Express® SD Renal/Biliary H74937911715900Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729390442), received between Jun 15, 2020 and Jun 1, 2022 — classified as 3 malfunctions.

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

• MalfunctionJun 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH CLAUDICATION. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RENAL ARTERY. A 7.0MM X 15MM X 90CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT WAS CRUSHED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SD STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14558566 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC VEIN. A 6.0MMX14MMX90CM EXPRESS SD STENT WAS ADVANCED BUT THE SHAFT BROKE AND LOST PUSH ABILITY. DURING REMOVAL, THE STENT CAME OFF THE CATHETER. THE PHYSICIAN THEN USED AN OPTICROSS 18 INTRAVASCULAR ULTRASOUND (IVUS) TO LOOK ON THE STENT BUT THE IVUS GOT STUCK IN THE LESION AND THE SCREEN WENT BLACK. SUBSEQUENTLY, A 7.0MMX15MMX90CM EXPRESS SD STENT WAS USED TO TACK UP THE SMALLER STENT BUT IT ALSO BROKE DURING DEPLOYMENT AND HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SD STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12263574 ↗
• MalfunctionJun 15, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE EXTERNAL ILIAC ARTERY. A 7.0MMX15MMX90CM EXPRESS SD STENT WAS ADVANCED FOR TREATMENT IN A BILATERAL LEG ANGIOPLASTY PROCEDURE. DURING ADVANCEMENT, THE STENT BECAME STUCK ON A PREVIOUSLY IMPLANTED STENT. THE STENT BECAME "MANGLED" AS A RESULT. THE DEVICE WAS REMOVED WITHOUT FURTHER INCIDENT AND WAS REPLACED WITH A DIFFERENT STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10155253 ↗