GORE VIABAHN Endoprosthesis with Heparin VBJR080502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132623815), received between Aug 26, 2020 and Nov 5, 2025 — classified as 2 injuries, 6 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.

• InjuryNov 5, 2025Migration; Migration

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR SUPERFICIAL FEMORAL ARTERY (SFA) FISTULA DURING WHICH TWO GORE® VIABAHN® ENDOPROSTHESES WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICES) WERE IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN ACCESSED THE TARGET TREATMENT AREA VIA GROIN ACCESS USING A TERUMO 7FR INTRODUCER SHEATH AND A TERUMO 0.014" RUNTHROUGH® NS EXTRA FLOPPY CORONARY GUIDEWIRE. THE FIRST VIABAHN DEVICE WAS SUCCESSFULLY IMPLANTED DISTALLY IN THE SFA. SUBSEQUENTLY, A SECOND VIABAHN DEVICE (LSN (B)(6)) WAS DEPLOYED PROXIMALLY. HOWEVER, DURING WITHDRAWAL OF THE VIABAHN DELIVERY SYSTEM, THE DISTAL TIP OF THE SYSTEM CAUGHT THE EDGE OF THE PROXIMAL VIABAHN ENDOPROSTHESIS, CAUSING IT TO BE DRAGGED BACKWARD TOWARD THE SHEATH AND RESULTING IN COVERAGE OF THE PROFUNDA ARTERY. THERE WERE NO ATTEMPTS MADE TO PLACE THE VIABAHN DEVICE BACK INTO PLACE IN THE PROXIMAL SFA BEFORE REMOVING THE VIABAHN DEVICE SURGICALLY. THE PHYSICIAN SUSPECTS THAT THE DISTAL EDGE OF THE VIABAHN DEVICE DID NOT FULLY EXPAND AND LACKED ADEQUATE WALL APPOSITION. INTRAVASCULAR ULTRASOUND (IVUS) WAS UTILIZED DURING THE PROCEDURE. THE PATIENT IS CURRENTLY DOING WELL FOLLOWING THE PROCEDURE

  Patient problems: Obstruction/Occlusion

  MAUDE report 23481565 ↗
• MalfunctionOct 29, 2025Fracture; Fracture

  ON (B)(6) 2025, DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WITH ANOTHER BRAND STENT AS THE MAIN GRAFT, AND A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS TO BE DEPLOYED IN THE LEFT COMMON ILIAC ARTERY. A 14 FR SENTRANT INTRODUCER SHEATH WAS USED TO ADVANCE THE VIABAHN DEVICE OVER A 0.018¿ GLIDEWIRE ADVANTAGE WIRE. DUE TO THE TORTUOUS AND ANEURYSMAL NATURE OF THE PATIENT¿S VESSEL, THE VIABAHN DEVICE WAS UNABLE TO REACH THE INTENDED TREATMENT SITE. DURING WITHDRAWAL OF THE DEVICE THROUGH THE SHEATH, RESISTANCE WAS ENCOUNTERED, AND THE DISTAL TIP OF THE DEVICE WAS FRACTURED. THE DEVICE WAS PULLED BACK INTO THE SHEATH, AND BOTH WERE REMOVED AS ONE UNIT. IT WAS REPORTED NO COMPONENTS WERE LEFT IN THE PATIENT. THE PHYSICIAN DECIDED TO ADVANCE THE LONG SHEATH ALL THE WAY PAST TARGETED TREATMENT AREA TO FACILITATE EASE OF ADVANCEMENT THRU TORTUOSITY THEN ADVANCED A NEW SAME-SIZED VIABAHN DEVICE WHICH WAS IMPLANTED SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. IT WAS REPORTED THE PHYSICIAN SUSPECTS TORTUOSITY OF VESSEL AND LACK OF SUPPORT FROM 018 GUIDEWIRE CONTRIBUTED TO THE DISTAL TIP BREAK. PHYSICIAN STATED AN .03

