Valeo® Balloon Expandable Biliary Stent EV10361CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741000973), received between Feb 23, 2017 and Feb 6, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2018Separation Failure; Device Dislodged or Dislocated; Separation Failure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON EXPANDABLE STENT ALLEGEDLY WOULD NOT RELEASE FROM THE BALLOON CATHETER. REPORTEDLY, THE STENT AND DELIVERY SYSTEM WERE REMOVED WITHOUT INCIDENT AND EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7246699 ↗
• InjuryFeb 23, 2017Fracture; Occlusion Within Device; Material Deformation; Fracture; Occlusion Within Device; Material Deformation

  AN ARTICLE IN CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2011 TITLED " EXTENSIVE DISTORTION AND DYSFUNCTION OF AN EDWARDS VALEO LIFESTENT PLACED FOR STENOSIS OF THE SUPERIOR VENA CAVA " WAS REVIEWED. THE PATIENT WITH END-STAGE RENAL DISEASE WHO DEVELOPED CATHETER-ASSOCIATED THROMBOSIS AND SYMPTOMATIC HIGH-GRADE SUPERIOR VENA CAVA (SVC) STENOSIS HAD A BALLOON EXPANDABLE STENT DEPLOYED ACROSS THE AREA OF STENOSIS IN THE SVC. APPROXIMATELY SIX MONTHS POST STENT PLACEMENT, AN ECHOCARDIOGRAM PERFORMED FOR PERIORBITAL EDEMA SHOWED A MEAN ESTIMATED PRESSURE GRADIENT ACROSS THE SVC TO BE 17 -21 MM HG. IMAGING SHOWED RECURRENT SVC STENOSIS AND A FRACTURED STENT WITH IN-STENT STENOSIS. A NEW STENT WAS PLACED INTO THE AREA OF THE EXISTING FRACTURED STENT. IMAGING SHOWED SIGNIFICANT IMPROVEMENT AND REPEAT PRESSURE MEASUREMENTS SHOWED A RESIDUAL GRADIENT OF 3 MM HG.

  Patient problems: Edema; Stenosis

  MAUDE report 6355032 ↗