GORE VIABAHN Endoprosthesis VBC101002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132623617), received between Sep 4, 2018 and Apr 16, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (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.

• MalfunctionApr 16, 2021Activation Problem; Activation Problem

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A BRACHIO-BASILIC ARTERIOVENOUS FISTULA IN THE PATIENT'S RIGHT ARM, ANGIOPLASTY WAS PERFORMED DUE TO STENOSIS. THE GORE® VIABAHN® ENDOPROSTHESIS WAS THEN PLACED AT THE TREATMENT SITE. DEPLOYMENT WAS STARTED AND AS THE DEPLOYMENT LINE WAS PULLED, THE PHYSICIAN STATED THE DEPLOYMENT LINE GOT CAUGHT ON SOMETHING AND WOULD NOT RELEASE. THE DEVICE DID NOT EXPAND AT THE INTENDED LOCATION OF THE STENOSIS. WHEN THE DEVICE WAS BEING REMOVED OVER THE WIRE THE DEVICE STARTED EXPANDING WITHOUT THE DEPLOYMENT LINE BEING PULLED. THE EXPANDED DEVICE WAS REMOVED BY HAND AS IT WAS AT OR NEAR THE ACCESS SITE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH GOOD RESULTS AND NO ADVERSE OUTCOME FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682752 ↗
• MalfunctionNov 15, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE BY THE DOCTOR: THE DEPLOYMENT LINE OF THE GORE® VIABAHN® ENDOPROSTHESIS COULD NOT BE REMOVED FROM THE PATIENT AND WAS LEFT IN THE PATIENT. THE GORE® VIABAHN® ENDOPROSTHESIS WAS SUCCESSFULLY IMPLANTED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8075802 ↗
• MalfunctionSep 4, 2018Separation Failure; Separation Failure

  THE FOLLOWING WAS REPORTED TO GORE: THE PHYSICIAN WAS PERFORMING AN AV ACCESS MAINTENANCE PROCEDURE. A 10X10 GORE® VIABAHN® ENDOPROSTHESIS WAS SELECTED TO BE PLACED IN THE SUBCLAVIAN VEIN. THE TECH SAID THE PHYSICIAN BEGAN PULLING THE DEPLOYMENT LINE TO DEPLOY THE VIABAHN BUT IT STOPPED BEFORE THE STENT WAS FULLY DEPLOYED. THE PHYSICIAN DESCRIBED THE DEPLOYMENT LINE AS THOUGH IT WAS HUNG UP OR CAUGHT ON SOMETHING. SOMEHOW THE PHYSICIAN WAS ABLE TO FULLY DEPLOY THE GORE® VIABAHN® ENDOPROSTHESIS BUT WAS UNABLE TO REMOVE ALL THE DEPLOYMENT LINE. ONCE THE CATHETER WAS REMOVED, THE DEPLOYMENT LINE WAS CUT AT THE SKIN LEVEL AND THE REST OF THE DEPLOYMENT LINE WAS LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7842939 ↗