GORE VIABAHN Endoprosthesis VBC060502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132614448), received between May 18, 2020 and May 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Activation Problem” (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.

• InjuryMay 18, 2020Migration or Expulsion of Device; Activation Problem; Migration or Expulsion of Device; Activation Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, A PATIENT WAS TO BE IMPLANTED WITH A 6MM X 5CM GORE® VIABAHN® ENDOPROSTHESIS TO TREAT LEFT SUPERFICIAL FEMORAL ARTERY RESTENOSIS. THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A BARE METAL STENT(BMS) IN THE DISTAL OF LEFT SUPERFICIAL FEMORAL ARTERY. NOW THE ORIGINAL STENT WAS BROKEN AND IN STENT RESTENOSIS(ISR) WAS FOUND. THE VIABAHN DEVICE WAS ADVANCED VIA THE SHEATH FROM THE RIGHT FEMORAL ARTERY TO THE TARGET LESION, AND WAS DILATED WITH 5MM BALLOON. THE PHYSICIAN INITIATED AND PULLED OUT THE DEPLOYMENT LINE SUCCESSFULLY. HOWEVER, THE DISTAL OF THE VIABAHN DEVICE COULDN'T EXPAND. THE VIABAHN DEVICE MIGRATED WHEN THE DELIVERY SYSTEM WAS REMOVED. THE SITUATION COULDN'T BE SOLVED AFTER WAITING FOR 5 MINUTES. THE PHYSICIAN TRIED TO ADVANCE ANOTHER 8FR SHEATH VIA THE GUIDEWIRE INTO THE VIABAHN DEVICE, BUT COULDN'T MAKE IT. AFTER THAT THE PHYSICIAN DECIDED TO PERFORM A SURGICAL INTERVENTION FROM LEFT POPLITEAL ARTERY TO REMOVE THE VIABAHN DEVICE, AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE AND STAYED AT HOSPITAL EXTENDING FOR ONE MORE DAY. INSPECTING THE VIABAHN DEVICE AFTER PROCEDURE, THE DISTAL VIABAHN DEVICE ST

  Patient problems: Perforation

  MAUDE report 10064467 ↗