GORE VIABAHN Endoprosthesis with Heparin VBH100502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132623211), received between Sep 6, 2018 and Feb 16, 2021 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2021Physical Resistance/Sticking; Difficult or Delayed Separation

  DURING TREATMENT OF A SPLENIC ANEURYSM, A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) DID NOT ADVANCE TO THE SPLENIC ARTERY DUE TO TORTUOUS ANATOMY. ATTEMPTS WERE MADE TO WITHDRAW THE VIABAHN DEVICE THROUGH THE 12FR COOK SHEATH; HOWEVER, THE DEVICE COULD NOT BE WITHDRAWN. THE DEVICE WAS DEPLOYED IN THE GASTRODUODENAL ARTERY AND THE DEPLOYMENT LINE WAS PULLED OUT. HOWEVER, THE DELIVERY CATHETER BECAME STUCK AND COULD NOT BE REMOVED. DECISION WAS MADE TO HAVE THE TRANSPLANT SURGEON CUT AND REMOVE THE DELIVERY CATHETER DURING A SCHEDULED RENAL TRANSPLANT SURGERY ON (B)(6) 2020. (B)(4).

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 11335205 ↗
• InjuryFeb 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020, THE PATIENT UNDERWENT TREATMENT FOR A POPLITEAL ARTERY OCCLUSION USING GORE® VIABAHN® ENDOPROSTHESES. IT WAS REPORTED A GORE® VIABAHN® ENDOPROSTHESIS (VBH100502A/20466865) WAS ADVANCED INTO ITS INTENDED LOCATION. REPORTEDLY THE DEPLOYMENT LINE WAS PULLED, HOWEVER, THE DEVICE FAILED TO COMPLETELY EXPAND LEAVING A PORTION OF THE DEVICE CONSTRAINED. THE PHYSICIAN BALLOONED THE GORE® VIABAHN® ENDOPROSTHESIS AND THE DEVICE WAS FULLY EXPANDED. HOWEVER, AS THE DEPLOYMENT CATHETER WAS BEING REMOVED FROM THE PATIENT, IT WAS OBSERVED THAT THE POPLITEAL ARTERY HAD RUPTURED. THE PROCEDURE WAS COMPLETED WITH THE PHYSICIAN PERFORMING A FEM-POP BYPASS USING A VASCULAR GRAFT. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED IT IS UNKNOWN WHAT CAUSED THE PARTIAL DEVICE EXPANSION OR THE RUPTURE.

  Patient problems: Perforation of Vessels

  MAUDE report 9769531 ↗
• MalfunctionDec 20, 2019Material Separation; Material Separation

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH GORE® VIABAHN® ENDOPROSTHESES TO TREAT A POPLITEAL ANEURYSM. IT WAS REPORTED A .035 GUIDEWIRE WAS USED DURING THE PROCEDURE. THE SHEATH BRAND AND SIZE ARE REPORTEDLY UNKNOWN. IT WAS REPORTED DURING DEPLOYMENT, THE DEPLOYMENT LINE BROKE AND THE DEVICE WAS PARTIALLY OPENED APPROXIMATELY 98 PERCENT. THE PHYSICIAN REPORTEDLY STATED IS UNKNOWN WHAT CAUSED THE DEPLOYMENT LINE TO BREAK. IT WAS REPORTED THE CATHETER WAS CUT IN ORDER TO GAIN ACCESS TO THE REMAINING DEPLOYMENT LINE. THE DEPLOYMENT LINE WAS PULLED AND THE DEVICE WAS REPORTEDLY COMPLETELY OPENED. HOWEVER, A PORTION OF THE DEPLOYMENT LINE REMAINED IN THE PATIENT¿S BODY AND COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9500958 ↗
• MalfunctionJul 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: THE AV/DIALYSIS PATIENT PRESENTED FOR CENTRAL VENOUS AND CEPHALIC ARCH STENOSIS TREATMENT. THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN) WAS ADVANCED TO THE TREATMENT SITE IN THE CEPHALIC ARCH AND DEPLOYED WITHOUT ISSUE. HOWEVER, THE DEPLOYMENT LINE REMAINED ATTACHED TO THE VIABAHN. THE DOCTOR, ON A SEPARATE WIRE, ADVANCED A 10X4 MUSTANG¿ BALLOON INTO THE VIABAHN AND INFLATED IT TO FULL SIZE. THIS FIXATED THE VIABAHN ALLOWING THE DOCTOR TO PULL THE DEPLOYMENT LINE WHILE HIS ASSISTANT PUSHED ON THE BALLOON. THE COMBINATION OF SIMULTANEOUSLY PUSHING THE BALLOON AND PULLING THE DEPLOYMENT LINE FREED THE DEPLOYMENT LINE. THE DEPLOYMENT LINE WAS REMOVED FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 8817710 ↗
• InjuryDec 13, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING A PROCEDURE TO RELINE A PREVIOUSLY IMPLANTED STENT IN AN AV ACCESS APPLICATION IN THE SUBCLAVIAN VEIN WITH A GORE® VIABAHN® ENDOPROSTHESIS. THE DEVICE WAS ATTEMPTED TO BE ADVANCED WITHIN THE PREVIOUSLY IMPLANTED STENT, BUT IT WAS NOT POSSIBLE TO DO SO. THE UNDEPLOYED DEVICE WAS THEN WITHDRAWN AND AS IT WAS BEING WITHDRAWN IT BECAME STUCK ON THE EDGE OF THE SHEATH, CAUSING IT TO ACCORDION ON THE DELIVERY CATHETER. THE SHEATH AND DEVICE WERE THEN REMOVED. AS THEY WERE REMOVED, SOME VESSEL DAMAGE OCCURRED WHICH REQUIRED A CUT-DOWN AND SOME ADDITIONAL SUTURING. A NEW 10FR SHEATH WAS THEN INSERTED AND THE CASE WAS COMPLETED WITH A NON-GORE STENT. THE PATIENT DID WELL.

  Patient problems: Perforation of Vessels

  MAUDE report 8162024 ↗
• InjurySep 6, 2018Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING A PROCEDURE FOR ARTERIO-VENOUS ACCESS IN THE UPPER ARM WITH A GORE® VIABAHN® ENDOPROSTHESIS. THE ACCESS VESSEL WAS PRE-DILATED WITH AN 8FR SHEATH, THEN THE SHEATH WAS REMOVED. AN ATTEMPT WAS MADE TO ADVANCE THE DEVICE WITHOUT A SHEATH IN PLACE, BUT IT COULD NOT BE ADVANCED. THE DELIVERY SYSTEM WITH THE UNDEPLOYED STENT WAS REMOVED FROM THE PATIENT. UPON REMOVAL, IT WAS NOTED THE LEADING OLIVE TIP WAS MISSING FROM THE DELIVERY CATHETER. A CONVERSION TO OPEN REPAIR ENSUED. THE OLIVE TIP WAS NOT POSITIVELY IDENTIFIED, BUT THE SURGEON BELIEVES THE TIP WAS REMOVED IN THE PROCESS OF SUCTIONING AND CLEANING UP THE OPERATIVE SITE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852965 ↗