GORE VIATORR TIPS EndoprosthesisRecalls & reported problems across all models

We found 5 models of GORE VIATORR TIPS Endoprosthesis by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2018 and May 26, 2026 — classified as 11 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GORE VIATORR TIPS Endoprosthesis problems

GORE VIATORR TIPS Endoprosthesis models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE VIATORR TIPS Endoprosthesis PTB8108275

  Shunt, Portosystemic, Endoprosthesis
  15 reports
• GORE VIATORR TIPS Endoprosthesis PTB8106275

  Shunt, Portosystemic, Endoprosthesis
  5 reports
• GORE VIATORR TIPS Endoprosthesis PTB8107275

  Shunt, Portosystemic, Endoprosthesis
  3 reports
• GORE VIATORR TIPS Endoprosthesis PTB8104275

  Shunt, Portosystemic, Endoprosthesis
  1 report
• GORE VIATORR TIPS Endoprosthesis PTB8105275

  Shunt, Portosystemic, Endoprosthesis
  1 report

Recent GORE VIATORR TIPS Endoprosthesis adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THE PHYSICIAN SELECTED A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. THE STENT WAS SUCCESSFULLY PLACED; HOWEVER, WHEN THE STENT WAS APPROXIMATELY 80% DEPLOYED, THE DEPLOYMENT LINE BROKE AND THE END OF THE COVERED PORTION OF THE STENT REMAINED CONSTRAINED. ADDITIONAL MANIPULATION OF THE INTRODUCER SHEATH AND DELIVERY SYSTEM FREED THE REMAINING PORTION OF DEPLOYMENT LINE AND THE STENT FULLY DEPLOYED. THE SMALL PIECE OF DEPLOYMENT LINE THAT WAS STILL ATTACHED TO THE STENT REMAINED IN THE PATIENT, MOST LIKELY CONSTRAINED BETWEEN THE LIVER AND STENT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25277876 ↗
• MalfunctionMay 4, 2026Activation Failure

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION. DURING DEVICE DEPLOYMENT, THE STENT PARTIALLY DEPLOYED. THE LAST 2CM OF THE PROXIMAL END COULD NOT BE DEPLOYED. THE DEVICE WAS MOSTLY RECAPTURED INTO THE SHEATH AND REMOVED FROM THE PATIENT. A NEW VIATORR DEVICE WAS IMPLANTED WITH NO ISSUES. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069613 ↗
• MalfunctionJul 22, 2025Difficult to Advance; Material Deformation; Material Split, Cut or Torn

  PHYSICIAN TRIED TO ADVANCE STENT INTO SHEATH, IT WOULD NOT ADVANCE PROPERLY. HE PULLED BACK AND NOTED RIPPED STENT / STRUT STICKING OUT OF THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563991 ↗
• InjuryFeb 18, 2025Device Stenosis; Device Stenosis

  THE FOLLOWING WAS REPORTED TO GORE: TWO GORE® VIATORR® TIPS ENDOPROSTHESES WITH CONTROLLED EXPANSION WERE IMPLANTED FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE ON (B)(6) 2025. FOR UNKNOWN REASONS, THE PATIENT HAD PRESENTED WITH THROMBOSIS OF THE SUPERIOR MESENTERIC VEIN, PORTAL VEIN, AND SPLENIC VEIN. ON (B)(6) 2025, THE PATIENT UNDERWENT THROMBECTOMY FOR RECURRING SYMPTOMS. FOLLOWING THROMBECTOMY OF THE TWO VIATORR® DEVICES, ANOTHER GORE® VIATORR® TIPS ENDOPROSTHESES WITH CONTROLLED EXPANSION WAS IMPLANTED TO EXTEND TRACT COVERAGE TO THE INTERNAL VENA CAVA. THE CASE WAS COMPLETED SUCCESSFULLY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21404424 ↗
• InjuryFeb 18, 2025Device Stenosis; Device Stenosis

