GORE VIATORR TIPS Endoprosthesis PTB8108275Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00733132635047), received between Sep 28, 2018 and May 26, 2026 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 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 15 most recent of 15 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 19, 2021Device Dislodged or Dislocated; Activation Failure; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THE PHYSICIAN SELECTED A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. FOLLOWING DEVICE PLACEMENT, THE COVERED PORTION OF THE STENT DID NOT FULLY DEPLOY. STRONG RESISTANCE WAS MET WITH THE DEPLOYMENT LINE AND AS THE LINE WAS PULLED HARDER, THE DEVICE WAS PULLED FROM THE DESIRED POSITION. THE STENT WAS SNARED FROM THE PATIENT. TWO GORE® VIATORR® TIPS ENDOPROSTHESES WITH CONTROLLED EXPANSION WERE THEN IMPLANTED WITH NO ADVERSE EFFECTS. TO THE PATIENT. THE ACCOUNT REPORTED THAT THE VIATORR® DEVICE KINKED MAKING A SHARP TURN AND THAT THE KINK MAY HAVE LED TO THE DEPLOYMENT LINE BEING STUCK OR PINCHED WHEN DEPLOYMENT WAS ATTEMPTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188996 ↗
• InjuryMay 13, 2021Device Slipped; Use of Device Problem; Device Slipped; Use of Device Problem

  IT WAS REPORTED THE PHYSICIAN SELECTED A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. IT WAS FURTHER REPORTED THAT THE INTRODUCER SHEATH HAD MOVED INTO THE HEPATIC VEIN, AND THE PHYSICIAN UNINTENTIONALLY DEPLOYED THE CHAIN LINK WHEN UNSHEATHING. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE DEVICE INTO THE INTRODUCER SHEATH AND A VASCULAR SURGEON WAS CALLED TO REMOVE THE DEVICE VIA A CUT DOWN IN THE JUGULAR VEIN. A WALLSTENT WAS THEN USED TO COMPLETE THE PROCEDURE, AND THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820782 ↗
• MalfunctionMay 30, 2019Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THE PHYSICIAN SELECTED A GORE® VIATORR® TIPS ENDOPROSTHESIS FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. THE DEVICE WAS PLACED AND THE BARE METAL PORTION WAS DEPLOYED WITHOUT ISSUE. AFTER DEPLOYING APPROXIMATELY ONE THIRD OF COVERED PORTION OF THE STENT, THE DEPLOYMENT LINE BECAME STUCK. SEVERAL MANEUVERS WERE ATTEMPTED TO FULLY DEPLOY THE STENT; HOWEVER, THE DEPLOYMENT LINE EVENTUALLY BROKE. THE DELIVERY SYSTEM WAS REMOVED AND A BALLOON WAS ADVANCED INTO THE STENT TO ATTEMPT AND RELEASE THE REMAINING CONSTRAINED PORTION. FOLLOWING THIS PROCESS, THERE WERE TWO SECTIONS OF STENT THAT WERE NOT FULLY OPEN. THE PROCEDURE WAS CONCLUDED AND THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 8654241 ↗
• InjuryApr 5, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THE PHYSICIAN DEPLOYED A GORE® VIATORR® TIPS ENDOPROSTHESIS. THE PATIENT HAD PREEXISTING PORTAL VEIN THROMBOSIS. ONE DAY LATER, THE PHYSICIAN WAS PERFORMING A BALLOON THROMBECTOMY. DURING ONE OF THE PASSES, THE VIATORR® DEVICE WAS DISLODGED TO THE RIGHT ATRIUM. THE PHYSICIAN WAS ABLE TO PULL THE EXPANDED DEVICE OUT THROUGH THE INTERNAL JUGULAR, WHICH ENLARGED THE ACCESS SITE. A 16 FR SHEATH WITH A SUTURE AROUND IT WAS USED TO ACHIEVE HEMOSTASIS. A VASCULAR SURGEON CLOSED THE ACCESS SITE ONCE THE PROCEDURE WAS FINISHED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Skin Tears

  MAUDE report 8489480 ↗
• InjurySep 28, 2018Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS). ABOUT A THIRD OF THE GRAFT LINED REGION WAS DEPLOYED NORMALLY WHEN THE LINE BROKE. IT IS UNKNOWN TO GORE IF IT WAS STUCK AT THIS POINT. THE PHYSICIAN DISSECTED THE CATHETER TO TRY AND GRAB THE REMAINING DEPLOYMENT LINE WITH A HEMOSTAT, BUT THE LINE KEPT "SHREDDING" SO THE PHYSICIAN WAS UNABLE TO DEPLOY THE REMAINDER OF THE GRAFT LINED REGION. IT IS UNKNOWN TO GORE IF INABILITY TO CONTINUE DEPLOYMENT WAS DUE TO "SHREDDING" OR DUE TO THE LINE BEING STUCK. THE PHYSICIAN WAS ABLE TO REMOVE THE CATHETER, AND CONCLUDED THE PROCEDURE WITH THE VIATORR STILL CONSTRAINED ALONG THE PROXIMAL 2/3 OF GRAFT LINED REGION DUE TO MAXIMUM FLUORO TIME BEING REACHED. IT WAS THEN REPORTED TO GORE FROM THE PHYSICIAN, "FOLLOW UP CT SHOWS RELEASE STRING IN RIGHT ATRIUM TRACKING UP TO SVC." A REVIEW BY GORE OF IMAGES AND THE REMAINING CATHETER PIECES SUGGEST THAT THE DISTAL END OF THE CATHETER BROKE OFF FROM THE REST OF THE CATHETER AND REMAINS IN THE PATIENT DUE TO THIS PIECE MISSING FROM THE CATHETER SPECIMEN THAT WAS RETRIEVED. THIS IS WHA

  Patient problems: Occlusion

  MAUDE report 7918987 ↗