VICI VENOUS STENT ® SYSTEM H74914090100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00852725008133), received between Aug 23, 2019 and Feb 4, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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.

• 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 11279389 ↗
• MalfunctionDec 4, 2019Human-Device Interface Problem; Material Integrity Problem; Human-Device Interface Problem; Material Integrity Problem

  IT WAS REPORTED THAT TWO STENTS WERE NOT VISIBLE UNDER FLUOROSCOPY. A 16X120X100 VICI SELF EXPANDING STENT AND A 14X90X100 VICI SELF EXPANDING STENT WERE SELECTED FOR A VENOUS ILIAC STENTING PROCEDURE. THE PATIENT WAS LYING IN THE PRONE POSITION AND THE ACCESS POINT WAS THE LEFT POPLITEAL VEIN. DURING THE PROCEDURE, THE PHYSICIAN WANTED TO LAND THE DISTAL ASPECT OF THE 16X120X100 VICI SELF EXPANDING STENT RIGHT AT THE CONFLUENCE. THE PHYSICIAN BEGAN DEPLOYMENT AND WAS HAVING A DIFFICULT TIME SEEING THE RO MARKER AND COULD NOT SEE THE STENT STRUTS AT ALL. DEPLOYMENT WAS STOPPED AND INSTEAD OF USING FLUOROSCOPY, THE PHYSICIAN USED CINE ACQUISITION TO SEE THE DEVICE BETTER. WHILE USING CINE, IT WAS NOTED THAT THE STENT WAS 50% DEPLOYED IN THE PATIENT'S INFERIOR VENA CAVA (IVC). THE STENT WAS PULLED DOWN TO THE PROPER POSITION AND DEPLOYMENT WAS COMPLETED IN THE LEFT COMMON ILIAC VEIN. A 14X90X100 VICI SELF EXPANDING STENT WAS USED AND THE SAME ISSUES OCCURRED. CINE ACQUISITION WAS USED THROUGHOUT DEPLOYMENT TO MAKE SURE THE STENT WAS PLACED IN THE CORRECT LOCATION. THE STENT WAS PLACED IN THE PATIENT'S LEFT EXTERNAL ILIAC, EXTENDING DOWN INTO THE LEFT COMMON FEMORAL. AFTER BOTH STENTS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9413342 ↗
• MalfunctionAug 23, 2019Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT WAS BEING TREATED FOR MAY THURNER SYNDROME. A 10F SHEATH AND A 14X90X100 VICI SELF EXPANDING STENT WERE SELECTED FOR USE TO TREAT THE LESION. STENT DEPLOYMENT DIFFICULTY WAS ENCOUNTERED AND THE STENT DID NOT DEPLOY INSIDE THE PATIENT. DURING THE REMOVAL OF THE STENT DELIVERY SYSTEM, REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE STENT DELIVERY SYSTEM WAS ABLE TO BE FULLY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC VEIN. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, ADDITIONAL STENT DEPLOYMENT OCCURRED ON THE BACK TABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925002 ↗

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.