VICI VENOUS STENT ® SYSTEM H74912060100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00852725008096), received between Dec 6, 2019 and Dec 6, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (P180013); they may or may not involve this specific model.

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.

• MalfunctionDec 6, 2019Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED. TWO VICI STENTS WERE SELECTED FOR A SUBCLAVIAN VEIN VENOGRAM PROCEDURE TO TREAT STENOSIS SECONDARY TO PACEMAKER LEADS. ACCESS WAS AT THE BIRACIAL VEIN USING A 9F SHORT INTRODUCER SHEATH. PRE-DILATATION WAS PERFORMED. DURING THE PROCEDURE, THE FIRST 12X90 VICI STENT WAS DEPLOYED NORMALLY. THE SECOND STENT, A 12X60X100 VICI STENT, WAS OVERLAPPED WITH THE FIRST. THE DISTAL END OF THE STENT DID NOT DEPLOY, ALTHOUGH THE PROXIMAL END DID. THE NOSE CONE BECAME CAUGHT ON THE EDGE OF THE STENT. WITH SOME MANIPULATION, IT WAS ABLE TO BE REMOVED. THE STENT WAS POST DILATED WITH A BALLOON CATHETER. THE FINAL RESULT WAS GOOD AND THE STENT APPEARED TO BE IN GOOD CONDITION. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9432103 ↗
• InjuryDec 6, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A STENT PARTIAL DEPLOYMENT OCCURRED AND ADDITIONAL INTERVENTION WAS REQUIRED. A 12X60X100 VICI SELF EXPANDING STENT WAS SELECTED FOR USE IN A PREVIOUSLY IMPLANTED RE-STENOSED STENT IN THE SUBCLAVIAN. DURING THE PROCEDURE THE PHYSICIAN HAD BALLOONED THE STENOSIS AND WHEN HE PINNED THE VICI SYSTEM AND PULLED BACK, IT WAS NOTED THE STENT DID NOT FLARE OPEN AS USUAL. THE DISTAL END OF THE STENT MOVED DESPITE THE PROXIMAL END OF THE STENT BEING DEPLOYED AND THE STENT BECAME STUCK. IN AN ATTEMPT TO FULLY DEPLOY THE STENT, THE PHYSICIAN ATTEMPTED TO SNARE THE NOSECONE AND DISCOVERED THAT THE STENT WAS STILL ATTACHED TO THE DEPLOYMENT SYSTEM. THE PHYSICIAN THEN CUT THROUGH THE SHEATH DOWN TO THE WIRE AND PULLED THE NOSECONE OUT THROUGH THE GROIN, AND THE REST OF THE SYSTEM WAS REMOVED THROUGH THE SHEATH IN THE ARM. A BALLOON WAS USED TO OPEN THE CONSTRAINED STENT AND IT OPENED. THE STENT FOLDED BACK ON ITSELF BUT WAS VISUALLY CHECKED WITH AN IVUS CATHETER AND LOOKED ACCEPTABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT SEEMED TO BE DOING FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9430827 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P180013. One submission often covers many models, so check the product and lot details in each record.

• Z-1592-2021 · Apr 12, 2021 · Open, Classified
  VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
• Z-1591-2021 · Apr 12, 2021 · Open, Classified
  VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.