GORE VIABAHN Endoprosthesis with Heparin VBH101002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132623228), received between Aug 7, 2018 and Jan 7, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019 THE PATIENT PRESENTED WITH THROMBUS IN AN ANEURYSM FOUND IN THE LEFT AXILLARY ARTERY. THE PATIENT SHOWED LITTLE TO NO FLOW IN THE LOWER LEFT UPPER EXTREMITY (HAND) PRIOR TO THE PROCEDURE. A DECLOTTING PROCEDURE WAS PERFORMED PRIOR TO TREATING THE LESION. THE PHYSICIAN MADE THE DECISION TO ADVANCE A 10MM X 10 CM GORE® VIABAHN® ENDOPROSTHESIS ON A 0.035" AMPLATZ GUIDEWIRE WITH NO INTRODUCER SHEATH. THE DEVICE WOULD NOT CROSS THE LESION AND WAS REMOVED. THE PHYSICIAN THEN INSERTED AN 11FR PINNACLE DESTINATION SHEATH AND ELECTED TO USE THE SAME DEVICE. THE DEVICE WAS THEN ADVANCED ACROSS THE LESION AND SUCCESSFULLY DEPLOYED. HOWEVER, DURING DEPLOYMENT, THE DEPLOYMENT LINE GOT HUNG UP ON THE DEVICE. THE PHYSICIAN CUT THE DEPLOYMENT KNOB AND REMOVED THE CATHETER. THE DECISION WAS MADE TO INSERT THE DEPLOYMENT LINE THROUGH A 5FR X 45CM TERUMO SHEATH AND ADVANCE THE SHEATH TO THE DEVICE. WHILE PUSHING THE SHEATH AND PULLING THE DEPLOYMENT LINE THE PHYSICIAN WAS SUCCESSFUL IN THE DETACHING THE DEPLOYMENT LINE FROM THE DEVICE. AN ADDITIONAL 10MM X 5CM GORE® VIABAHN® ENDOPROSTHESIS DEVICE WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9558644 ↗
• MalfunctionMar 13, 2019Premature Activation; Premature Activation

  MEDWATCH #(B)(4) WAS RECEIVED. THE DESCRIPTION OF EVENT REPORTED TO GORE IS AS FOLLOWS: GORE® VIABAHN® ENDOPROSTHESIS TRACKED TO THE LEFT INTERNAL ILIAC ARTERY ANEURYSM BUT WOULD NOT TRACK TO THE DISTAL INTERNAL ILIAC ARTERY. THE DOCTOR THEN PERFORMED BALLOON ANGIOPLASTY OF THE DISTAL ORIFICE OF THE INTERNAL ILIAC ARTERY USING A 7MM X 4CM BALLOON. THE DOCTOR THEN TRACKED THE GORE® VIABAHN® ENDOPROSTHESIS TO THE LEFT INTERNAL ILIAC ARTERY ANEURYSM BUT AGAIN IT WOULD NOT TRACK TO THE DISTAL INTERNAL ILIAC ARTERY. AT THIS POINT THE GORE® VIABAHN® ENDOPROSTHESIS PARTIALLY DEPLOYED 2 RINGS OF THE STENT WITHOUT PULLING THE TRIGGER TO DEPLOY. THIS COULD NOT BE RE-CAPTURED WITHIN THE SHEATH. THE DOCTOR THEN REMOVED THE GORE® VIABAHN® ENDOPROSTHESIS WHILE PARTIALLY DEPLOYED. ACCORDING TO THE MEDWATCH RECEIVED, THIS CAUSED TRAUMA TO THE LEFT ILIAC ARTERY AND LEFT CFA.

