GORE VIATORR TIPS Endoprosthesis PTB8104275Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132635009), received between Feb 18, 2025 and Feb 18, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Stenosis” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Device Stenosis; Device Stenosis

  THE FOLLOWING WAS REPORTED TO GORE: TWO GORE® VIATORR® TIPS ENDOPROSTHESES WITH CONTROLLED EXPANSION WERE IMPLANTED FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE ON (B)(6) 2025. FOR UNKNOWN REASONS, THE PATIENT HAD PRESENTED WITH THROMBOSIS OF THE SUPERIOR MESENTERIC VEIN, PORTAL VEIN, AND SPLENIC VEIN. ON (B)(6) 2025, THE PATIENT UNDERWENT THROMBECTOMY FOR RECURRING SYMPTOMS. FOLLOWING THROMBECTOMY OF THE TWO VIATORR® DEVICES, ANOTHER GORE® VIATORR® TIPS ENDOPROSTHESES WITH CONTROLLED EXPANSION WAS IMPLANTED TO EXTEND TRACT COVERAGE TO THE INTERNAL VENA CAVA. THE CASE WAS COMPLETED SUCCESSFULLY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21404424 ↗