GORE VIABAHN Endoprosthesis with Heparin VBHR080702ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132624065), received between Sep 25, 2018 and Jul 15, 2024 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionJul 15, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024 THE PATIENT UNDERWENT TREATMENT FOR AN ANEURYSM IN THE SPLENIC ARTERY WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT THE PHYSICIAN USED AN 8X7.5 VIABAHN DEVICE WITH 8FR COOK FLEXOR® ANSEL GUIDING SHEATH AND A BOSTON SCIENTIFIC AMPLATZ GUIDEWIRE. THE PHYSICIAN WAS ABLE TO REACH THE TARGET TREATMENT AREA AND WAS READY TO INITIATE DEPLOYMENT. WHILE DEPLOYING THE VIABAHN DEVICE, THE GUIDEWIRE CAME BACK WHILE THE VIABAHN DEVICE WAS 20% WAS DEPLOYED WHILE THE REMAINDER WAS CONSTRAINED INSIDE THE SHEATH. THE VIABAHN DEVICE NO LONGER HAD A WIRE RUNNING THROUGH IT. THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE GUIDEWIRE THROUGH THE VIABAHN DEVICE BUT WAS UNSUCCESSFUL. THE VIABAHN DEVICE WAS REMOVED FROM THE PATIENT IN TANDEM WITH THE SHEATH. THE PROCEDURE WAS COMPLETED BY COILING THE ANEURYSMAL SAC. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747029 ↗
• MalfunctionJan 30, 2024Activation Failure; Activation Failure

  ON (B)(6) 2023, A PATIENT UNDERWENT A FENESTRATED AORTIC ABDOMINAL ANEURYSM PROCEDURE WHERE AN 8 MM X 7.5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS USED IN THE LEFT RENAL ARTERY. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT VIA THE LEFT GROIN USING A 22F GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE VIABAHN® DEVICE DELIVERY CATHETER WAS THEN ADVANCED INSIDE THAT SHEATH THROUGH A 12F TERUMO NAGARE BIDIRECTIONAL STEERABLE SHEATH OVER AN UNKNOWN SIZE STIFF GUIDE WIRE TO THE TARGET TREATMENT SITE. REPORTEDLY, THE ANATOMY WAS TORTUOUS AND THE DELIVERY CATHETER HAD TO TRAVEL A LONG DISTANCE AND THROUGH OTHER DEVICES TO THE TARGET TREATMENT ZONE. IN AN ATTEMPT TO DEPLOY THE ENDOPROSTHESIS, THE LINE WAS PULLED AND BROKE MAKING A LOUD SOUND. THE DELIVERY SYSTEM CATHETER, DEPLOYMENT LINE AND SHEATH WERE WITHDRAWN FROM THE PATIENT. THE ENDOPROSTHESIS WAS REMOVED WITH PARTIAL DISTAL EXPANSION, BUT THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THE PHYSICIAN DOES NOT KNOW WHY THE DEPLOYMENT LINE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT VIABAHN® DEVICE. IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608671 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR A THORACIC CASE. THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN WAS PLACED IN THE LEFT EXTERIOR ILIAC TO THE COMMON ILIAC TO BE A CONDUIT FOR THE ADVANCEMENT OF THE COOK DEVICE. THE DOCTOR REPORTED THE VESSEL WAS VERY TORTUOUS. NEXT A COOK ALPHA 34-113 (18FR-7.1MM) DEVICE WAS ADVANCED TO THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN. ATTEMPTS TO ADVANCE THE COOK DEVICE THROUGH THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN WERE UNSUCCESSFUL. DURING ADVANCEMENT IT APPEARED THAT THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN 'ACCORDIONED'. THE COOK DEVICE WAS WITHDRAWN AND THE DOCTOR OBSERVED THAT THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN WAS ATTACHED TO IT. THE ABSENCE OF THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN CREATED AN ILIAC RUPTURE. CONTROL OF THE RUPTURE WAS ACHIEVED WITH A CODA BALLOON. THE ILIAC WAS REPAIRED USING MULTIPLE ENDOVASCULAR DEVICES AND THE THORACIC PROCEDURE WAS COMPLETED. THE DOCTOR REPORTED TO GORE THAT THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7906261 ↗