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414411 ↗
• MalfunctionAug 12, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR A PERIPHERAL ARTERY DISEASE (PAD) WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS ATTEMPTED TO BE USED IN THE FEMORAL ARTERY. IT WAS REPORTED DURING A PROCEDURE, WHILE ADVANCING THE VIABAHN DEVICE OVER A BOSTON SCIENTIFIC V18 GUIDEWIRE THROUGH A TERUMO 7FR INTRODUCER SHEATH, IT WAS NOTED THAT THE DEVICE WOULD NOT DEPLOY. THE PHYSICIAN ATTEMPTED TO PULL THE DEPLOYMENT LINE MULTIPLE TIMES BUT WAS UNABLE TO MOVE BEYOND A CERTAIN POINT. REPORTEDLY, APPROXIMATELY 1 TO 2 INCHES OF THE DEPLOYMENT LINE WAS PULLED BEFORE RESISTANCE WAS ENCOUNTERED. ALTHOUGH THE PHYSICIAN SUCCESSFULLY REACHED THE TARGET TREATMENT AREA, DEPLOYMENT FAILED. THE DEPLOYMENT LINE WAS PULLED USING NORMAL TECHNIQUE AND EXCESSIVE FORCE WAS NOT APPLIED. THERE WAS NO DISTAL EXPANSION OR OPENING OF THE STENT OBSERVED. IT REMAINS UNCLEAR WHETHER THE PATIENT'S ANATOMY WAS TORTUOUS OR IF CALCIFIED VESSELS WERE PRESENT. THE DEVICE WAS WITHDRAWN FROM THE PATIENT BEFORE A NEW 8MM X 5CM VIABAHN DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN WAS UNABLE TO DETERMINE THE SUSPECTED CAUSE OF THE ISSUE. THE PATIENT DID NOT EXPERIENC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22789578 ↗
• MalfunctionNov 13, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2024, A PATIENT UNDERWENT A PROCEDURE FOR STENOTIC OCCLUSION WHERE A 8 MM X 5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (GORE® VIABAHN® DEVICE) WAS INTENDED TO BE USED IN THE RIGHT EXTERNAL ILIAC ARTERY. IT WAS REPORTED THE LESION WAS PREDILATED AND PREPPED USING AN 6 X 10 PENUMBRA DEVICE. THE PHYSICIAN ACCESSED THE PATIENT IPSILATERALLY. THE DELIVERY CATHETER WAS ADVANCED USING A 12F COOK SHEATH OVER AN UNKNOWN SIZE TERUMO GLIDEWIRE ADVANTAGE® PERIPHERAL GUIDEWIRES TO THE TARGET TREATMENT ZONE. IT WAS REPORTED THEY USED A 12F SHEATH DUE TO THE USE OF THE PENUMBRA DEVICE DURING PREPARATION. REPORTEDLY, THERE WAS NO RESISTANCE NOTICED DURING ADVANCEMENT OF THE DELIVERY CATHETER. DURING DEPLOYMENT, THE LINE WAS PULLED, AND THE DEPLOYMENT LINE BROKE APPROXIMATELY 2 CM FROM THE PROXIMAL END OF THE STENT. IT WAS REPORTED THE DEPLOYMENT LINE WAS PULLED USING THE NORMAL TECHNIQUE. THE DELIVERY CATHETER WAS REMOVED FROM THE PATIENT WITH THE ENDOPROSTHESIS FULLY CONSTRAINED. REPORTEDLY, THERE WERE NO CATHETER FRAGMENTS OR DEPLOYMENT LINE LEFT IN THE PATIENT THE PHYSICIAN DOES NOT HAVE ANY SUSPICIONS AS TO WHY THE LINE BECAME BROKE. THE PROCEDURE WAS COMPLETED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675749 ↗
• MalfunctionApr 3, 2024Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON MARCH 22, 2024, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE ARM DURING TREATMENT OF A CLOTTED GRAFT (ARTEGRAFT® COLLAGEN VASCULAR GRAFT). AFTER THE DEVICE WAS ADVANCED THROUGH THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN) OVER A 0.018" PLATINUM PLUS GUIDE WIRE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE. HOWEVER, THE ZIPPER BOUND AT THE TURN AROUND AND WAS UNABLE ACHIEVE ANY DEVICE EXPANSION. AFTER A FEW ATTEMPTS AND NO DEVICE EXPANSION THE PHYSICIAN REMOVED THE VSX DEVICE THROUGH THE INTRODUCER SHEATH. AN ADDITIONAL VSX DEVICE WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19035724 ↗
• MalfunctionOct 10, 2022Activation Problem; Activation Problem

  ON (B)(6) 2022, A PATIENT PRESENTED FOR A-V FISTULA TREATMENT IN THE LEFT UPPER ARM. A FISTULOGRAM AND THROMBECTOMY WERE PERFORMED. AS REPORTED, THE TREATMENT AREA WITHIN THE PRE-EXISTING BARE METAL STENT (BMS) WAS DILATED PRIOR TO INSERTING THE 8MM X 5CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICE). THE VSX DEVICE WAS ADVANCED OVER A VICTORY 0.18 WIRE THROUGH A 7FR SHORT SHEATH. DURING DEPLOYMENT, THE VSX DEVICE EXPANDED ABOUT HALF WAY WHEN THE DEPLOYMENT LINE BROKE. THE PHYSICIAN WAS ABLE TO PULL OUT EVERYTHING (DEVICE, CATHETER AND ALL OF DEPLOYMENT LINE) FROM THE PATIENT. A NEW 8MM X 5CM VSX DEVICE WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15571761 ↗
• MalfunctionJul 22, 2021Difficult to Advance; Activation Failure; Difficult to Advance; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT PRESENTED WITH STENOSIS IN AN AV FISTULA AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX) DEVICE. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE GUIDEWIRE, CATHETER, AND BALLOON TO THE LESION DUE TO THE PATIENTS TORTUOUS ANATOMY. THE PHYSICIAN WAS ULTIMATELY ABLE TO ADVANCE THE DEVICE TO THE LESION, BUT WHEN HE ATTEMPTED TO DEPLOY THE VSX DEVICE, THE DISTAL END OF THE DEVICE WOULD NOT FULLY DEPLOY. THE PHYSICIAN COMPLETELY REMOVED THE DEVICE AND DELIVERY SYSTEM. THE PHYSICIAN REPORTED THAT HE WAS ABLE TO FULLY DEPLOY THE DEVICE ONCE IT WAS OUTSIDE OF THE PATIENT, SO HE SUSPECTS THE PARTIAL DEPLOYMENT WAS DUE TO TORTUOUS ANATOMY AND CALCIFICATION AND NOT A DEFECT WITH THE DEVICE. THE DEVICE WILL BE RETURNED. NO OTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211815 ↗
• 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 10457515 ↗