VICI VENOUS STENT ® SYSTEM H74916060100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00852725008157), received between Jun 12, 2019 and Nov 1, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2022Migration; Migration

  IT WAS REPORTED THAT THE STENT MIGRATED. A VICI SELF EXPANDING STENT WAS SELECTED FOR USE TO TREAT MAY-THURNER SYNDROME. ON (B)(6), 2020 THE STENT WAS IMPLANTED IN THE RIGHT ILIAC VEIN. THE IMPLANTED STENT REDUCED THE PREVIOUS SWELLING IN THE RIGHT LOWER EXTREMITY THE PATIENT HAD EXPERIENCED. HOWEVER, THE SWELLING RETURNED AT AN UNSPECIFIED TIME. A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED THAT THE STENT HAD MIGRATED TO THE HEART AND CROSSED THE TRICUSPID VALVE AND WAS PROXIMALLY SITTING IN THE INFERIOR VENA CAVA. THE STENT WAS REMOVED VIA STERNOTOMY ON (B)(6), 2021. THE TRICUSPID VALVE WAS REPAIRED. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6), 2021. THE POST OPERATIVE COURSE WAS NOTED TO BE UNEVENTFUL.

  Patient problems: Swelling/ Edema

  MAUDE report 15711667 ↗
• InjuryApr 23, 2021Migration; Migration

  IT WAS REPORTED THAT A STENT MIGRATION OCCURRED, REQUIRING NEW STENT PLACEMENT. VENOGRAM AND IVUS IMAGING WERE PERFORMED ON AN ACUTE DEEP VEIN THROMBOSIS (DVT), PRIOR TO A STENTING PROCEDURE. THE INFERIOR VENA CAVA (IVC) MEASURED 25MM AND THE LEFT ILIAC MEASURED 15.6-18MM. PRIOR TO STENTING, THROMBECTOMY AND BALLOONING WERE PERFORMED ON THE LESION. A 16 X 60MM X 100CM VICI SELF-EXPANDING STENT WAS SELECTED FOR TREATMENT AND WAS PLACED IN THE LEFT ILIAC/IVC CONFLUENCE. UPON DEPLOYMENT, THE STENT FULLY EXPANDED AND APPOSED THE VEIN WALLS. THE STENT WAS POST-DILATED. THERE WERE NO DIFFICULTIES DURING THE IMPLANT PROCEDURE AND THE PATIENT WAS DISCHARGED. THE PATIENT RETURNED FOR A FOLLOW-UP APPOINTMENT NINE DAYS LATER, WITH DVT. IT WAS FOUND THAT THE STENT MIGRATED DISTALLY, ABOUT 4CM. THE VICI STENT WAS SUCCESSFULLY RE-STENTED WITH A NEW 18 X 90 WALLSTENT ON THE RIGHT AND A 20 X 80 WALLSTENT ON THE LEFT. THE PATIENT IS STABLE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC (BSC) WAS ONLY MADE AWARE OF THIS EVENT FROM THE PHYSICIAN ON APRIL 12, 2021

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720489 ↗
• InjuryApr 23, 2021Migration; Migration

