VICI VENOUS STENT ® SYSTEM H74916090100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00852725008164), received between Nov 15, 2019 and Mar 4, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

• MalfunctionMar 4, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE DEVICE. A 16MM X 90MM X 100CM VICI STENT SYSTEM WAS SELECTED FOR USE IN AN ILIAC VEIN STENTING PROCEDURE. DURING PREPARATION, THE STENT WAS FLUSHED, AND BLUE LINT-LIKE PARTICLES WERE CONTINUOUSLY FLUSHED OUT OF IT. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT HAD A GOOD OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11409002 ↗
• InjurySep 22, 2020Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED VIA VOLUNTARY MEDWATCH MW5096067. A 16X90MM VICI SELF-EXPANDING STENT WAS IMPLANTED IN THE LEFT COMMON AND EXTERNAL ILIAC VEIN ON (B)(6) 2019. IN 2020, THE PATIENT PRESENTED WITH PROGRESSIVE DYSPNEA ON EXERTION AND IMAGING FOUND A MIGRATED STENT IN THE RIGHT ATRIUM ASSOCIATED A PERICARDIAL EFFUSION. SURGERY WAS PERFORMED, BUT ONLY 9CM OF THE VICI STENT WAS ABLE TO BE REMOVED. THE REMAINING STENT WAS STUCK WITHIN THE INFERIOR VENA CAVA (IVC) WALL. LATER IN 2020, THE PATIENT AGAIN PRESENTED WITH WORSENING DYSPNEA ON EXERTION AND A PERICARDIAL TAMPONADE REQUIRING PERICARDIOCENTESIS WAS FOUND. THE PATIENT HAS EFFUSIVE-CONSTRICTIVE PERICARDITIS AS A RESULT OF THESE PROCEDURES.

  Patient problems: Cardiac Tamponade; Device Embedded In Tissue or Plaque; Dyspnea; Pericardial Effusion

  MAUDE report 10570015 ↗
• InjuryNov 15, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO PLACE AND IT MOVED REQUIRING ADDITIONAL INTERVENTION. A 60X90X100 VICI SELF EXPANDING STENT WAS SELECTED FOR AN ILIAC VENOUS STENTING PROCEDURE IN THE LEFT SIDE COMMON ILIAC VEIN (CIV) PROXIMAL. THE LESION WAS 50MM IN THE REFERENCE VEIN MEASURING 14.75MM DISTAL AND 15.5MM PROXIMAL. ACCESS WAS OBTAINED THROUGH THE LEFT COMMON FEMORAL VEIN (LCFV). DEPLOYMENT WAS INITIATED, BUT THE STENT WAS REPOSITIONED TO DEPLOY AT THE BIFURCATION. THE STENT WAS PRECISELY PLACED RIGHT AT THE BIFURCATION AND COVERED THE COMPRESSION. THE STENT WAS INTERROGATED UNDER IVUS AND IT WAS FOUND TO NOT BE PROVIDING THE OUTWARD RADIAL FORCE NECESSARY TO IMPROVE OUTFLOW. THE STENT UNDER FLUOROSCOPY SHOWED A SHIFT DOWNWARD ABOUT 1.5-2CM BACK INTO THE LCIV, BELOW THE COMPRESSION. THIS WAS NOT WHERE THE PHYSICIAN INTENDED TO RELEASE THE STENT. DEPLOYMENT WAS DIFFICULT DUE TO THE DELIVERY SYSTEM. IT WAS DIFFICULT TO SLIDE TO RELEASE THE STENT. POST DILATATION WAS DONE WITH A 16MMX4MM BALLOON AT 5ATM. A SECONDARY STENT WAS PLACED TO IMPROVE THE LANDING ZONE OUTFLOW AS WELL AS TO PROVIDE OPTIMAL RADIAL STRENGTH. THE STENT WAS IMPLANTED WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9328302 ↗

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.