GORE VIABAHN Endoprosthesis with Heparin VBHR071002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132622986), received between Jan 20, 2021 and May 12, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2022Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) DURING AN AAA CASE WITH HYPOGASTRIC PRESERVATION BILATERALLY. THE PHYSICIAN GAINED ACCESS WITH A RIGHT SIDED GROIN PUNCTURE AND INSERTED A 9 FR TERUMO PINNACLE® SHEATH UP AND OVER THE AORTIC BIFURCATION TO REACH THE LEFT HYPOGASTRIC ARTERY. THE VIABAHN DEVICE WAS LOADED ONTO AN AMPLATZ WIRE WITH INTENTION TO TRACK TO THE DISTAL INTERNAL ILIAC ARTERY. THE PHYSICIAN WAS EXPERIENCING DIFFICULTY ADVANCING THE VIABAHN DEVICE UP AND OVER THE AORTIC BIFURCATION DUE TO PATIENT TORTUOSITY, AND WAS APPLYING QUITE A BIT OF FORCE TO GET THE VIABAHN DEVICE TO TRACK. WHILE MANIPULATING THE CATHETER BACK AND FORTH TO AID ADVANCEMENT, THE PHYSICIAN PULLED THE VIABAHN DEVICE BACK AND THE ENDOPROSTHESIS ACCORDIONED ON THE PROXIMAL END. THE CATHETER THEN BROKE OFF AT THE TRANSITION OF THE CATHETER AND THE VIABAHN DEVICE. THE PHYSICIAN SAW THE EXPOSED DEPLOYMENT LINE AND CUT THE LINE, ADDED A HEMOSTAT TO MAINTAIN CONTROL, AND PULLED THE VIABAHN DEVICE OFF OF THE CATHETER. THE VIABAHN REMAINED CONSTRAINED, BUT WAS UNABLE TO BE PUSHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14373681 ↗
• InjuryFeb 26, 2021Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON AN UNKNOWN DATE IN (B)(6) 2020, THE PATIENT UNDERWENT TREATMENT FOR ENDOFIBROSIS IN THE PATIENT¿S LEFT EXTERNAL ILIAC ARTERY USING A GORE® VIABAHN® ENDOPROSTHESIS. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH PAIN REPORTEDLY DUE TO DERMATITIS. ON AN UNKNOWN DATE, THE PATIENT TESTED POSITIVE FOR BOTH A NICKEL AND GOLD ALLERGY. ON AN UNKNOWN DATE, OCCLUSION OF THE GORE® VIABAHN® ENDOPROSTHESIS WAS IDENTIFIED. ON (B)(6) 2021, THE PATIENT UNDERWENT A REINTERVENTION WHEREBY THE GORE® VIABAHN® ENDOPROSTHESIS WAS EXCISED IN CONTINUITY WITH THE EXTERNAL ILIAC ARTERY. THE PATIENTS ANATOMY WAS RECONSTRUCT WITH A DACRON GRAFT. THE PHYSICIAN REPORTEDLY DECIDED TO EXPLANT THE DEVICE DUE TO THE PATIENT¿S DERMATITIS AND RELATED PAIN AS WELL AS THE IDENTIFIED OCCLUSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Hypersensitivity/Allergic reaction; Obstruction/Occlusion; Pain

  MAUDE report 11389186 ↗
• MalfunctionJan 20, 2021Premature Activation; Premature Activation

  ON (B)(6)2020, THE PATIENT WAS BEING TREATED FOR PERIPHERAL VASCULAR DISEASE IN THE EXTERNAL ILIAC USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE DEPLOYED WITHIN THE SHEATH. IT WAS REPORTED THE DEVICE DEPLOYED IN THE SHEATH WITH A SMALL PORTION OF THE DEVICE EXTENDING OUTSIDE OF THE SHEATH. THE PHYSICIAN'S SUSPECTED CAUSE OF THE DEVICE DEPLOYING IN THE SHEATH IS UNKNOWN. BOTH THE SHEATH AND DEVICE WERE REMOVED FROM THE PATIENT. ANOTHER GORE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11205355 ↗