GORE VIABAHN Endoprosthesis with Heparin VBH091502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132623198), received between Sep 6, 2018 and Aug 6, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2020Break; Material Integrity Problem; Material Integrity Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT UNDERWENT TREATMENT OF A POPLITEAL ANEURYSM USING GORE® VIABAHN® ENDOPROSTHESIS. DURING DEPLOYMENT OF THE VIABAHN THE DEPLOYMENT LINE BROKE LEAVING A PORTION OF THE DEVICE CONSTRAINED. IT WAS REPORTED AS THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT THE STENT GRAFT COMPLETELY EXPANDED. HOWEVER, A PORTION OF THE DEPLOYMENT LINE WAS LEFT IN THE PATIENT. THE PHYSICIAN STATED THE SUSPECTED CAUSE OF THE DEPLOYMENT LINE BREAK IS UNKNOWN. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10374625 ↗
• InjurySep 6, 2018Complete Blockage; Off-Label Use; Complete Blockage; Off-Label Use

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2018, A PATIENT WAS TREATED FOR A LEFT LEG POPLITEAL ARTERY ANEURYSM USING TWO GORE® VIABAHN® ENDOPROSTHESES WITH HEPARIN BIOACTIVE SURFACE. THE PATIENT REPORTED HIS LEG FELT BETTER FOR A PERIOD OF TIME AFTER THE (B)(6)PROCEDURE, BUT HIS LEG DID NOT IMPROVE AS HE HAD HOPED. IT WAS REPORTED THE SWELLING IN THE PATIENT¿S LEFT LEG DID NOT DECREASE, AND HE EXPERIENCED A FAIR AMOUNT OF DISCOMFORT THAT VARIED DAY BY DAY. THE PATIENT REPORTED THAT ON (B)(6) 2018, HE PRESENTED TO HIS LOCAL EMERGENCY ROOM WITH LEG DISCOLORATION, INTENSE CRAMPING, AND PAIN IN HIS LEFT LEG, AND IT WAS REPORTEDLY DETERMINED THERE WAS NO CIRCULATION BELOW THE PATIENT¿S LEFT KNEE. IT WAS FURTHER REPORTED THAT IMAGING SHOWED THE TWO GORE® VIABAHN® ENDOPROSTHESES WERE OCCLUDED. ACCORDING TO THE REPORT, THE HOSPITAL EMERGENTLY TRANSFERRED THE PATIENT VIA AIR EVACUATION TO INDIANA UNIVERSITY HEALTH METHODIST HOSPITAL, WHERE THE PATIENT WAS ADMITTED FOR TREATMENT OF THE OCCLUSION. IT WAS REPORTED TO THE PATIENT THAT A RADIOLOGIST ATTENDING TO THE PATIENT DURING HIS (B)(6) 2018 VISIT STATED HIS STENTS DID NOT OCCLUDE ALL AT ONCE, AND THAT THE OCCLUSION WAS A GRADUAL PROCESS. IT W

  Patient problems: Cramp(s); Ischemia; Numbness; Pain; Skin Discoloration

  MAUDE report 7853989 ↗