GORE VIATORR TIPS Endoprosthesis PTB8107275Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132635030), received between May 6, 2020 and Jun 22, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 30, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION ON (B)(6) 2021. ON (B)(6) 2021 A LIKELY OCCLUSION OF THE DEVICE WAS NOTED. ON (B)(6) 2021 A REVISION OCCURED TO CLEAR AN OCCLUSION AT THE PORTAL VENOUS END OF THE STENT, NEAR THE JUNCTION OF THE CHAIN LINK AND COVERED PORTION. AN ANGIOJET WAS USED TO DE-CLOT, THEN THE LESION WAS BALLOONED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12554544 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION WAS IMPLANTED (B)(6) 2020 DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. A REVISION PROCEDURE USING A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION WAS PERFORMED ON (B)(6) 2020 IN AN ATTEMPT TO NARROW THE TIPS LUMEN DUE TO PERSISTENT HEPATIC ENCEPHALOPATHY. IT WAS REPORTED THAT THE GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION STENT THAT WAS PREVIOUSLY PLACED HAD BEEN DILATED TO 10MM WHEN PLACED. THE PHYSICIAN PERFORMING THE REVISION PROCEDURE DEPLOYED THE GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION IN THE EXPECTATION THAT IT WOULD ONLY EXPAND TO 8MM, HOWEVER; THE STENT DEPLOYED TO 9.8MM AND DID NOT PRODUCE THE NARROWED LUMEN THAT WAS DESIRED FOR THE PROCEDURE. THE PHYSICIAN WAS SUCCESSFUL IN REDUCING THE DIAMETER OF THE TIPS AFTER PLACING A THIRD GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION WITH A BALLOON EXPANDABLE STENT BETWEEN IT AND THE SECOND ONE. THE PATIENT DID WELL CLINICALLY.

  Patient problems: Encephalopathy

  MAUDE report 10028495 ↗