VICI VENOUS STENT ® SYSTEM H74916120100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00852725008171), received between Jul 10, 2019 and Feb 23, 2022 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2022Fracture; Fracture

  IT WAS REPORTED VIA VOLUNTARY MEDWATCH/ MAUDE REPORT LIST # MW5106402 THAT THE STENT OCCLUDED AND FRACTURED. IN 2020, A 16MM X 120MM, 100CM VICI STENT WAS IMPLANTED IN THE LEFT EXTERNAL ILIAC. IN 2021, A VENOGRAM REVEALED THAT THE STENT OCCLUDED. THROMBECTOMY WAS PERFORMED TO TREAT THE OCCLUSION. A STENT FRACTURE WAS OBSERVED, AND A NON-BOSTON SCIENTIFIC STENT WAS IMPLANTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13586341 ↗
• InjuryFeb 11, 2021Migration; Migration

  IT WAS REPORTED THAT THE STENT MIGRATED. A 16X120MM, 100CM VICI WAS SELECTED FOR USE. THE PATIENT HAD SIGNIFICANT COMPRESSION BILATERALLY, AND IT WAS PLANNED TO TREAT BILATERALLY. DURING THE ENTIRE PROCEDURE, THE PATIENT WAS NOTED TO BE NON-COMPLIANT AND WAS CONTINUOUSLY MOVING, WHICH CAUSED DIFFICULTY. THERE WERE TWO VENOUS ACCESS POINTS AT THE GROIN. A VENOGRAM WAS PERFORMED, AND INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO HELP SIZE THE STENT. MEASUREMENTS WERE PERFORMED, WHICH INDICATED THAT A 16X120MM VICI STENT WAS APPROPRIATE. THE COMPRESSION AREA WAS APPROXIMATELY 68MM SQUARED: 7.1MM X 11.5MM AT THE MIN AND MAX DIAMETERS. THE COMPRESSED LESION AREA WAS 8MM. THE REFERENCE VEIN DIAMETER CENTRAL TO THE COMPRESSION WAS APPROXIMATELY 170MM SQUARED: 10.6MM X 20.4MM AT THE MIN AND MAX DIAMETERS. THE HEALTHY PORTION OF THE VEIN WAS APPROXIMATELY 15MM AVERAGE DIAMETER. THE REFERENCE VEIN DIAMETER PROXIMAL TO THE COMPRESSION WAS APPROXIMATELY 146MM SQUARED: 10MM X 14MM AT THE MIN AND MAX DIAMETERS. THE STENT WAS DEPLOYED SUCCESSFULLY AND PLACED AS INTENDED. IMMEDIATELY AFTER DEPLOYMENT, THE PATIENT MOVED AND BORE DOWN. THE WIRE MOVED BACK. POST-BALLOONING HAD NOT YET BEEN PERFORMED. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11315397 ↗
• MalfunctionFeb 2, 2021Positioning Failure; Entrapment of Device; Positioning Failure; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE WAS STUCK ON THE GUIDEWIRE. A 16X120MM, 100CM VICI SELF EXPANDING STENT WAS SELECTED FOR USE IN A STENTING PROCEDURE WITHIN THE LEFT ILIOFEMORAL VEINS. THE PATIENT HAD A TUMOR THAT WAS CAUSING COMPRESSION. DURING THE PROCEDURE, THE STENT WOULD NOT DEPLOY. THE TUOHY WAS LOOSENED TO DEPLOY THE VICI STENT, BUT THE VICI STENT CATHETER WOULD NOT MOVE. THE VICI STENT CATHETER WAS STUCK AND COULD NOT BE PULLED BACK. THE VICI STENT CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A 14X120MM, 100CM VICI SELF EXPANDING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267029 ↗
• MalfunctionDec 14, 2020Activation Failure; Activation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11DEC2020. IT WAS REPORTED THE STENT FAILED TO DEPLOY. A 16MMX120MM, 100CM VICI WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED AND DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11003746 ↗
• InjuryNov 5, 2020Migration; Migration

