GORE VIABIL Biliary Endoprosthesis VN0806200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132615599), received between Apr 11, 2019 and Sep 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K081184); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2019Material Twisted/Bent

  STENT MALFUNCTION DURING PROCEDURE. BENT AT THE DISTAL TIP UPON DEPLOYMENT. HAD TO PLACE ANOTHER STENT. PROCEDURE IN DETAIL: THERAPEUTIC GASTROSCOPE WAS ADVANCED FROM ESOPHAGUS TO THE STOMACH. FLUID WAS SUCTIONED OUT FROM STOMACH. THE GASTROSCOPE WAS ADVANCED FROM THE PYLORUS TO THE BULB, WHERE POST BULBAR DUODENAL STRICTURE WAS NOTED. WE COULD NOT ADVANCE THE GASTROSCOPE BEYOND THE STRICTURE. A RETRIEVAL BALLOON WITH PRELOADED GUIDEWIRE WAS ADVANCED THROUGH THE STRICTURE. A NASODUODENAL TUBE WAS ADVANCED OVER THE GUIDEWIRE WITH A DISTAL END IN THE PROXIMAL JEJUNUM. THE GASTROSCOPE WAS REMOVED AND A LINEAR ECHOENDOSCOPE WAS ADVANCED TO THE STOMACH. CONTRAST WAS INJECTED TO ASSESS THE PLACEMENT. LARGE AMOUNT OF WATER MIXED WITH METHYLENE BLUE WAS USED TO DISTEND THE SMALL BOWEL. 1 MG OF IV GLUCAGON WAS GIVEN TO DECREASE SMALL BOWEL MOTILITY. THERE WAS SIGNIFICANT AMOUNT OF ASCITES NOTED AROUND THE LIVER AND SMALL BOWEL. WE COULD NOT FIND A SAFE WINDOW TO PERFORM AN EUS GASTROJEJUNOSTOMY AS THE LUMEN OF THE SMALL BOWEL WAS AT LEAST ~20 MM AWAY FROM THE GASTRIC WALL. THE PLAN FOR GASTROJEJUNOSTOMY WAS ABORTED. THE LINEAR EUS SCOPE WAS REMOVED ALONG WITH THE NASODUODENAL TUBE. THE THER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9081542 ↗
• MalfunctionApr 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE BY CONMED (REC# (B)(4)) THAT AN ERCP PROCEDURE WAS PERFORMED USING GORE® VIABIL® BILIARY ENDOPROSTHESIS (VN0806200). IT WAS REPORTED THE PROXIMAL END OF STENT FRAYED DURING ATTEMPTED REMOVAL OF INDWELLING STENT. MULTIPLE UNSUCCESSFUL ATTEMPTS TO REMOVE THE STENT WERE MADE, EACH RESULTED IN FURTHER NUMEROUS ENDS OF WIRES PROTRUDING IN DUODENUM FROM AMPULLA. IT WAS REPORTED THEY WERE NOT UNABLE TO CLEAR THE DEBRIS FROM THE STENT OR TO REMOVE STENT. IT WAS REPORTED THAT A SMALLER FRENCH PLASTIC STENT WAS PLACED INSIDE REMAINING STENT TO FACILITATE DRAINAGE. REPORTEDLY, NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED AND THERE WAS NO INJURY TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE PATIENT IS TO BE MONITORED ON OUTPATIENT BASIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8506342 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081184. One submission often covers many models, so check the product and lot details in each record.

• Z-1593-2021 · Apr 5, 2021 · Terminated
  GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for pa