  THE FOLLOWING WAS REPORTED TO GORE: TWO GORE® VIATORR® TIPS ENDOPROSTHESES WITH CONTROLLED EXPANSION WERE IMPLANTED FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE ON (B)(6) 2025. FOR UNKNOWN REASONS, THE PATIENT HAD PRESENTED WITH THROMBOSIS OF THE SUPERIOR MESENTERIC VEIN, PORTAL VEIN, AND SPLENIC VEIN. ON (B)(6) 2025, THE PATIENT UNDERWENT THROMBECTOMY FOR RECURRING SYMPTOMS. FOLLOWING THROMBECTOMY OF THE TWO VIATORR® DEVICES, ANOTHER GORE® VIATORR® TIPS ENDOPROSTHESES WITH CONTROLLED EXPANSION WAS IMPLANTED TO EXTEND TRACT COVERAGE TO THE INTERNAL VENA CAVA. THE CASE WAS COMPLETED SUCCESSFULLY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21401143 ↗
• MalfunctionFeb 18, 2025Activation Failure; Material Split, Cut or Torn; Activation Failure; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PHYSICIAN SELECTED A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE TO REPAIR A PREVIOUS VIATORR® IMPLANT WHICH HAD THROMBOSED (IMPLANT DATE UNKNOWN). A DEVICE WAS PLACED, THE CHAIN-LINK PORTION OF THE STENT SUCCESSFULLY OPENED. HOWEVER, THE PHYSICIAN NOTED THAT THE TECHNICIAN MAY HAVE PULLED THE DEPLOYMENT LINE TOO AGGRESSIVELY, RESULTING IN THE STRING BREAKING JUST INSIDE THE HUB. THE PHYSICIAN ATTEMPTED TO GRASP THE TIP OF THE DEPLOYMENT LINE BUT WAS ONLY ABLE TO RETRIEVE FIBERS. IN AN EFFORT TO SECURE A BETTER HOLD, THE DELIVERY CATHETER WAS CUT OPEN, YET ONLY FIBERS COULD BE GRASPED. CONSEQUENTLY, THE ENTIRE DEVICE WAS REMOVED. ULTIMATELY A 10MM X 10CM GORE® VIABAHN® ENDOPROSTHESIS WAS PLACED TO RELINE THE TIPS WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394722 ↗
• MalfunctionJan 6, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A GORE® VIATOR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION. DURING DEVICE DEPLOYMENT, THE CHAIN LINK PORTION OPENED FINE, BUT THE COVERED PORTION ONLY OPENED ONE HALF TO THREE QUARTERS BEFORE IT GOT STUCK. THE PHYSICIAN SAID, "IT FELT LIKE THE DEPLOYMENT STRING HAD A KNOT IN IT AND I COULDN'T PULL ANY HARDER." THE DEVICE WAS REMOVED, AND A NEW VIATORR DEVICE WAS IMPLANTED SUCCESSFULLY. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078779 ↗
• InjuryNov 19, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION. PRIOR TO DEVICE EXPANSION, THE DEPLOYMENT STRING BROKE. THE CHAINLINK EXPANDED DEVICE WAS NOT ABLE TO BE RECAPTURED INTO THE SHEATH. IT WAS PULLED BACK UP INTO THE RIGHT JUGULAR VEIN AND A CUTDOWN WAS PERFORMED TO REMOVE THE DEVICE FROM THE PATIENT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Graft failure

  MAUDE report 20730054 ↗
• MalfunctionSep 17, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THE PHYSICIAN SELECTED A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION (VIATORR®) FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. DURING THE PROCEDURE THE DEVICE FAILED TO DEPLOY. REPORTEDLY, THE UNCOVERED PORTION OF THE DEVICE WAS UNCOVERED FROM THE SHEATH, AND WHEN THE DEPLOYMENT STRING WAS PULLED, THE DEVICE BOWED WITH TENSION AND WOULD NOT DEPLOY. IT APPEARED THE WIRE WAS KINKED AND HAD POSSIBLY LOST SOME OF ITS STRENGTH. AN AMPLATZER GUIDEWIRE WAS USED, SIZE NOT KNOWN. THE SHEATH INFORMATION IS UNKNOWN. ANOTHER VIATORR® OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE, WHICH THE PATIENT TOLERATED.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 20239614 ↗
• InjuryMay 13, 2024Device Stenosis; Device Stenosis

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE WHERE A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION (VIATORR DEVICE) WAS IMPLANTED. ON (B)(6) 2024, THE PATIENT UNDERWENT A REVISION PROCEDURE. IT WAS REPORTED THERE WAS VERY SUBTLE NARROWING OF THE VIATORR DEVICE AND THE PATIENT WAS NOT EXPERIENCING OPTIMAL OUTCOMES.

  Patient problems: Reduced Blood Flow

  MAUDE report 19298616 ↗
• MalfunctionMay 13, 2024Separation Failure; Activation Problem; Separation Failure; Activation Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION. DURING DEPLOYMENT, THE COVERED PORTION OF THE STENT ONLY PARTIALLY EXPANDED AND THEN THE DEPLOYMENT CORD WOULD NOT PULL ANY MORE. WHEN THE PHYSICIAN PULLED HARDER, THE CORD BROKE. A HIGH-PRESSURE BALLOON WAS USED TO TRY TO FINISH EXPANSION OF THE STENT BUT WAS UNSUCCESSFUL. THE CASE WAS ABORTED, WITH THE PATIENT IN STABLE CONDITION.

