GORE VIABAHN Endoprosthesis with Heparin VBHR131002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132646142), received between Jun 3, 2021 and Aug 25, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2023Accessory Incompatible; Adverse Event Without Identified Device or Use Problem; Accessory Incompatible; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2023, A PATIENT PRESENTED WITH IN-STENT RESTENOSIS FROM THE COMMON FEMORAL ARTERY TO EXTERNAL ILIAC ARTERY. AS REPORTED, THIS PATIENT HAD BEEN DEEMED UNSUITABLE FOR SURGICAL INTERVENTION. CONSEQUENTLY, THE PHYSICIAN REPORTEDLY ELECTED TO TREAT THE STENOTIC LESION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). AN 8MM BALLOON (BRAND UNKNOWN) WAS FIRST USED THROUGH A 6FR SHEATH (BRAND UNKNOWN). THE BALLOON WAS THEN SWITCHED TO A 10MM BALLOON. WHILE USING THE 10MM BALLOON, THE EXTERNAL ILIAC ARTERY REPORTEDLY RUPTURED. TO TREAT THE RUPTURE, A 13MM X 10CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS SELECTED. THE 6FR INTRODUCER SHEATH WAS SWITCHED OUT TO A 10FR COOK® FLEXOR® CHECK-FLO® SHEATH WITH A TOUHY VALVE (POSSIBLY 45 CM LENGTH). REPORTEDLY, DUE TO THE URGENT SITUATION, THE VIABAHN DEVICE CARTON LABEL AND IFU INDICATING INCAPABILITY WITH 10 COOK® FLEXOR® CHECK-FLO® SHEATH WAS MISSED BY THE HOSPITAL STAFF. THE VIABAHN DEVICE REPORTEDLY BECAME STUCK AS IT WAS UNABLE TO FIT THROUGH THE SHEATH. THE CONSTRAINED VIABAHN DEVICE WAS WITHDRAWN, AND THE SHEATH WAS EXCHANGED FROM THE 10FR TO A

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Vascular Dissection

  MAUDE report 17628338 ↗
• InjuryFeb 7, 2023Migration; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE BY THE FIELD SALES ASSOCIATE: ON AN UNKNOWN DATE, TWO 13MM X 10CM GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WERE REPORTEDLY IMPLANTED IN THE ILIAC VEIN FOR TREATMENT OF ARTERIOVENOUS MALFORMATION (AVM). IT WAS REPORTED TWO WALLSTENT¿ ENDOPROSTHESIS - BOSTON SCIENTIFIC DEVICES (18MM) WERE ALSO IMPLANTED TO TREAT AVM. IT WAS ALSO REPORTED THERE WAS NOT A GORE FIELD SALES ASSOCIATE PRESENT DURING THE PROCEDURE TO PROVIDE CLINICAL SUPPORT. IT WAS REPORTED, ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR UNKNOWN REASON. IT WAS REPORTED, ON AN UNKNOWN DATE, IT WAS IDENTIFIED THAT ALL FOUR DEVICES HAD MIGRATED FROM THE ILIAC VEIN INTO THE HEART. THE PHYSICIANS REPORTED SUSPECTED CAUSE OF THE DEVICES MIGRATING WERE DUE TO INCORRECT DEVICE SIZING FOR THE ANATOMICAL LOCATION DURING THE INITIAL PROCEDURE. IT WAS REPORTED, ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN OPEN PROCEDURE TO EXPLANT THE FOUR DEVICE THAT MIGRATED INTO THE HEART. ALL FOUR DEVICE WERE REPORTED TO HAVE BEEN SUCCESSFULLY EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 16312307 ↗
• InjuryFeb 7, 2023Migration; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE BY THE FIELD SALES ASSOCIATE: ON AN UNKNOWN DATE, TWO 13MM X 10CM GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WERE REPORTEDLY IMPLANTED IN THE ILIAC VEIN FOR TREATMENT OF ARTERIOVENOUS MALFORMATION (AVM). IT WAS REPORTED TWO WALLSTENT¿ ENDOPROSTHESIS - BOSTON SCIENTIFIC DEVICES (18MM) WERE ALSO IMPLANTED TO TREAT AVM. IT WAS ALSO REPORTED THERE WAS NOT A GORE FIELD SALES ASSOCIATE PRESENT DURING THE PROCEDURE TO PROVIDE CLINICAL SUPPORT. IT WAS REPORTED, ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR UNKNOWN REASON. IT WAS REPORTED, ON AN UNKNOWN DATE, IT WAS IDENTIFIED THAT ALL FOUR DEVICES HAD MIGRATED FROM THE ILIAC VEIN INTO THE HEART. THE PHYSICIANS REPORTED SUSPECTED CAUSE OF THE DEVICES MIGRATING WERE DUE TO INCORRECT DEVICE SIZING FOR THE ANATOMICAL LOCATION DURING THE INITIAL PROCEDURE. IT WAS REPORTED, ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN OPEN PROCEDURE TO EXPLANT THE FOUR DEVICE THAT MIGRATED INTO THE HEART. ALL FOUR DEVICE WERE REPORTED TO HAVE BEEN SUCCESSFULLY EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 16312120 ↗
• MalfunctionJun 3, 2021Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT PRESENTED WITH AN ANEURYSM IN THE COMMON ILIAC ARTERY AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX). THE PHYSICIAN ADVANCED THE VSX DEVICE TO THE TREATMENT ZONE AND INITIATED DEPLOYMENT. UPON INITIATING DEPLOYMENT, THE PHYSICIAN MET RESISTANCE PULLING THE DEPLOYMENT LINE AND COMPLETE DEVICE EXPANSION COULD NOT BE ACHIEVED. THE PHYSICIAN DECIDED TO REMOVE THE PARTIALLY DEPLOYED VSX DEVICE BY REMOVING THE WIRE, DEVICE, AND SHEATH ALL AT THE SAME TIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER GORE DEVICE. THE PATIENT TOLERATED THE PROCEDURE. PATIENT INFORMATION WAS REQUESTED BUT WILL NOT BE MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11934771 ↗