GORE VIABAHN Endoprosthesis with Heparin VBJR050702ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132624089), received between Jun 12, 2019 and Feb 23, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2024Break; Activation Failure; Break; Activation Failure

  ON JANUARY 30, 2024, A PATIENT UNDERWENT DISTAL VEIN ARTERIALIZATION (DVA) TREATMENT FOR CHRONIC LIMB THREATENING ISCHEMIA (CLTI) USING A 5 MM X 7.5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) IN A NATIVE PERIPHERAL ARTERIOVENOUS FISTULA IN THE FOOT. IT WAS REPORTED THE PHYSICIAN ADVANCED A VIABAHN® DEVICE ANTEGRADE DOWN THE POPLITEAL ARTERY. THIS ENDOPROSTHESIS DEPLOYED WITHOUT INCIDENCE. A SECOND ENDOPROSTHESIS WAS ADVANCED VIA PEDAL ACCESS AROUND THE HEAL AND UP THROUGH THE PLANTAR VEIN USING A TERUMO 5F - 6F (OUTER AND INNER DIAMETERS RESPECTIVELY) GLIDESHEATH SLENDER® HYDROPHILIC COATED INTRODUCER SHEATH OVER AN 0.018" V-18¿ CONTROLWIRE¿ GUIDEWIRE. REPORTEDLY, DURING DEPLOYMENT, THE LINE WAS PULLED AND THE DEPLOYMENT LINE BROKE AND THE ENDOPROSTHESIS PARTIALLY DEPLOYED. ON ONE IMAGE POINT IT APPEARED THE ENDOPROSTHESIS EXPANDED HUB TO TIP, WITH THE DISTAL PORTION REMAINING CONSTRAINED. HOWEVER, THE PROGRESSION OF EXPANSION WAS NOT OBSERVED UNDER FLUOROSCOPY. AN ADDITIONAL WIRE WAS ADVANCED AND A BALLOON WAS USED TO POP THE ENDOPROSTHESIS OPEN. DURING WITHDRAWAL IT WAS DIFFICULT TO GET THE OLIVE TIP OUT, BUT EVENTUALLY IT WAS WIGGLED FREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767707 ↗
• InjuryApr 25, 2022Break; Entrapment of Device; Malposition of Device; Device Damaged by Another Device; Break; Entrapment of Device; Malposition of Device; Device Damaged by Another Device

  IT WAS REPORTED TO GORE THAT DURING A IN STENT RESTENOSIS (ISR) PROCEDURE THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS UNABLE TO BE DEPLOYED DUE TO DEPLOYMENT LINE BREAK. REPORTEDLY THE PHYSICIAN WAS UNABLE TO PULL THE DEVICE BACK INTO THE SHEATH NOR WERE THEY ABLE TO REMOVE THE DEVICE FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO A LOCAL HOSPITAL TO REMOVE THE DEVICE. REPORTEDLY PATIENT STATUS IS UNKNOWN AT THIS TIME NOR THE OUTCOME OF THE PROCEDURE. PER THE FSA, PATIENT WAS TRANSPORTED TO LOCAL HOSPITAL ((B)(6) HOSPITAL CENTER). UPON WHICH THE SURGEON OBSERVED THAT THE UNDEPLOYED GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT WAS CAUGHT ON THE ORIGINAL STENT STRUT (MANUFACTURER UNKNOWN), THIS WAS WHY THE STENT WAS UNABLE TO BE REMOVED WHEN DEPLOYMENT FAILED. REPORTEDLY ONCE VSX WAS PULLED FREE, THE VSX DEPLOYED AND WAS REMOVED SUCCESSFULLY. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER GORE VSX DEVICE AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196894 ↗
• InjuryApr 22, 2021No Flow; No Flow

