↗
• MalfunctionApr 4, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE MORE THAN 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED RIGHT ILIAC ARTERY. ARTERIOGRAM PROCEDURE WAS PERFORMED. THE PHYSICIAN WANTED TO INSERT A 7.0X60X135 CM EXPRESS LD ILIAC / BILIARY STENT; HOWEVER, THE STENT DID NOT ADVANCE OVER THE GUIDEWIRE AND IT WAS NOTICED THAT THE DEVICE WAS KINKED. ANOTHER EXPRESS LD STENT OF THE SAME SIZE WAS USED AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13995621 ↗
• MalfunctionAug 10, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY SEVERE CALCIFIED RIGHT ILIAC ARTERY. A 7.0MM X 60MM X 135 CM EXPRESS LD ILIAC STENT WAS ADVANCED FOR TREATMENT WITHOUT BALLOONING THE LESION SITE. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION EVEN AFTER SEVERAL ATTEMPTS AND HAD TO BE REMOVED. THE LESION WAS DILATED WITH A 5.0 BALLOON CATHETER, AND THEN THE STENT WAS LOADED ON THE WIRE AGAIN. AFTER AN ATTEMPT TO DELIVER, THE STENT APPEARED LOOSE ON ITS BALLOON. THE DEVICE WAS COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED BY BALLOONING THE LESION SITE FIRST AND DEPLOYING ANOTHER EXPRESS LD STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304945 ↗
• MalfunctionAug 10, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 8.0X40X135CM AND A 7.0X60X135CM EXPRESS-B-I LD STENTS WERE ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, BOTH STENTS FAILED TO ADVANCE THROUGH SHEATH. THE PROCEDURE WAS ABORTED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303633 ↗
• MalfunctionAug 6, 2020Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21JUL2020. IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDY CALCIFIED ILIAC ARTERY. A 7.0X60X135 CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING ADVANCING, THE DEVICE WAS STUCK IN THE SHEATH. BOTH DEVICES WERE REMOVED FROM THE PATIENT'S BODY AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10376020 ↗
• InjuryJul 14, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT DEPLOYED DURING ADVANCEMENT. A 7.0X60X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT SLIDE OUT WHEN THE PHYSICIAN TRIED TO APPROACH THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE STENT WAS PREMATURELY DEPLOYED DURING CROSSOVER PROCEDURE AND WAS IMPLANTED IN THE PATIENT'S BODY. IT WAS FURTHER REPORTED THAT THE DEVICE WAS RETRIEVED AND WAS NOT IMPLANTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10272175 ↗
• InjuryFeb 10, 2020Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND SNARING OCCURRED. THE TARGET LESION WAS LOCATED IN THE BIFURCATION OF THE ILIAC ARTERY. A PREVIOUSLY PLACED STENT WAS IMPLANTED IN THE COMMON ILIAC OVER 2 YEARS PRIOR TO THIS PROCEDURE. DURING ADVANCEMENT OF THE 7.0X60X135 CM EXPRESS LD STENT, THE STENT DISLODGED FROM THE BALLOON CATHETER. SUBSEQUENTLY, THE PHYSICIAN HAD TO GAIN ACCESS THROUGH THE LEFT ARTERY TO RETRIEVE THE DISLODGED STENT. UPON ATTEMPTING TO REMOVE THE STENT VIA SNARING, THE STENT GOT CAUGHT IN THE PREVIOUSLY IMPLANTED STENT AND BOTH STENTS WERE REMOVED WITH THE SNARE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9688098 ↗
• MalfunctionSep 24, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT COMMON ILIAC ARTERY. A 7.0 X 60 X 135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED; HOWEVER, RESISTANCE WAS ENCOUNTERED AND IT WOULD NOT ADVANCED TO THE LESION. THE PHYSICIAN PULLED THE STENT OUT AND IT WAS NOTED THAT THE DISAL END OF THE STENT WAS CRIMPED OR RAZED. ANOTHER 7.0 X 60 X 135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9114238 ↗
• MalfunctionOct 25, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PACKAGE WAS DAMAGED. A 7.0X60X135 CM EXPRESS LD STENT WAS SELECTED FOR USE. HOWEVER, UPON OPENING THE PACKAGE, THE WRAPPER WAS NOTED TO BE DAMAGED. THE DEVICE WAS NOT USED IN THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 8005612 ↗
• InjuryApr 11, 2018Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE AND VESSEL PERFORATION OCCURRED, A PATIENT WENT INTO SURGERY. THE TARGET LESION WAS LOCATED IN THE RIGHT EXTERNAL ILIAC ARTERY. A 7.0 X 60 X 135 CM EXPRESS® LD ILIAC / BILIARY STENT WAS DEPLOYED AT 12 ATMOSPHERES TO THE TARGET LESION. HOWEVER, WHEN THE DELIVERY BALLOON WAS ATTEMPTED TO BE REMOVED, THE DEPLOYED STENT FRACTURED IN HALF. THE STENT PERFORATED THE ARTERY AND PATIENT WAS THEN SENT FOR SURGERY TO REMOVE THE FRACTURED STENT. THE PHYSICIAN WAS ABLE TO REMOVE A PART OF THE STENT BUT HAD TO OPERATE AGAIN THE NEXT DAY TO REMOVE THE STENT COMPLETELY. BLOOD FLOW WAS RESTORED TO THE LEG. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE POST-SURGERY.

  Patient problems: Perforation of Vessels

  MAUDE report 7423111 ↗