GORE VIABAHN Endoprosthesis VBCR071501ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132623471), received between Dec 28, 2023 and Dec 28, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryDec 28, 2023Difficult to Remove; Difficult to Remove

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE FOREARM DURING TREATMENT OF VENOUS OUTFLOW STENOSIS. DURING THE ADVANCEMENT OF THE VSX DEVICE THOUGH AN 8FR MERIT INTRODUCER SHEATH OVER A 0.053" MERIT GUIDE WIRE, THE VSX DEVICE HAD BECOME STUCK APPROXIMATELY HALFWAY INTO THE VESSEL AND THE INTRODUCER SHEATH. WITH NO DEVICE EXPANSION THE PHYSICIAN WAS UNABLE TO RETRACT THE VSX DEVICE BACK THROUGH THE INTRODUCER SHEATH. THE PHYSICIAN MADE THE DECISION TO PERFORM A SURGICAL REMOVAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18412759 ↗