GORE VIABAHN Endoprosthesis with Heparin VBJR061002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132623969), received between Oct 9, 2018 and Feb 26, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY DURING TREATMENT OF A FISTULA. REPORTEDLY, AFTER BALLOONING, A QUESTIONABLE AV FISTULA FORMED THAT THE PHYSICIAN WANTED TO COVER AND SEAL. THE PHYSICIAN ADVANCED THE VSX DEVICE OVER A 0.018" GLIDE WIRE ADVANTAGE INTO POSITION AND ATTEMPTED TO DEPLOY THE VSX DEVICE. HOWEVER, AFTER DEPLOYMENT WAS INITIATED, THE DEPLOYMENT LINE HUNG UP AFTER A FEW INCHES. THE PHYSICIAN DID NOT WANT TO PULL HARDER AND BREAK THE DEPLOYMENT LINE AND REMOVED THE VSX DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW VSX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457244 ↗
• MalfunctionAug 12, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, DURING AN ENDOVASCULAR TREATMENT, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED TO BE IMPLANTED IN THE RIGHT LOWER EXTREMITY, POPLITEAL ARTERY. THE TARGET TREATMENT AREA WAS REACHED WITH NO KNOWN RESISTANCE BY USING AN UNKNOWN SHEATH WITH A .018" GUIDEWIRE (MANUFACTURE UNKNOWN). THE PHYSICIAN INITIATED DEPLOYMENT BY PULLING ON THE DEPLOYMENT LINE. ITS BELIEVED THE DEPLOYMENT LINE WAS PULLED ALL THE WAY, NOTICING NOTHING OUT OF THE ORDINARY, WHEN THE VIABAHN DEVICE DID NOT DEPLOY. THERE WERE NO REPORTS OF DEVICE EXPANSION. THE VIABAHN DEVICE WAS WITHDRAWN THROUGH THE SHEATH (FOR RETURN) AND THE PROCEDURE WAS COMPLETED USING A NEW SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787311 ↗
• MalfunctionMar 4, 2025Activation Problem; Activation Problem

  ON (B)(6) 2025, A PATIENT RECEIVED TREATMENT FOR A PERFORATION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA), UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE). IT WAS REPORTED THAT DURING THE PROCEDURE, THE VIABAHN® DEVICE FAILED TO DEPLOY. A 6FR TERUMO DESTINATION BRAND SHEATH AND A TERUMO GLIDEWIRE ADVANTAGE BRAND GUIDEWIRE WERE UTILIZED. THE TARGET LESION HAD REPORTEDLY BEEN PREDILATED. IT WAS REPORTED THAT THERE WAS NO DISTAL EXPANSION OR OPENING OF THE STENT. ANOTHER VIABAHN® DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516407 ↗
• MalfunctionSep 18, 2024

  WE WERE ONLY ABLE TO DEPLOY THE DISTAL PORTION OF THE STENT AND THE STENT BECAME STUCK IN THIS LOCATION. MULTIPLE ATTEMPTS TO FURTHER DEPLOY THE VIABAHN STENT WITH THE STRING WERE MET WITH RESISTANCE AND BENDING OF THE CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245481 ↗
• MalfunctionAug 13, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR STENOTIC OCCLUSION WHERE A 6 MM X 10 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (GORE® VIABAHN® DEVICE) WAS INTENDED TO BE USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED THE PHYSICIAN USED ROTAREX¿ ROTATIONAL EXCISIONAL ATHERECTOMY SYSTEM AND THEN ACCESSED THE PATIENT USING A 6F MERIT MEDICAL ROADSTER GUIDE SHEATH OVER AN .018" ABBOTT COMMAND GUIDE WIRE TO THE TARGET TREATMENT ZONE. REPORTEDLY, THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THE DELIVERY CATHETER. DURING DEPLOYMENT, THE LINE WAS PULLED AND BECAME STUCK. THE ENDOPROSTHESIS STARTED TO BUCKLE ('COBRA HEAD') AND WOULD NOT RELEASE. REPORTEDLY, THERE WAS NO DISTAL EXPANSION INITIATED AND THE DEPLOYMENT LINE DID NOT BREAK. THE PHYSICIAN WITHDREW THE CATHETER, WITH THE ENDOPROSTHESIS FULLY CONSTRAINED. THE PROCEDURE WAS COMPLETED USING ANOTHER 6 MM X 10 CM GORE® VIABAHN® DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975330 ↗
• MalfunctionMay 23, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR STENOSIS IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY / PROXIMAL POPLITEAL ARTERY USING A 6 MM X 10 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE). IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT VIA THE RIGHT GROIN UP-AND-OVER USING A 7F PINNACLE® DESTINATION® GUIDING SHEATH (90 CM) OVER A 0.018" COMMAND GUIDEWIRE TO THE TARGET TREATMENT ZONE. REPORTEDLY, THE LESION WAS NOT PREDILATED, AND IT WAS TIGHT ADVANCING THE CATHETER TO THE LANDING ZONE DUE TO THE STENOSIS. DURING THE ATTEMPTED DEPLOYMENT, THE DEPLOYMENT LINE WAS PULLED AND ENDOPROSTHESIS INITIATED DISTAL EXPANSION (ABOUT 1 CM) AND THEN BECAME STUCK. THE PHYSICIAN MANIPULATED (MOVED AROUND) THE CATHETER AND ATTEMPTED TO PULL AGAIN. THE DEPLOYMENT LINE WAS STILL STUCK, THE DEVICE STARTED TO BOWSTRING AND DEPLOYMENT WAS ABORTED. DUE TO CONCERN THE LINE MAY BREAK, THE DECISION WAS MADE TO WITHDRAW THE DELIVERY CATHETER. DURING WITHDRAWAL, THE DELIVERY CATHETER WAS PULLED CLOSE TO THE SHEATH, AND BOTH WERE PULLED BACK UP AND OVER THE AORTIC BIFURCATION. THE PHYSICIAN COULD NOT PULL THE DELIVERY CATHETER ALL THE WAY BACK INTO THE SHEATH DUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382833 ↗
• MalfunctionJun 2, 2022Activation Problem; Activation Problem

