GORE VIABAHN Endoprosthesis with Heparin VBH090502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132623174), received between Oct 28, 2018 and Oct 28, 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2018Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING A TRANS FEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT. FOLLOWING PLACEMENT OF THE AORTIC VALVE DEVICE, A PERFORATION OF THE RIGHT COMMON FEMORAL ARTERY WAS RECOGNIZED. A GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED OVER A WHOLEY WIRE THROUGH A 9FR. PINNACLE SHEATH. WHEN DEPLOYMENT WAS ATTEMPTED, THE DEVICE ONLY PARTIALLY EXPANDED. THE DISTAL MOST ASPECT OF THE DEVICE (3-4MM) DID NOT EXPAND. THE DEPLOYMENT LINE WAS PULLED HARD TO TRY TO GET THE DEVICE TO COMPLETELY EXPAND. THE DEPLOYMENT LINE EVENTUALLY BROKE. IT WAS NOT POSSIBLE TO REMOVE THE CATHETER AND THE PARTIALLY DEPLOYED DEVICE. THE PROCEDURE WAS CONVERTED TO OPEN REPAIR FOR STENT REMOVAL WHILE THE CATHETER WAS STILL IN PLACE. THE STENT AND CATHETER WERE REMOVED SURGICALLY AND THE ARTERY WAS ALSO REPAIRED SURGICALLY. LATER IN THE NIGHT THE PATIENT HAD A PERIPHERAL EMBOLIZATION REQUIRING THROMBECTOMY OF THE RIGHT POPLITEAL ANTERIOR TIBIAL/POSTERIOR TIBIAL ARTERIES AND A FOUR-COMPARTMENT FASCIOTOMY OF THE RIGHT CALF. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT.

  Patient problems: Thromboembolism

  MAUDE report 8011360 ↗