GORE VIABAHN Endoprosthesis with Heparin VBJR051502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132623921), received between Aug 6, 2018 and Dec 26, 2024 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2024Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY DURING TREATMENT OF AN ANEURYSM. AFTER THE VSX DEVICE WAS ADVANCE ACROSS THE LESION OVER A V18 GUIDE WIRE, HE ATTEMPTED TO DEPLOY THE DEVICE. HOWEVER, AFTER THE DEPLOYMENT WAS INITIATED, THE DEPLOYMENT LINE GOT HUNG UP AND STARTED TO BOWSTRING THE VSX DEVICE. WITH THE INABILITY TO COMPLETE DEPLOYMENT, THE PHYSICIAN REMOVED THE VSX DEVICE. THE CASE WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL VSX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021418 ↗
• MalfunctionSep 14, 2022Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT PRESENTED FOR TREATMENT OF A STENOTIC SUPERFICIAL FEMORAL ARTERY UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICE). DURING TREATMENT IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY, ACCESS WAS GAINED FROM UP AND OVER BIFURCATION. A VSX DEVICE WAS ADVANCED AND PLACED AT THE TARGET LESION. DEPLOYMENT WAS INITIATED, AND WHEN DEVICE BEGAN TO EXPAND, A POPPING SOUND WAS HEARD AND THE DEPLOYMENT LINE BECAME STUCK. DEPLOYMENT COULD NOT BE CONTINUED. THE PHYSICIAN WAS ABLE TO RE-SHEATH AND REMOVE THE PARTIALLY EXPANDED DEVICE. A NEW VSX DEVICE WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419788 ↗
• InjuryAug 17, 2021Break; Activation, Positioning or Separation Problem; Difficult or Delayed Separation; Difficult or Delayed Separation

  ON AN UNKNOWN DATE, THE PATIENT PRESENT WITH A NON-HEALING ULCER. ADDITIONALLY, COMPUTED TOMOGRAPHY ANGIOGRAPHY IDENTIFIED THROMBUS AND ASSOCIATED PLAQUE IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. IT WAS NOTED THERE WAS NOT A COMPLETE OCCLUSION. THE GUIDING SHEATH WAS ADVANCED UP AND OVER THE BIFURCATION, HOWEVER, IT ONLY REACHED THE COMMON FEMORAL ARTERY. THE VALVE OF THE SHEATH WAS IMMEDIATELY ADJACENT TO THE ACCESS SITE. A ATHERECTOMY WAS PERFORMED WITH A DISTAL FILTER IN PLACE. NEXT A BALLOON ANGIOPLASTY OF THE LESION WAS PERFORMED. THERE WAS A RESIDUAL CLOT AND DISSECTION AROUND THE LOCATION OF THE PLAQUE. THE PHYSICIAN DECIDED TO COVER THE LOCATIONS USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WITH A 1:1 SIZING OF DEVICE TO VESSEL. THE DELIVERY CATHETER WAS ADVANCED TO ITS INTENDED LOCATION WITH NO ISSUE. THE PHYSICIAN SLOWLY STARTED PULLING THE DEPLOYMENT LINE AND FELT NO RESISTANCE. THE PHYSICIAN CONFIRMED THE CATHETER WAS ORIENTED STRAIGHT OUT OF THE CATHETER WHILE PULLING THE DEPLOYMENT LINE. HALFWAY THROUGH THE DEPLOYMENT THE DEPLOYMENT LINE SNAPPED. THE STENT GRAFT REMAINED PARTIALLY DEPLOYED. THE PHYSICIAN ATTEMPTED TO CUT BACK THE CATHETER TO

