GORE VIABAHN Endoprosthesis with Heparin VBJR080202ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132623808), received between Aug 26, 2020 and Aug 26, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Positioning 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.

• InjuryAug 26, 2020Positioning Problem; Positioning Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT WAS BEING TREATED FOR STENOSIS WITHIN THE RENAL VEIN USING TWO GORE® VIABAHN® ENDOPROSTHESES. A ASAHI GRAND SLAM GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE THE VIABAHN (22283464) WAS ADVANCED TO ITS INTENDED LOCATION HOWEVER, DURING DEPLOYMENT THE DEVICE MOVED AN UNKNOWN AMOUNT. AN ADDITIONAL VIABAHN (22047427) WAS IMPLANTED FOR EXTENSION. BOTH STENTS WERE POST DILATED WITH AN 8X40 PTA BALLOON. AFTER BALLOONING, A 6FR PIGTAIL CATHETER WAS PLACED IN THE VEIN TO PERFORM AN ANGIOGRAM. BOTH IVUS AND THE SUBSEQUENT ANGIOGRAM CONFIRMED THE STENTS WERE IN THE DESIRED LOCATION. THE PIGTAIL CATHETER WAS REMOVED, HOWEVER UPON REMOVAL BOTH STENTS WERE PULLED FROM THE RENAL VEIN INTO THE INFERIOR VENA CAVA. THE STENTS THEN MIGRATED INTO TWO DIFFERENT LOCATIONS OF THE HEART. BOTH VIABAHNS WERE RETRIEVED BY A 25MM SNARE AND PULLED OUT OF THE BODY THROUGH A 24FR DYRSEAL SHEATH. THE STENTS REPORTEDLY LOOKED TO BE UNDAMAGED AND IT WAS DETERMINED BY THE PHYSICIAN THAT NOTHING WAS LEFT BEHIND IN THE PATIENT¿S BODY. ANOTHER VIABAHN WAS USED TO COMPLETE THE CASE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 10457653 ↗