GORE VIABAHN Endoprosthesis VBC070502Recalls & reported problems
W. L. Gore & Associates, Inc. · Class 3 · Implant
All models of GORE VIABAHN Endoprosthesis (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132614516), received between Sep 19, 2018 and Sep 19, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Activation Failure” (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
Device problems
- Activation Failure1
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
- Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2018Material Fragmentation; Activation Failure; Material Fragmentation; Activation Failure
IT WAS REPORTED TO GORE DURING A PROCEDURE FOR TREATMENT OF THE ABDOMINAL AORTIC ANEURYSM A 6MM X 5CM GORE® VIABAHN® ENDOPROTHESIS WAS TO BE IMPLANTED AS A BRANCH GRAFT IN THE LEFT RENAL ARTERY BY A FENESTRATION TECHNIQUE. AFTER THE VIABAHN® DEVICE WAS ADVANCED THROUGH A COOK LONG SHEATH TO THE TARGET LESION INSIDE THE LEFT RENAL ARTERY, THE DEPLOYMENT WAS INITIATED. NO RESISTANCE WAS FELT DURING PULLING THE DEPLOYMENT LINE. BUT THE EXPANSION OF DEVICE REPORTEDLY STARTED FROM THE MIDDLE THEN WENT TO THE DISTAL PART, THERE STILL APPROXIMAL 2CM PROXIMAL OF STENT WAS NOT EXPANDED EVEN AFTER THE DEPLOYMENT LINE WAS PULLED OUT COMPLETELY. THE PHYSICIAN HAD TO PULL THE CATHETER WITH EXTRA FORCE OUT OF THE PATIENT, AFTER THE CATHETER WAS REMOVED OUT, THE DISTAL SHAFT WAS OBSERVED BEING BROKEN WITHOUT A DISTAL TIP, WHICH WAS SEPARATED AND LEFT INSIDE THE PATIENT. THE LEFT RENAL ARTERY WAS REPORTEDLY OCCLUDED. THE PROCEDURE WAS ENDED WITHOUT FURTHER TREATMENT. ACCORDING TO THE PHYSICIAN, THE PATIENT EXPERIENCED A CANCER OF COLON WITH INVASION OF THE LEFT KIDNEY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN CONCERNED A QUALITY ISSUE OF THE VIABAHN® DEVICE AND REQUESTED AN INVESTIGATION
Patient problems: Device Embedded In Tissue or Plaque; Occlusion
MAUDE report 7888381 ↗
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- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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