VICI VENOUS STENT ® SYSTEM H74914120100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00852725008140), received between Feb 4, 2021 and May 12, 2021 — classified as 3 injuries.

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

• InjuryMay 12, 2021Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. A 4MMX120MMX100CM VICI SELF-EXPANDING STENT WAS SELECTED FOR TO TREAT VENOUS COMPRESSION (NIVL). THE STENT WAS PLACED IN THE PROXIMAL COMMON ILIAC VEIN (CIV) TO THE MID-EXTERNAL ILIAC VEIN (EIV) ON (B)(6) 2021. PRIOR TO IMPLANT, IMAGING WAS PERFORMED VIA IVUS AND VENOGRAM AND THE STENT WAS SELECTED BASED ON THE MEASUREMENTS GATHERED. POST IMPLANT, THE STENT WAS BALLOONED AND IT WAS REPORTED TO BE FULLY EXPANDED AND APPOSED TO THE VESSEL WALLS. WHEN PATIENT RETURNED TO THE HEALTH CARE FACILITY ON (B)(6) 2021 FOR AN ADDITIONAL PROCEDURE, IT WAS NOTED THAT THE STENT HAD MIGRATED TO THE INFERIOR VENA CAVA (IVC). THE STENT WAS NOT REPOSITIONED OR REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813171 ↗
• InjuryApr 23, 2021Positioning Problem; Migration; Positioning Problem; Migration

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO POSITION AND STENT MIGRATION OCCURRED. A 14X120MM, 100CM AND A 16X60MM, 100CM VICI STENT SYSTEM WERE SELECTED FOR USE IN A PROCEDURE ON (B)(6) 2021. THE PATIENT PRESENTED WITH COMPRESSION OF THE LEFT COMMON ILIAC VEIN (LCIV) AND STENOSIS OF THE LEFT EXTERNAL ILIAC VEIN (LEIV) UPON OBTAINING INTRAVASCULAR ULTRASOUND (IVUS) IMAGES. THE REFERENCE EXTERNAL ILIAC VEIN (EIV) AVERAGED 13MM. THE EIV WAS MEASURED BECAUSE THERE WAS NOT A PLACE WITHIN THE CONFLUENCE THAT WAS ABLE TO BE MEASURED. A 14X120MM VICI STENT WAS PLACED FROM THE COMMON ILIAC VEIN (CIV) TO THE DISTAL EIV. UPON DEPLOYMENT, THE STENT DROPPED BELOW THE CIV COMPRESSION DUE TO THE SEVERITY OF THE COMPRESSION. ONLY 2CM OF THE STENT WAS IN THE CONFLUENCE. A 16X60MM VICI STENT WAS PLACED ABOVE THE 14X120MM STENT WITH APPROXIMATELY A 2-3CM OVERLAP INTO THE 14X120MM STENT. THE STENTS WERE POST-DILATED WITH A BALLOON. IVUS IMAGES WERE OBTAINED SHOWING COMPLETE APPOSITION TO THE VEIN WALLS. ON (B)(6) 2021, THE PATIENT WENT TO THE EMERGENCY DEPARTMENT WITH HEART FLUTTERING AND SHORTNESS OF BREATH. IMAGES WERE OBTAINED THAT SHOWED BOTH VICI STENTS HAD MIGRATED TO THE RIGHT ATRIUM AS A

  Patient problems: Dyspnea; Unspecified Heart Problem

  MAUDE report 11717044 ↗
• InjuryFeb 4, 2021Migration; Migration

  IT WAS REPORTED THAT THE STENTS MIGRATED. ON (B)(6) 2019, A 14MM X 90MM X 100CM AND A 14MM X 120MM X 100CM VICI SELF-EXPANDING STENTS WERE IMPLANTED IN THE BILATERAL ILIAC VEIN FOR TREATMENT OF MAY-THURNER SYNDROME AT THE OSTEUM. THE STENTS WERE KISSING AT THE INFERIOR VENA CAVA. THE 120MM STENT WAS PLACED WITHIN THE TARGET LESION, AND BOTH STENTS COVERED WELL. ON (B)(6) 2021, THE PATIENT PRESENTED WITH SYMPTOMS REPRESENTATIVE OF DEEP VENOUS DISEASE, WHICH INCLUDED ULCERATIONS, EDEMA, AND A LACK OF RELIEF FROM THE ORIGINAL SYMPTOMS AFTER THE FIRST PROCEDURE. UPON DOING A FOLLOW-UP VENOGRAM, THE STENTS PRESENTED SIDE-BY-SIDE IN THE MID UPPER VENA CAVA, WHICH WAS HIGHER THAN THE CONFLUENCE. IT WAS UNCLEAR IF THE STENTS MIGRATED PERI-OPERATIVELY DURING THE PREVIOUS INTERVENTION ON (B)(6) 2019, OR IF THEY MIGRATED POST OPERATIVELY. THE STENTS WERE STABLE. THE PROCEDURE WAS RESOLVED BY PLACING TWO NON-OVERLAPPING SELF-EXPANDING WALLSTENTS IN THE ILIAC. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Swelling/ Edema; Ulcer

  MAUDE report 11279400 ↗

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-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.
• 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.