  Patient problems: Aneurysm

  MAUDE report 8417431 ↗
• MalfunctionFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WITH A PREVIOUSLY IMPLANTED MEDTRONIC ENDURANT ABDOMINAL AORTIC DEVICE UNDERWENT TREATMENT OF A LEFT ILIAC ARTERY ANEURYSM. THE INTENT WAS TO EXTEND THE ENDURANT DEVICE WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES, AND MORE DISTALLY WITH A GORE® VIABAHN® ENDOPROSTHESIS. FOLLOWING PLACEMENT OF THE ILIAC BRANCH COMPONENTS, THE VIABAHN DEVICE WAS ATTEMPTED TO BE ADVANCED OVER A ROSEN FROM THE RIGHT SIDE IN AN UP AND OVER THE FLOW DIVIDER OF THE ENDURANT DEVICE TO THE INTERNAL ILIAC ARTERY. HOWEVER THE DEVICE COULD NOT TRACK ALL THE WAY TO THE INTERNAL ILIAC ARTERY, SO IT WAS WITHDRAWN THROUGH THE SHEATH. THE WIRE WAS EXCHANGED FOR AN AMPLATZ WIRE AND ADVANCEMENT WAS ATTEMPTED AGAIN, HOWEVER THE DEVICE STILL COULD NOT TRACK TO THE DESIRED LOCATION. UPON ATTEMPTED REMOVAL THE DEVICE SEEMED TO BE CATCHING ON SOMETHING AND ADDITIONAL FORCE WAS APPLIED TO TRY TO WITHDRAW THE DEVICE. THIS RESULTED IN THE DEVICE BECOMING SEPARATED FROM THE DELIVERY CATHETER. IT IS NOT KNOWN EXACTLY WHERE THE DEVICE LANDED BUT IT WAS SECURED IN PLACE WITH DEPLOYMENT OF TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. THE TRE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8329852 ↗
• MalfunctionJan 10, 2019Premature Activation; Premature Activation

  THE FOLLOWING WAS REPORTED TO GORE: THE GORE® VIABAHN® ENDOPROSTHESIS STARTED TO DEPLOY AT THE DISTAL END AND BECAME STUCK IN THE ILIAC ARTERY. THE PHYSICIAN USED THE APPROPRIATE SHEATH SIZE TO GO UP AND OVER THE BIFURCATION INTO THE INTERNAL ILIAC ARTERY. AS REPORTED, THERE WAS RESISTANCE DURING ADVANCEMENT, AND THE VIABAHN DEVICE STARTED EXPANDING FROM THE DISTAL END AND GOT STUCK. MORE INFORMATION WAS REQUESTED BUT NOT MADE AVAILABLE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8236908 ↗
• InjuryAug 7, 2018Entrapment of Device; Entrapment of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ADJUNCTIVELY THE PATIENT WAS INTENDED TO BE TREATED WITH A GORE® VIABAHN® ENDOPROSTHESIS FOR A HEAVILY CALCIFIED EXTERNAL ILIAC ARTERY STENOSIS. THE DEVICE WAS ADVANCED OVER A .035¿ AMPLATZ WIRE THROUGH AN 18FR SHEATH TO THE TARGET LOCATION. WHEN DEPLOYMENT WAS INITIATED, THE MIDDLE SECTION OF THE ENDOPROSTHESIS EXPANDED, WHILE THE PROXIMAL AND DISTAL SECTIONS REMAINED CONSTRAINED, SINCE THERE WAS A LARGE SHEATH IN PLACE, IT WAS DECIDED IT MAY BE POSSIBLE TO REMOVE THIS DEVICE. WHEN THE DEVICE WAS PULLED BACK, THE DISTAL END BEGAN EXPANDING. AT THIS POINT THE DEVICE WAS PARTIALLY OUTSIDE OF THE PATIENT¿S BODY, IN THE LIKENESS OF A CONDUIT. IT WAS THEN POSSIBLE TO ADVANCE ANOTHER VIABAHN, INSIDE, TO CONNECT TO THE LEADING END OF THE FIRST DEVICE TO COMPLETE THE TREATMENT. THE ENDOPROSTHESIS SEGMENT THAT WAS OUTSIDE OF THE BODY WAS CUT OFF. THE ACCESS SITE WAS REPAIRED WITH A CARDIOVASCULAR PATCH AND THE GROIN INCISION WAS CLOSED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 7758628 ↗