  'OUTCOMES OF SMALL RENAL ARTERY TARGETS IN PATIENTS TREATED BY FENESTRATED- BRANCHED ENDOVASCULAR AORTIC REPAIR' JUSSI M. KÄRKKÄINEN, EMANUEL R. TENORIO, KEOUNA PATHER, BERNARDO C. MENDES, THANILA A. MACEDO, JEAN WIGHAM, ALISA DIDERRICH, GUSTAVO S. ODERICH. THE AIM WAS TO EVALUATE RENAL RELATED OUTCOMES IN PATIENTS WHO HAD INCORPORATION OF A SMALL (<4.0 MM) RENAL ARTERY (RA) DURING FENESTRATED-BRANCHED ENDOVASCULAR AORTIC REPAIR (F-BEVAR). A TOTAL OF 215 CONSECUTIVE PATIENTS ENROLLED IN A PROSPECTIVE F-BEVAR TRIAL WERE REVIEWED. THE KAPLANE-MEIER ESTIMATES OF ONE AND TWO YEAR RA RELATED OUTCOMES ARE PRESENTED IN TABLE 4. AT ONE YEAR, PRIMARY PATENCY WAS 79 ± 9% IN THE STUDY GROUP AND 94 ± 1% IN THE CONTROL GROUP (P < .001); SECONDARY PATENCY WAS 84 ± 8% VS. 97 ± 1% (P < .001), RESPECTIVELY (FIG. 3A). FREEDOM FROM RA INSTABILITY WAS 79 ± 9% VS. 93 ± 2% AT ONE YEAR (P ¼ .005, FIG. 3B), AND FREEDOM FROM RENAL FUNCTION DETERIORATION WAS 90 ± 7% VS. 90 ± 3% (P ¼ .09), RESPECTIVELY. THERE WERE NO DIFFERENCES IN FREEDOM FROM REINTERVENTION AND SURVIVAL BETWEEN THE GROUPS. NO DEVICE ALLEGATIONS OF DEFICIENCIES SPECIFIC FOR GORE DEVICES.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11709841 ↗
• MalfunctionDec 3, 2019Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF A SUPERFICIAL FEMORAL ARTERY LESION WITH A GORE® VIABAHN® ENDOPROSTHESIS. FOLLOWING ADVANCEMENT TO THE TARGET LOCATION, DEPLOYMENT WAS INITIATED. THE DEPLOYMENT LINE WAS PULLED IN A SLOW STEADY MANNER AND IT WAS NOTED THAT ONLY APPROXIMATELY 1CM OF THE DEVICE HAD EXPANDED WHEN THE DEPLOYMENT LINE BROKE. THE LINE FRAGMENT WAS INSPECTED AND IT APPEARED FRAYED. THE PHYSICAN THEN CUT THE DELIVERY CATHETER OPEN, BUT THERE WAS NO DEPLOYMENT LINE TO BE FOUND. AN ADDITIONAL SHEATH WAS INSERTED AND ADVANCED TO THE PARTIALLY EXPANDED STENT. THE SHEATH WAS PUSHED UP AGAINST THE STENT AND THIS CAUSED THE STENT TO DEPLOY THE REST OF THE WAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9404802 ↗
• MalfunctionJun 12, 2019Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT PRESENTED FOR AN AXILLO-FEMORAL PROCEDURE. ALSO PLANNED WAS TREATMENT FOR THE FEMORO-POPLITEAL ARTERY. AS REPORTED, PATIENT HAS PERIPHERAL ARTERY DISEASE WITH PRE-EXISTING STENTS IN THE FEMORO-POPLITEAL ARTERY. IT IS UNKNOWN IF THE TARGET LESION WAS PRE-DILATED. A 7FR COOK ANSEL SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® ENDOPROSTHESIS OVER A .018 NITREX GUIDEWIRE. THE VIABAHN DEVICE WAS PLACED AT THE TARGET LESION AND DEPLOYMENT WAS INITIATED. HOWEVER, AFTER ABOUT 2 CM OF DEVICE EXPANSION, THE LINE BECAME STUCK AND THE DELIVERY CATHETER STARTED BOWSTRINGING. THE PHYSICIAN WAS ABLE TO PULL THE PARTIALLY EXPANDED DEVICE BACK INTO SHEATH. THE DEVICE WAS WITHDRAWN AND A NEW VIABAHN DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH GOOD OUTCOME. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8692490 ↗