  IT WAS REPORTED THAT 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 UNIT. THE PATIENT WAS STABLE AND AWAITIN

  Patient problems: Dyspnea; Unspecified Heart Problem

  MAUDE report 11717041 ↗
• MalfunctionApr 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHAFT FRACTURE OCCURRED. A 16X60X100 VICI SELF-EXPANDING STENT WAS SELECTED FOR USE TO TREAT A NARROW AND TORTUOUS RENAL VEIN. THE STENT DELIVERY SYSTEM WAS LOADED ONTO A GUIDEWIRE WHILE EXTERNAL TO THE PATIENT. HOWEVER, THE TIP OF THE STENT SHAFT DETACHED. A NEW DEVICE, SAME MODEL, WAS ADVANCED OVER THE GUIDEWIRE AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11622093 ↗
• InjuryOct 26, 2020Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. A 16X60X100 VICI STENT WAS SELECTED FOR TREATMENT OF MAY THURNER SYNDROME, IN A LESION APPROXIMATELY 20MM LONG. INITIAL IMPLANT WAS SUCCESSFUL AND STENT APPEARED FULLY APPOSED IN THE CORRECT LOCATION. POST DILATION WAS PERFORMED AND POST IMAGING APPEARED OK. THE PATIENT MAY HAVE BEEN DEHYDRATED AT THE TIME OF STENT IMPLANT. A WEEK LATER, PATIENT PRESENTED WITH CHEST PAIN AND IT WAS NOTED THAT THE STENT HAD MIGRATED. THE STENT WAS REMOVED SUCCESSFULLY AND PATIENT WAS REPORTED AS DOING FINE POST REMOVAL.

  Patient problems: Chest Pain

  MAUDE report 10733843 ↗
• InjurySep 22, 2020Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. A 16 X 60MM X 100CM VICI SELF-EXPANDING STENT WAS SELECTED FOR USE IN THE RIGHT ILIAC VEIN. A VENOGRAM AND INTRAVASCULAR ULTRASOUND (IVUS) WERE USED TO IMAGE THE LESION PRIOR TO STENT IMPLANTATION. THERE WAS NO SIGNIFICANT LESION OR OBSTRUCTION PRESENT, AND THE PHYSICIAN OPTED TO STENT BASED ON SYMPTOMS ALONE. THE REFERENCE VESSEL WAS 14MM AND THE STENT WAS UPSIZED BY 2 MM. THE STENT WAS IMPLANTED WITHOUT ANY DIFFICULTIES AND A BALLOON WAS USED FOR POST-DILATION. UPON DEPLOYMENT, IVUS WAS PERFORMED SHOWING A WELL APPOSED STENT AND PATENT LUMEN. HOWEVER, ON THE SAME DAY, AFTER THE PATIENT WAS DISCHARGED, THE STENT MIGRATED TO THE HEART. THE PATIENT CONDITION WAS STABLE, AND THE PATIENT RETURNED TO THE HOSPITAL WHERE INTERVENTION WAS PERFORMED. THE STENT WAS RETRIEVED AND REMOVED FROM THE HEART. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED DUE TO SYMPTOMATIC MAY-THURNER ON THE LEFT SIDE. THERE WAS APPROXIMATELY AN 85% FOCAL COMPRESSION ON THE LEFT SIDE. A VICI STENT WAS PLACED WITH NO ISSUES. A 16X60MM STENT WAS ALSO PLACED ON THE RIGHT SIDE BASED ON THE PATIENT SYMPTOMS. THERE WAS NO COMPRESSION AND NO IDENTIFIABLE LESION TO TRE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10569995 ↗
• InjuryJun 12, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT INACCURATE STENT PLACEMENT OCCURRED RESULTING IN ADDITIONAL STENTING. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC VEIN. A 16X60MM VICI STENT WAS SELECTED AND INSERTED VIA A JUGULAR APPROACH. THE DELIVERY SYSTEM WAS ADVANCED WITHIN THE COMMON ILIAC VEIN AND THE PHYSICIAN POSITIONED THE MARKER BANDS ACCORDING TO LESION'S LENGTH. THE STENT WAS DEPLOYED AND THE STENT'S EXPANSION WAS SHORTER THAN THE LENGTH THAT WAS VISUALIZED WHEN SHEATHED IN THE DELIVERY SYSTEM. THE DEPLOYED LENGTH WAS SHORTER BY 3-4MM. THIS RESULTED IN THE LESION NOT BEING FULLY TREATED. SUBSEQUENTLY, ADDITIONAL STENTING WAS REQUIRED USING ANOTHER NON-BSC STENT TO FULLY COVER THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS POST PROCEDURE WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8692395 ↗

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.