  IT WAS REPORTED THAT THE STENT MOVED WITHIN THE PATIENT'S ANATOMY. A 16X120X100 VICI SELF-EXPANDING STENT WAS SELECTED FOR TREATMENT OF A MAY THURNER LESION IN THE COMMON ILIAC VEIN (CIV). THE STENT WAS SUCCESSFULLY DEPLOYED AND APPEARED FULLY APPOSED. UPON REMOVAL OF THE DEPLOYMENT SYSTEM, THE STENT MOVED APPROXIMATELY 100MM WITHIN THE PATIENT'S VESSEL INTO THE MID-IVC (INFERIOR VENA CAVA) AND PROXIMAL COMMON ILIAC VEIN, LEAVING THE DISTAL TIP IN THE CIV. THIS EVENT REQUIRED THE PLACEMENT OF TWO ADDITIONAL STENTS, 18X90 WALLSTENTS, TO COVER THE INTENDED LOCATION. NO PATIENT COMPLICATIONS WERE REPORTED, BUT THE VICI REMAINED WITHIN THE PATIENT. THE PATIENT FULLY RECOVERED AND WAS SENT HOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791106 ↗
• MalfunctionOct 20, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED. A 16 X 120MM X 100CM VICI SELF-EXPANDING STENT WAS SELECTED FOR USE. THE LESION WAS 90% STENOSED AND TORTUOSITY WAS NORMAL. DURING DEPLOYMENT OF THE STENT, EXTREME RESISTANCE WAS FELT. AFTER 2-3MM OF THE STENT WAS DEPLOYED AND THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENT WAS DOING WELL POST-PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10705449 ↗
• MalfunctionMar 13, 2020Difficult to Remove; Activation, Positioning or Separation Problem; Device-Device Incompatibility; Positioning Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Device-Device Incompatibility; Positioning Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND REMOVAL DIFFICULTIES OCCURRED. A 16X120MM,100CM VICI SELF EXPANDING STENT WAS SELECTED FOR USE TO TREAT THE LESION. DURING DEPLOYMENT OF THE STENT, IT BECAME CAUGHT ON A PREVIOUSLY PLACED VICI STENT ON THE RIGHT SIDE NEAR THE CONFLUENCE. THIS PREVENTED THE STENT TO FULLY DEPLOY. ATTEMPTS WERE MADE TO REMOVE THE PARTIALLY DEPLOYED STENT; HOWEVER, THE STENT WAS GETTING CAUGHT ON ANOTHER PLACED STENT. EVENTUALLY THE PHYSICIAN WAS ABLE TO REMOVE THE STENT AND THE PROCEDURE WAS COMPLETED WITH A NEW STENT OF A DIFFERENT SIZE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9830031 ↗
• 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 9413336 ↗
• MalfunctionJul 10, 2019Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED THAT THE HYPOTUBE BROKE. A 16X120MM, 100CM VICI STENT WAS SELECTED TO TREAT A LESION IN THE RIGHT EXTERNAL ILIAC COMMON FEMORAL VEIN. A 9F SHEATH WAS PLACED AND A 0.035 GUIDEWIRE WAS ADVANCED TO THE LESION. THEN THE VICI STENT WAS INTRODUCED AND DEPLOYMENT WAS INITIATED. THE TUOHY WAS LOOSENED AND THE PHYSICIAN PINNED THE INNER SHAFT AND STARTED TO PULL THE OUTER SHAFT OF THE DELIVERY CATHETER TO START STENT DEPLOYMENT; HOWEVER THE STENT WOULD NOT DEPLOY. THE DEVICE WAS REMOVED FROM THE BODY. IT WAS THEN NOTED THAT THE METAL HYPOTUBE WAS BENT THEN IT BROKE IN HALF. THE PHYSICIAN OPENED A NEW VICI STENT ON THE SAME SIZE AND WAS ABLE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8776146 ↗

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.