Viance™ VNC-SD-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684073759), received between Jun 27, 2018 and Jun 27, 2018 — classified as 1 death.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IN THIS INCIDENT HAD A TOTAL RIGHT PROXIMAL TO MID ILIAC OCCLUSION THAT WAS APPROACHED RETROGRADE ON THE RIGHT SIDE. THE VESSEL WAS PRE-DILATED. THE TARGET LESION WAS A CTO (CHRONIC TOTAL OCCLUSION-100%) WITH SEVERE CALCIFICATION. THE VESSEL WAS MODERATELY TORTUOUS. A VIANCE CATHETER WAS INITIALLY USED TO TRY AND CROSS THE LESION BUT WENT SUB-INTIMAL AND POTENTIALLY OUTSIDE THE VESSEL IN THIS ATTEMPT BELOW THE OCCLUSION. A GUIDE WIRE AND RE-ENTRY CATHETER WERE USED SUCCESSFULLY TO EVENTUALLY NAVIGATE PAST THE LESION AND RE-ENTER THE ILIAC. TREATMENT TO THE PROXIMAL RIGHT ILIAC THEN WAS ORIGINALLY APPROACHED WITH THE THOUGHT IN MIND OF USING A PROTÉGÉ GPS ON THE OSTIAL AND PROXIMAL ILIAC WITH THE GOAL OF NOT COMPROMISING OR JAILING THE INTERNAL ILIAC. A 10X80 PROTÉGÉ GPS WAS DEPLOYED SUCCESSFULLY. AN EVERFLEX 8X80 WAS USED TO TREAT A STENOSIS ON THE LEFT ILIAC SUCCESSFULLY AS WELL. IT WAS THEN NOTED THE PATIENT¿S BLADDER LOOKED COMPRESSED, A TYPICAL SIGN OF AN INTERNAL BLEEDING SITUATION. A NON-MDT COVERED STENT WAS PLACED DISTAL TO THE 10X 80 PROTÉGÉ IN THE RIGHT ILIAC WHERE THE BLEED APPEARED TO BE AND THIS SEEMED TO RESOLVE THE ISSUE. UPON FURTHER EXAMINATION OF THE P

  Patient problems: Death; Perforation

  MAUDE report 7640842 ↗