GORE VIATORR TIPS Endoprosthesis PTB8106275Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132635023), received between Jun 20, 2019 and Jul 22, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJul 27, 2021Activation Failure; Activation Failure

  THE PHYSICIAN WAS PERFORMING A TIPS PROCEDURE USING A 10 FR COOK INTRODUCER SHEATH AND A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY DEPLOY THE UNLINED, CHAIN-LINK PORTION OF THE DEVICE IN THE PORTAL VEIN AND BEGAN TO DEPLOY THE GRAFT-LINED REGION OF THE DEVICE. THE PHYSICIAN REPORTED THAT APPROXIMATELY HALF-WAY THROUGH PULLING THE DEPLOYMENT LINE THAT IT STOPPED AND FELT ¿LOCKED¿. THE PHYSICIAN REPORTED THAT HE CONTINUED TO APPLY SUCH FORCE TO ATTEMPT DEPLOYMENT THAT THE AMPLATZ GUIDEWIRE KINKED. THE PHYSICIAN THEN EXCHANGED FOR A NEW AMPLATZ GUIDEWIRE, AND CONTINUED TO ATTEMPT FULL DEPLOYMENT, WHICH REMAINED UNSUCCESSFUL. THE PHYSICIAN REPORTED THAT HE THEN ATTEMPTED TO RE-SHEATH THE PARTIALLY DEPLOYED DEVICE BUT WAS UNSUCCESSFUL. THE PHYSICIAN CUT THE BACK END OF THE DELIVERY CATHETER OFF TO REMOVE THE 10 FR COOK INTRODUCER SHEATH AND UPSIZED TO A 12 FR COOK INTRODUCER SHEATH, TO REMOVE THE DEVICE THROUGH THE LARGER SHEATH. IT WAS REPORTED THAT THE PHYSICIAN STILL WAS NOT ABLE TO COMPLETELY RE-SHEATH THE DEVICE FOR REMOVAL. THE PHYSICIAN THEN INSERTED A SNARE CATHETER TO CAPTURE THE DEVICE AND WAS ABLE TO SUCCESSFULLY REMO

  Patient problems: Failure of Implant

  MAUDE report 12227650 ↗
• MalfunctionOct 27, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THE PHYSICIAN ADVANCED A GORE® VIATORR® TIPS ENDOPROSTHESIS TO THE LIVER. DURING DEPLOYMENT, THE ENDOPROSTHESIS ONLY DEPLOYED ABOUT HALF-WAY WHEN IT WAS NOT POSSIBLE TO OPEN ANYMORE. THE PHYSICIAN WAS ABLE TO PULL IT INTO THE CATHETER AND REMOVE THE DEVICE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10741353 ↗
• InjuryJun 20, 2019Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED THE PHYSICIAN SELECTED A GORE® VIATORR® TIPS ENDOPROSTHESIS FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. THE DEVICE WAS PLACED WITHOUT ISSUE. AFTER THE PHYSICIAN RETRACTED THE SHEATH AND PULLED THE DEPLOYMENT LINE, THE LINED PORTION OF THE STENT DID NOT DEPLOY. THE PHYSICIAN ATTEMPTED TO BALLOON THE STENT, BUT WAS NOT SUCCESSFUL. THE PHYSICIAN THEN DECIDED TO REMOVE THE DEVICE; HOWEVER, IT WAS VERY DIFFICULT TO RETRACT AND A SURGEON WAS CALLED TO PERFORM A CUT-DOWN OF THE INTRODUCTION SITE IN ORDER TO REMOVE THE DEVICE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE AND ANOTHER TIPS CASE IS SCHEDULED.

  Patient problems: Occlusion

  MAUDE report 8717116 ↗