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 12334104 ↗
• MalfunctionMar 6, 2020Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6) 2020, THE PATIENT UNDERWENT TREATMENT OF PERCUTANEOUS DEEP VEIN ARTERIALIZATION IN THE POSTERIOR TIBIAL ARTERY USING GORE® VIABAHN® ENDOPROSTHESES (VIABAHN) AND A RESOLUTE ONYX MEDTRONIC BALLOON EXPANDABLE DRUG ELUTING STENT. IT WAS REPORTED THE PHYSICIAN DEPLOYED THE 4MM X 38MM RESOLUTE ONYX MEDTRONIC BALLOON EXPANDABLE DRUG ELUTING STENT IN THE POSTERIOR TIBIAL ARTERY. THE PHYSICIAN THEN UNSUCCESSFULLY ATTEMPTED TO INTRODUCE A (5X25) VIABAHN MULTIPLE TIMES. THE PHYSICIAN WAS UNABLE TO TRACK THE DEVICE ACROSS THE PREVIOUSLY IMPLANTED BALLOON EXPANDABLE STENT (ONYX), DUE TO THE TIGHT NATURE OF THE JUNCTION. THE PHYSICIAN POST DILATED THE ONYX WITH BOTH 3MM AND 5MM BALLOONS. IT WAS REPORTED THE VBX SUCCESSFULLY TRACKED AND DEPLOYED INTO THE POSTERIOR TIBIAL VEIN. THE PHYSICIAN THEN SUCCESSFULLY ADVANCED A (5X15) VIABAHN THROUGH THE EXISTING (5X25) VIABAHN AND ONYX DEVICE TO EXTEND OFF OF THE PREVIOUSLY IMPLANTED VIABAHN. DURING DEPLOYMENT OF THE (5X15) VIABAHN THE DEPLOYMENT KNOB WAS PULLED AND ONLY A PORTION OF THE DEPLOYMENT LINE CAME OUT OF THE HUB, LEAVING THE DEVICE PARTIALLY CONSTRAINED. IT WAS REPORTED THE DEPLOYMENT LINE BROKE AT THE END OF THE CATHETER INSIDE OF T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9800248 ↗
• InjuryDec 9, 2019Activation Failure; Material Split, Cut or Torn; Activation Failure; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED TO THE GORE FSA: THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN) WAS TRACKED THROUGH A 6FR TERUMO SHEATH OVER A TERUMO ADVANTAGE .018 WIRE FROM A CONTRA LATERAL APPROACH INTO THE LEFT SFA. THE LESION WAS MID TO DISTAL SFA. THE DOCTOR PRE-DILATED WITH A 3X80 ULTRAVERSE® .018 BALLOON. THE VIABAHN WAS POSITIONED WITH A 1CM OVERLAP INTO A PREVIOUSLY PLACED 5X5 VIABAHN. ON DEPLOYMENT, THE DEPLOYMENT LINE WAS PULLED AND ALMOST HALF OF THE IMPLANT DEPLOYED WHEN THE DEPLOYMENT LINE BROKE. THE PROXIMAL HALF OF THE VIABAHN WAS OBSERVED TO BE UNDEPLOYED IN PATIENT. THE HUB OF VIABAHN WAS CUT OFF AND A LONGITUDINAL CUT MADE INTO THE VIABAHN CATHETER TO EXPOSE THE DEPLOYMENT LINE, HOWEVER, NO LINE WAS THERE. THE DOCTOR ATTEMPTED TO MOVE THE CATHETER BACK AND FORTH BUT THE PATIENT FELT PAIN IN THE LEG. SO THE PROCEDURE WAS CONVERTED TO OPEN BYPASS TO REMOVE DEVICE. THE DOCTOR OPENED THE IPSILATERAL GROIN. HE THEN TOOK AN 11 BLADE AND CUT OPEN THE 6FR SHEATH AND THE VIABAHN CATHETER, FOUND THE DEPLOYMENT LINE, WHICH WAS FRAYED, AND PULLED IT UNTIL IT ALL CAME OUT. THE TECH WALKED BACK THE CATHETER OUT OF THE BODY ON THE CONTRA SIDE THEN REMOVED THE SHEATH, THE DOCTOR CUT TH

  Patient problems: Occlusion

  MAUDE report 9440190 ↗
• MalfunctionAug 14, 2019Mechanical Problem; Detachment of Device or Device Component; Activation Failure; Mechanical Problem; Detachment of Device or Device Component; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE BY THE DOCTOR: THE PATIENT PRESENTED WITH TOTAL OCCLUSION OF THE SFA. ACCORDING TO THE DOCTOR, THE DEPLOYMENT LINE BROKE AFTER THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN) WAS 80 PERCENT DEPLOYED. THE PHYSICIAN THEN PERFORMED A POPLITEAL STICK AND ACCESS. THIS ALLOWED ACCESS FOR A GUIDE WIRE AND PTA BALLOON TO BE PLACED IN THE PARTIALLY DEPLOYED VIABAHN. THE PTA BALLOON WAS INFLATED WITHIN THE VIABAHN, SUCCESSFULLY DEPLOYING THE VIABAHN. IT WAS REPORTED THAT THE PATIENT IS DOING WELL.

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

  MAUDE report 8895455 ↗
• MalfunctionAug 9, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF A SUPERFICIAL FEMORAL ARTERY IN-STENT STENOSIS. THE INTENT WAS TO RELINE THE STENT WITH A GORE® VIABAHN® ENDOPROSTHESIS. WHEN THE DEVICE WAS ADVANCED TO THE TARGET LOCATION, DEPLOYMENT WAS ATTEMPTED, BUT AFTER THE DEVICE WAS DEPLOYED HALF WAY, THE DEPLOYMENT LINE BROKE. THE DELIVERY CATHETER WAS THEN CUT TO TRY TO EXPOSE THE REMAINING DEPLOYMENT LINE. THE DELIVERY CATHETER WAS PEELED OPEN AND THE DEPLOYMENT LINE WAS EXPOSED. THE DEPLOYMENT LINE WAS PULLED, AND DEPLOYMENT WAS COMPLETED. UPON REMOVAL OF THE DELIVERY SYSTEM IT WAS NOTED THE DEPLOYMENT LINE WAS KNOTTED. A SECOND DEVICE WAS DEPLOYED TO COMPLETE THE TREATMENT AND THE PATIENT OUTCOME WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8880306 ↗
• InjuryAug 6, 2018Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: THE GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED TO THE DISTAL SFA POPLITEAL AREA. THE DOCTOR BEGAN TO PULL THE DEPLOYMENT LINE. THE DEPLOYMENT LINE BROKE DURING DEPLOYMENT. THE PATIENT WAS TAKEN TO THE OR AND THE DOCTOR SURGICALLY REMOVED THE DEVICE.

  Patient problems: Occlusion

  MAUDE report 7752852 ↗