  Patient problems: Liver Damage/Dysfunction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297993 ↗
• MalfunctionJul 10, 2023Entrapment of Device; Fracture; Difficult to Remove; Entrapment of Device; Fracture; Difficult to Remove

  IT WAS REPORTED THE PHYSICIAN WAS DEPLOYING A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION. THE PHYSICIAN DID NOT PRE-DIALATE WITH A BALLOON. WHEN DEPLOYING APPROXIMATELY THE LAST CM OF THE COVERED SECTION, THE DEPLOYMENT CORD BROKE. WHILE MANIPULATING AND PULLING ON THE DELIVERY CATHETER, A PORTION OF THE DISTAL TIP BROKE OFF AND WAS RESTING IN THE PORTAL VEIN. THE PARTIALLY OPENED DEVICE AND TIP OF THE CATHETER REMAIN IN THE LIVER. THE PHYSICIAN WILL REASSESS THE PATIENT FOR ANOTHER ATTEMPT AT DEVICE PLACEMENT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 17289287 ↗
• InjuryMay 6, 2023Break; Break

  IT WAS REPORTED TO GORE A GORE® VIATORR® TIPS ENDOPROSTHESIS WAS IMPLANTED DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE ON (B)(6), 2022. IT WAS REPORTED IT IS UNCLEAR IF A WIRE WAS USED DURING DEPLOYMENT. IT WAS REPORTED THE DELIVERY CORD BROKE, CAUSE UNKNOWN. IT WAS REPORTED THAT ON AN UNKNOWN DATE, ULTRASOUND IDENTIFIED A PIECE OF CATHETER IN THE PATIENT. ON (B)(6), 2022 A TIPS REVISION TOOK PLACED AT WHICH TIME A PIECE OF THE CATHETER WAS REMOVED FROM THE PATIENT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 16883014 ↗
• MalfunctionOct 10, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION. AS THE DEVICE WAS HALF-WAY EXPANDED, THE DEPLOYMENT CORD BROKE. A SHEATH WAS ADVANCED TO THE DEVICE AND THE PHYSICIAN ATTEMPTED TO PULL THE DEVICE AND CATHETER INTO THE SHEATH. WHILE THE DEVICE WAS BEING PULLED INTO THE SHEATH, THE DISTAL PART OF THE CATHETER BROKE. A WIRE WAS ADVANCED FROM THE FEMORAL VEIN THROUGH THE DEVICE AND BACK OUT THE JUGULAR VEIN. THE DEVICE WAS PUSHED INTO THE VENA CAVA AND A SNARE WAS USED TO REMOVE THE HALF OF THE DEVICE AND A FORCEPS WAS USED TO REMOVE THE REMAINING HALF. A NEW VIATORR DEVICE WAS IMPLANTED, AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 15572845 ↗
• MalfunctionJun 22, 2022Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THE PHYSICIAN SELECTED A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION FOR A PRE-OPERATIVE TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) PRIOR TO COLON CANCER RESECTION. THE TRACT WAS PRE-DILATED AND THE BARE METAL STENT WAS DEPLOYED WITHOUT ISSUE. AFTER THE DEVICE WAS SITUATED, THE PHYSICIAN ATTEMPTED TO DEPLOY THE COVERED PORTION OF THE ENDOPROSTHESIS. FLUOROSCOPY SHOWED THAT THE STENT STARTED TO EXPAND; HOWEVER, THE DEPLOYMENT LINE BECAME STUCK AND THE LAST 2CM OF THE DEVICE IN THE HEPATIC VEIN DID NOT DEPLOY. THE DEPLOYMENT LINE WAS PULLED AGAIN BUT THE STENT WAS PULLED BACK INTO THE HEART. AT THIS POINT, THE PHYSICIAN UPSIZED TO A 16MM SHEATH AND ATTEMPTED TO RETRIEVE THE STENT WITH A SNARE. THIS ATTEMPT WAS UNSUCCESSFUL AND THE PHYSICIAN SWITCHED TO BIOPSY FORCEPS TO REMOVE THE DEVICE. THE STENT BEGAN TO UNRAVEL AND WAS REMOVED IN SEVERAL PIECES. THE ENTIRE STENT WAS REMOVED WITH NO ADVERSE EFFECT TO THE PATIENT. A SECOND GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION WAS THEN SUCCESSFULLY IMPLANTED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 14775201 ↗

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