VICI VENOUS STENT ® SYSTEM H74914060100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00852725008126), received between Aug 28, 2020 and Nov 3, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2022Migration; Migration

  IT WAS REPORTED THAT THE STENTS MIGRATED AND REQUIRED EXPLANT. ON (B)(6) 2020, A 14X60 VICI STENT WAS IMPLANTED IN THE RIGHT COMMON ILIAC VEIN. THE PATIENT PRESENTED WITH RIGHT COMMON ILIAC AND EXTERNAL ILIAC VEIN COMPRESSION. IVUS IMAGING WAS OBTAINED ALONG WITH MEASUREMENTS, AND A PRE-DILATION OF THE COMMON ILIAC AND EXTERNAL ILIAC WAS PERFORMED WITH A 14X60 AND A 16X60 XXL BALLOON. AN ADDITIONAL IVUS RUN WAS RECORDED, AND IT WAS NOTED THAT THERE WAS RECOIL. THE DECISION WAS MADE TO PLACE A 14X60 VICI STENT IN THE RIGHT COMMON ILIAC VEIN. THERE WAS STILL COMPRESSION IN THE EXTERNAL ILIAC VEIN, SO AN ADDITIONAL STENT (16X60 VENOUS WALLSTENT) WAS PLACED IN THE EXTERNAL ILIAC VEIN. POST DILATION OF THE STENTS WAS PERFORMED. A FOLLOW UP INTRAVASCULAR ULTRASOUND EXAM REVEALED SIGNIFICANT IMPROVEMENT WITH AN INCREASE IN CROSS-SECTIONAL AREA. A VENOGRAM WAS ALSO PERFORMED, AND THE PHYSICIAN COMPLETED THE PROCEDURE. PATIENT TOLERATED THE PROCEDURE WELL AND RECOVERED WITH NO COMPLICATIONS. 6-MONTH FOLLOW UPS WERE PERFORMED WITH ULTRASOUND, AND THE STENTS WERE INTACT. SOMETIME IN THE TWO WEEKS PRIOR TO (B)(6) 2022, THE PATIENT PRESENTED WITH HEART PALPITATIONS. BOTH THE VICI AND VENOUS WAL

  Patient problems: Atrial Fibrillation; Unspecified Heart Problem

  MAUDE report 15720713 ↗
• InjuryApr 23, 2021Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. A 14X60MM, 100CM VICI STENT SYSTEM WAS SELECTED FOR USE. FOLLOWING PRE-DILATION, THE VICI STENT WAS DEPLOYED IN THE PROXIMAL LEFT ILIAC VEIN. UNDER FLUOROSCOPY, A BALLOON WAS INSERTED FOR POST-DILATION. HOWEVER, IT WAS NOTICED THAT THE STENT HAD MIGRATED TO THE INFERIOR VENA CAVA (IVC). WHEN ATTEMPTING TO INSERT THE BALLOON FURTHER, THE STENT THEN MIGRATED FURTHER UP THE IVC UNTIL IT REACHED THE RIGHT ATRIUM OF THE HEART. A SNARE WAS USED TO RETRIEVE THE STENT AND REMOVE IT FROM THE PATIENT. A NEW VICI STENT OF THE SAME SIZE WAS THEN DEPLOYED IN THE TARGET LESION WITH NO DIFFICULTIES. THE PROCEDURE WAS COMPLETED AND THE PATIENT DID WELL. 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 11717211 ↗
• InjuryMar 2, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT AND VENOUS TISSUE DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH MAY-THURNER COMPRESSION. THERE WAS COMPRESSION IN THE COMMON ILIAC AND THERE WAS CHRONIC DEEP VEIN THROMBOSIS IN THE ILIAC SYSTEM. IT WAS ALSO NOTED THAT THERE WERE A LOT OF PARA-VENOUS FIBROSIS THROUGH BOTH EXTERNAL AND COMMON ILIAC. THE TARGET LESION WAS PRE-DILATED WITH A 12MM BALLOON CATHETER. THE LESION QUICKLY CLOSED DUE TO THE COMPRESSION WITHIN THE ILIAC. A 14X60MM, 100CM VICI SELF EXPANDING STENT WAS ADVANCED AND DEPLOYED. THE PROXIMAL END OF THE STENT REMAINED CRIMPED TO THE DELIVERY SYSTEM AND THE STENT DID NOT FULLY DEPLOY FROM THE DELIVERY SYSTEM. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE LESION BY TURNING IT ON ITSELF AND PULLING IT BACK THROUGH THE VESSEL AND THROUGH THE SHEATH. ONCE THE STENT WAS REMOVED FROM THE PATIENT THE STENT WAS INSPECTED. THERE APPEARED TO BE FIBROUS TISSUE AROUND THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER STENT OF A DIFFERENT SIZE. IMAGING WAS PERFORMED AND THERE WAS NO DAMAGE NOTED TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11401718 ↗
• InjuryAug 28, 2020Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED AND ADDITIONAL INTERVENTION WAS REQUIRED. A 14X60X100 VICI SELF-EXPANDING STENT WAS SELECTED FOR MAY-THURNER TREATMENT PROCEDURE IN THE LEFT COMMON ILIAC VEIN. DURING THE PROCEDURE, THE STENT WAS IMPLANTED WITH NO COMPLICATIONS. AFTER TWO MINUTES OF DEPLOYMENT, ANOTHER ANGIOGRAM WAS TAKEN AND THE STENT DISTAL ENDS DID NOT SEAT WELL WITHIN MAY-THURNERS SEGMENT OF VEIN. THE STENT MIGRATED HIGHER WITHIN THE VENOUS SYSTEM AND WAS NO LONGER IN THE PROPER LOCATION TO APPEASE THE INITIAL STENOSIS AND COMPRESSION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER 14X60 VICI SELF-EXPANDING STENT TO EXTEND THE PREVIOUS DISPLACED STENT WHICH OVERLAPPED DISTALLY TO THE MIGRATED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS ASYMPTOTIC AND FINE POST PROCEDURE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10465744 ↗

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.