  ON (B)(6) 2022, THE PATIENT WAS TREATED FOR A PSEUDOANEURYSM IN THE FEMORAL ARTERY USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE DEVICE WAS DELIVERED THROUGH A 7FR TERUMO DESTINATION SHEATH OVER A V-18 WIRE. THE DEVICE MET RESISTANCE ADVANCING THROUGH THE SHEATH. HOWEVER, THE DEVICE WAS ABLE TO BE ADVANCED TO THE INTENDED TARGET LESION. THE DEVICE WAS ATTEMPTED TO BE DEPLOYED. THE DEPLOYMENT LINE WAS PULLED AND THE DEVICE PARTIALLY EXPANDED. THE PHYSICIAN WITHDREW THE PARTIALLY EXPANDED DEVICE BACK THROUGH THE SHEATH. THE PHYSICIANS STATED THE SUSPECTED CAUSE OF THE PARTIAL DEPLOYMENT IS UNKNOWN. ANOTHER GORE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580698 ↗
• MalfunctionJan 9, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  THE FOLLOWING WAS REPORTED TO GORE: THE DOCTOR REPORTED THAT DURING AN UP AND OVER CASE, THE DEVICE WAS POSITIONED OVER A .014 WIRE AND DEPLOYMENT INITIATED. HOWEVER, THERE WAS NO TENSION ON THE DEPLOYMENT LINE AND THE DEPLOYMENT LINE WAS PULLED COMPLETELY OUT WITHOUT DEVICE EXPANSION. THE DEVICE WAS REMOVED FROM THE PATIENT.

  Patient problems: Occlusion

  MAUDE report 9570886 ↗
• MalfunctionDec 1, 2018Deformation Due to Compressive Stress; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS BEING TREATED EMERGENTLY FOR A HEMORRHAGE. A GORE® VIABAHN® ENDOPROSTHESIS WAS LOADED OVER A .018" WIRE AND ADVANCED, BUT DURING ADVANCEMENT, THE DELIVERY CATHETER BROKE. THE DEVICE WAS REMOVED ENTIRELY AND A SECOND DEVICE WAS ADVANCED AND DEPLOYED SUCCESSFULLY. THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT. DURING THE COURSE OF THE INVESTIGATION IT WAS LEARNED THAT THE DELIVERY CATHETER DID NOT BREAK APART, BUT RATHER IT KINKED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8123024 ↗
• MalfunctionOct 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF UNKNOWN TYPE AND ANATOMICAL LOCATION WITH A GORE® VIABAHN® ENDOPROSTHESIS. WHEN DEPLOYMENT WAS ATTEMPTED, THE PROXIMAL END OF THE STENT WOULD NOT EXPAND. THE DELIVERY CATHETER WAS THEN PULLED BACK AND THE STENT CAME BACK WITH IT. THE DELIVERY CATHETER THEN SEPARATED FROM THE STENT AND THEN THE STENT DEPLOYED. A SECOND STENT WAS NEEDED TO BRIDGE TO THE FIRST ONE, AND THE PROCEDURE WAS CONCLUDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7947558 ↗